[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prediabetic-state\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prediabetic-state":665},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,46,70,98,133,163,187,207,228,253,280,302,330,353,381,407,451,479,502,529,554,582,613,640],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100525222",false,"NCT06118931","Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control","The Impact of Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control","Inclusion Criteria:\n\n* Aged 40 years or older\n* Body mass index \\\u003C50 kg\u002Fm2\n* Have access to an Apple or Android cellphone with Bluetooth.\n* Have type 2 diabetes or be at risk for type 2 diabetes (defined as self-report of pre-diabetes, a recent (within 12 months) measure of HbA1c between 5.7 and 6.4%, waist circumference (WC) that is BMI specific; for women: BMI \\>= 18.5-24.9, WC \\>= 80cm; BMI \\>= 25-29.9, WC \\>= 90cm; BMI \\>= 30-34.9, WC \\>= 105cm; BMI \\>= 35+, WC \\>= 115cm; for men: BMI \\>= 18.5-24.9, WC \\>= 90cm; BMI \\>= 25-29.9, WC \\>= 100cm; BMI \\>= 30-34.9, WC \\>= 110cm; BMI \\>= 35+, WC \\>= 125cm.\n\nExclusion Criteria:\n\n* Individuals with type 2 diabetes will be excluded if: (1) currently on \\>2 monotherapies for diabetes, (2) have had diabetes therapy medication or dosage changes \\\u003C3 months, (3) self-reported hemoglobin A1c \\>9.0%, (4) taking exogenous insulin, or (5) taking sulfonylureas\n* The following exclusion criteria applies to all potential participants:\n\n  1. History of or referral for bariatric surgery\n  2. Weight loss \\>3% in the last 3 months\n  3. Taking antiobesity (weight loss) medications\n  4. Body weight \\>390lbs\n  5. Diagnosed with severe cognitive disorder that precludes them from giving consent\n  6. Inability or unwillingness to change their eating window to follow those prescribed in the study\n  7. Currently consistently eating during \\\u003C11.5 hour period .\n  8. Physician-diagnosed eating disorder\n  9. Having a pacemaker or receiving dialysis.\n  10. Not having access to a Lifelabs location.","ALL","40 Years",{"count":18,"type":19},123,"ESTIMATED","INTERVENTIONAL",[22],"NA","This study will evaluate the effectiveness of time-restricted eating (TRE), which is a form of intermittent fasting. When performing TRE, individuals consume all of their calories within a specific time window and then only consume water or other no calorie drinks the rest of the day. TRE is performed each day. There is no restriction on the quality or amount of food that people can consume during their eating window (ad libitum eating) with TRE, which can last anywhere from 4 to 12 hours. We are comparing three different 9-hour eating windows to determine whether the start and stop time of the eating window impact blood sugar control in individuals with obesity who also have or are at risk for type 2 diabetes. We also aim to determine if there are differences in the effects of the timing of eating window between males and females.",[25,26,27,28],"Diabetes Mellitus, Type 2","Obesity","Prediabetic State","Hyperglycemia",[30,31,26,32],"Time-restricted eating","Type 2 Diabetes","Glycemic Control","RECRUITING","2026-06-26",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":37},"2025-06-28",{"date":41,"type":19},"2027-06-28",{"name":43,"class":44},"University of Toronto","OTHER",1,{"id":47,"slug":4,"hasResults":10,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":10,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":20,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100548844","NCT06426277","Effectiveness of the Brazilian Diabetes Prevention Program","Effectiveness of the Diabetes Prevention Program on the Incidence of Type 2 Diabetes Mellitus Among Brazilian Individuals: Randomized Clinical Trial (PROVEN-DIA Study)","PROVEN-DIA","Inclusion Criteria\n\n* Be 18 years or older (no maximum age for being eligible)\n* Have a body mass index (BMI) between 18,5 and 34,9kg\u002Fm²\n* Have, at least, one electronic device (includes any of the following devices):\n\n  * Computer\n  * Laptop\u002Fnotebook\n  * Tablet\n  * Smartphone\n* Have access to internet (broadband, 3G, 4G, 5G, among others) Without previous nutritional counseling (within the 6 months prior to recruitment\u002Frandomization\u002Fintervention) Without supervision by a Physical Education Professional (Personal Trainer) in the past 6 months\n* Living near the research center (at maximum 60 minutes)\n* Diagnosis of prediabetes defined as two HbA1c measurements between 5.7% and 6.4% collected 7 to 90 days apart.\n\nExclusion Criteria:\n\n* Diagnosis of Diabetes Mellitus (including current or recent use, within three months, of glucose-lowering medication)\n* Underlying disease likely to limit life expectancy and\u002For increase the risk of interventions influencing the risk of developing T2D\n* Diagnosis of Renal Disease\n* Diagnosis of Pulmonary Disease\n* Gastrointestinal Disease\n* Secondary prevention for Cardiovascular Disease\n* Endocrine Diseases\n* Weight loss exceeding 10% in the last 6 months (except postpartum-related)\n* Uncontrolled Hypertension\n* Diagnosis of Polycystic Ovary Syndrome (self-reported)\n* Patients undergoing treatment for Tuberculosis (except those using isoniazid \\[INH\\] as prophylaxis)\n* Presence of diseases that may severely reduce life expectancy or the ability to participate in the study\n* Pregnant or breastfeeding women\n* Severe psychiatric disorders that, in the opinion of the clinical team, hinder participation in the program\n* Acute or chronic excessive alcohol consumption\n* Congestive Heart Failure (CHF) with a New York Heart Association Functional Class (NYHA) \\> 2\n* Need for referral to a cardiologist according to the Physical Activity Readiness Questionnaire (PAR-Q)\n* Current or recent participation (within the last six months) in another clinical trial that impacts the interventions and\u002For is associated with the study outcomes (in case of doubt, contact the coordinating center)\n* Likely relocation away from the research collaborating center within the next 3 years\n* Another household member is a participant or a team member of the PROVEN-DIA study\n* Unwillingness to accept treatment assignment by randomization and\u002For refusal to participate in the study (signing the Informed Consent Form)\n* Continuous use of the following medications:\n\nCorticosteroids other than topical, ophthalmic, or inhaled preparations Antineoplastic agents Psychoactive agents Other medications.\n\n• Participant from the pilot Randomized Clinical Trial (Brazilian Diabetes Prevention Program: Pilot Study (PROVEN-Dia), NCT05689658)","18 Years",{"count":55,"type":19},1305,[22],"The aim of this multicenter, randomized controlled trial is to assess the effectiveness of the Brazilian Diabetes Prevention Program (delivered face-to-face or via e-health) in preventing type 2 diabetes (T2D) in at least 1,305 adults at high risk of T2D over a 3-year follow-up period. Our outcomes include the incidence of T2D, body weight (kg), BMI, glycemic biomarkers, use of antidiabetic drugs, the proportion of individuals achieving controlled glycemia or HbA1c levels without medication, diet quality, moderate-to-vigorous physical activity (min\u002Fweek), prevalence of physical inactivity, sleep quality, perceived stress, alcohol consumption, smoking, and quality of life. In addition, social, cultural, educational, and geographical factors at the community level will be analyzed throughout the follow-up to determine their association with the incidence of T2D.",[27,59],"Pre Diabetes","2026-06-22",{"date":62,"type":37},"2026-06-25",{"date":64,"type":37},"2024-12-01",{"date":66,"type":19},"2029-12-31",{"name":68,"class":44},"Beneficência Portuguesa de São Paulo",2,{"id":71,"slug":4,"hasResults":10,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":10,"sex":15,"minAge":77,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":20,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100560731","NCT06580964","Heat and Exercise in Aging as Therapy (HEAT)","Glycemic Control and Frailty Risk in Older People at Risk for Type 2 Diabetes: Impact of Local Heat Therapy","HEAT","Inclusion Criteria:\n\n* Age ≥ 50 years\n* Women who are postmenopausal, defined as no menstrual period for at least 12 consecutive months.\n* Sedentary (structured exercise \\\u003C30 minutes, 3x\u002Fweek)\n* Body weight is at least 110 lbs\n* Meet criteria for prediabetes (fasting blood glucose 100-125 mg\u002Fdl, hemoglobin A1c 5.7-6.4%)\n* Consume \\\u003C8 (women) or \\\u003C15 (men) alcohol-containing beverages per week\n* Do not use nicotine or cannabis\n* Not taking any medications that could interfere with responses to the interventions (e.g., corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta blockers, sulfonylureas, insulin, metformin, anticoagulants, barbiturates, insulin sensitizers, fibrates, immunosuppressants). If you don't know, that's okay. We'll ask what medications you are on and check whether they fall into one of these categories.\n\nExclusion Criteria:\n\n* History of peripheral neuropathies\n* Currently taking prescription blood thinners\n* Medical complications that could would contraindicate participation in the high intensity interval training (HIIT) intervention including: orthopedic complications that would limit your ability to perform cycling exercise, significant cardiovascular impairments (e.g., history of arrhythmias, severe uncontrolled hypertension, etc.), diagnosed metabolic disease (e.g., diabetes), renal disease, sickle cell anemia, or cancer in remission for \\\u003C6 months.\n* Known history of slow wound healing\n* Lidocaine allergy\n* Latex allergy\n* Currently pregnant\n* \\>1.5\" subcutaneous fat over the thigh muscle\n* Symptoms suggestive of cardiovascular, respiratory, metabolic, or renal diseases including discomfort, pressure, or pain in your chest, neck, jaw, arms, calves, or other areas potentially related to ischemia; shortness of breath at rest or with mild exertion; dizziness or fainting (syncope); difficulty breathing while lying flat (orthopnea) or sudden nighttime breathing difficulties (paroxysmal nocturnal dyspnea); palpitations or rapid heartbeat (tachycardia); pain or cramping in your legs during physical activity (intermittent claudication); a known heart murmur; swelling in your ankles (edema); unusual fatigue or shortness of breath during routine activities or at rest.","50 Years",{"count":79,"type":19},54,[22],"The main goal of this two-phase clinical trial is to learn whether local heat therapy, using heat pads applied to the legs, can enhance skeletal muscle health, physical function, and blood sugar control in a manner comparable to exercise, specifically High-Intensity Interval Training (HIIT), in older individuals with prediabetes. The study aims to answer the following questions:\n\n1. Does local heat therapy improve muscle architecture (e.g., muscle cross-sectional area, capillary density, mitochondrial content), glucose tolerance, and frailty indicators similarly to HIIT in older individuals with prediabetes?\n2. Does local heat therapy as a pre-conditioning method enhance the skeletal muscle response to HIIT in older individuals with prediabetes?",[27],[84,85,86,87,88],"Exercise","Heat","Aging","Prediabetes","Skeletal Muscle","2026-06-18",{"date":91,"type":37},"2026-06-23",{"date":93,"type":37},"2025-11-06",{"date":95,"type":19},"2029-07-31",{"name":97,"class":44},"Texas Tech University",{"id":99,"slug":4,"hasResults":10,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":10,"sex":15,"minAge":105,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":20,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":45},"100639789","NCT07605169","Long-term Health and Economic Effects of an Individualized Lifestyle Intervention (LI-PAD-Extended)","Long-term Follow-up of Individualized Lifestyle Intervention Focused on Physical Activity and Diet: Effects on Weight Loss, Dietary Habits, Cardiovascular Health, Motivation, Health-related Quality of Life, and Health Economics (LI-PAD-Extended)","LI-PAD-EXTENDE","Inclusion Criteria:\n\n* Adults aged 45-65 years at baseline of the original LI-PAD study\n* Body mass index (BMI) ≥28 and ≤34\n* Completed the original LI-PAD study\n* Able and willing to attend follow-up assessments and provide necessary data\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Known coronary artery disease (clinical symptoms or earlier event)\n* Inability to understand the language used in the study\n* Inability to complete follow-up assessments at 18 months\n* Severe illness or medical condition that, in the investigator's opinion, precludes participation in follow-up assessments","45 Years","65 Years",{"count":108,"type":19},103,[22],"The goal of this clinical trial is to learn if an individualized lifestyle intervention works to improve weight, diet, physical activity, cardiovascular health, health-related quality of life, and cost-effectiveness in overweight and obese adults aged 45-65 years.\n\nThe main questions it aims to answer are:\n\nDoes the intervention lead to sustained weight loss after 18 months?\n\nDoes the intervention improve cardiovascular risk factors, metabolic markers, and health-related quality of life compared to general written advice?\n\nIs the intervention cost-effective?\n\nResearchers will compare the individualized lifestyle intervention to a control group that receives general written advice on physical activity and diet to see if the intervention provides greater long-term health and economic benefits.\n\nParticipants will:\n\nAttend counseling sessions with a health promoter Take part in supervised aerobic and resistance training with a physiotherapist Use swimming facilities and participate in the Lifestyle School Access a digital health coach and the online Lifestyle Tool Complete measurements of body weight, diet, physical activity, and cardiovascular health markers (waist-to-hip ratio, blood pressure, blood lipids, fasting glucose, HbA1c, CRP, and liver enzymes) Complete assessments of resting energy expenditure, aerobic fitness, muscle strength, motivation, and health-related quality of life Provide blood samples at baseline, 6 months, and 18 months for dietary biomarker analysis Contribute data for health economic evaluation to assess cost-effectiveness",[112,26,27],"Overweight",[114,115,116,117,112,26,118,119,120,121,122],"Lifestyle intervention","Physical activity","Diet","Precision health","Weight loss","Cardiometabolic risk","Health-related quality of life","Behavioral support","Cost-effectiveness","2026-05-19",{"date":125,"type":37},"2026-05-22",{"date":127,"type":37},"2025-08-11",{"date":129,"type":19},"2027-12-31",{"name":131,"class":132},"Vastra Gotaland Region","OTHER_GOV",{"id":134,"slug":4,"hasResults":10,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":10,"sex":15,"minAge":53,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":4},"100638273","NCT07584330","AI-Driven Metabolic Cohort in Overweight\u002FObese Chinese Adults","Chinese Overweight\u002FObese - Diabetes Metabolic Spectrum Cohort: An Artificial Intelligence-Driven Prospective Study","COMET-AI","Inclusion Criteria:\n\n1. Able to understand and voluntarily sign the informed consent form, and willing to comply with all study requirements.\n2. Age between 18 and 60 years (inclusive).\n3. Meets at least one of the following overweight\u002Fobesity criteria: a) BMI ≥ 24 kg\u002Fm²; b) male waist circumference ≥ 90 cm, female waist circumference ≥ 85 cm.\n4. Capable of basic smartphone operation and able to use WeChat or similar communication tools for daily communication.\n\nExclusion Criteria:\n\n1. Diagnosis of type 1 diabetes, latent autoimmune diabetes in adults (LADA), maturity-onset diabetes of the young (MODY), or other specific types of diabetes.\n2. Endocrine or metabolic diseases that may affect body weight, including untreated thyroid disorders (hyperthyroidism: TSH \\\u003C 0.1 mIU\u002FL with FT4 \\> upper normal limit; hypothyroidism: TSH \\> 10 mIU\u002FL), Cushing syndrome, acromegaly, polycystic ovary syndrome, or hypopituitarism.\n3. Severe liver disease (Child-Pugh class B or C).\n4. Renal insufficiency (estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²).\n5. Severe cardiac dysfunction (New York Heart Association class III or IV).\n6. Major cardiovascular or cerebrovascular event within the past 3 months (acute coronary syndrome, stroke).\n7. Uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg or diastolic ≥ 110 mmHg) or uncontrolled diabetes (HbA1c ≥ 9.0%).\n8. Active malignancy (diagnosed or treated within the last 3 years).\n9. Inflammatory bowel disease or conditions causing malabsorption (Crohn disease, active ulcerative colitis, pancreatitis with steatorrhea).\n10. Neuropsychiatric disorders (anorexia nervosa, bulimia nervosa, schizophrenia, major depression, or bipolar disorder).\n11. Diseases or physical conditions that impair motor function (severe osteoarthritis, Parkinson disease, paralysis, or cardiopulmonary insufficiency).\n12. Long-term use of antipsychotic drugs, systemic glucocorticoids, or other medications judged by the investigator to affect study outcomes.\n13. Pregnancy or planned pregnancy during the study period.\n14. History of or planned organ transplantation.\n15. Inability to operate the AI-based system or comply with follow-up procedures.\n16. Concurrent participation in another interventional clinical trial that may influence the results of this study.\n17. Unwilling or unable to provide informed consent.","60 Years",{"count":142,"type":19},2800,"OBSERVATIONAL","The goal of this observational cohort study is to delineate the five-year dynamic trajectories of metabolic phenotypes in Chinese adults with overweight or obesity, with or without type 2 diabetes, focusing on transition rates from metabolically healthy overweight\u002Fobesity to unhealthy overweight\u002Fobesity or to type 2 diabetes, as well as the incidence and progression of diabetic complications and cardiovascular events in those with type 2 diabetes and overweight\u002Fobesity. Researchers will compare three phenotype groups, namely metabolically healthy overweight\u002Fobesity, metabolically unhealthy overweight\u002Fobesity, and type 2 diabetes with overweight\u002Fobesity, to assess differences in metabolic parameter changes, complication rates, and cardiovascular risk. Participants will use a digital health management platform for data upload and lifestyle support, and will complete comprehensive health assessments at baseline, at 2.5 years, and at 5 years, along with annual light follow-ups.",[146,25,27,147],"Overweight and Obesity","Metabolic Syndrome",[146,149,147,150,151,152],"Type 2 Diabetes Mellitus","Metabolic Phenotype","Prospective Study","Cohort Study","NOT_YET_RECRUITING","2026-05-07",{"date":156,"type":37},"2026-05-13",{"date":158,"type":19},"2026-05-01",{"date":160,"type":19},"2032-04-01",{"name":162,"class":44},"Zhujiang Hospital",{"id":164,"slug":4,"hasResults":10,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":10,"sex":15,"minAge":105,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":20,"phases":172,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":45},"100448784","NCT05123963","Restoring 24-hour Substrate Rhythmicity to Improve Glycemic Control by Timing of Lifestyle Factors","TIMED","Inclusion Criteria:\n\n* Pre-diabetes:\n\n  * Fasting plasma glucose: 6.1 to 6.9 mmol\u002FL or\n  * 2-hour plasma glucose post 75g OGTT: 7.8 to 11.0 mmol\u002FL and\n  * HbA1c: 6.0 to 6.4%\n  * or Insulin resistant: glucose clearance rate ≤ 360 ml\u002Fkg\u002Fmin as determined using the Oral Glucose Insulin Sensitivity Index at Time 120 min.\n* BMI \\> 25 kg\u002Fm2\n* To be willing and able to adhere to the specifications of the protocol;\n* To have signed an informed consent document indicating that they understood the purpose of and procedures required for the study and were willing to participate in the study.\n\nExclusion Criteria:\n\n* overt cardiovascular disease as assessed by medical history, physical exam, and abnormal ECG\n* Treatment with any drug known to affect lipid or carbohydrate metabolism, except statins (to be stopped 3 weeks prior to study A), metformin or anti-hypertensive drugs (to be stopped 7 days prior to the studies);\n* presence of liver or renal disease other than uncomplicated NASH or mild isolated proteinuria; uncontrolled thyroid disorder;\n* Uncontrolled severe hypertension, systolic pressure ≥ 180 mm Hg or diastolic pressure ≥ 110 mm Hg;\n* History of ischemic heart disease, tachyarrhythmia, QT interval prolongation, risk factors for torsade de pointes (eg hypokalemia), or taking any medication known to prolong the QT interval;\n* History of serious gastrointestinal disorders (malabsorption, peptic ulcer, gastroesophageal reflux requiring surgery, etc.);\n* Presence of a pacemaker;\n* Having undergone a PET study or CT scan in the past year;\n* Any contraindication to stopping statins for 3 months and stopping an anti-hypertensive medication and metformin for 7 days;\n* smoking (\\>1 cigarette\u002Fday) and\u002For consumption of \\>2 alcoholic beverages per day;\n* No blood donation two month prior the study;\n* prior history or current fasting plasma cholesterol level \\> 7 mmol\u002Fl or fasting TG \\> 6 mmol\u002Fl.","75 Years",{"count":171,"type":19},48,[22],"Exercise is well-known to improve skeletal muscle energy metabolism and is an established intervention to improve muscle insulin sensitivity and to counter the development of type 2 diabetes (T2D). However, given the 24h rhythmicity in substrate metabolism previously observed in healthy, lean men and the lack of such rhythmicity in men with insulin-resistance, the investigator hypothesize that appropriate timing of exercise training can maximize the metabolic health effects of exercise. Indeed, a preliminary study in humans revealed that afternoon high-intensity interval training (HIIT) exercise was more effective than morning exercise in improving 24h blood glucose levels in men with T2D. Another recent study in mice showed that the time of day is a critical factor in augmenting the beneficial effects of exercise on the skeletal muscle metabolome as well as on whole-body energy homeostasis. However, human studies that specifically target the impact of timing of exercise training on glucose homeostasis and metabolic health are scarce and the potential underlying mechanisms largely unknown.\n\nThe overarching goals of this project is to improve 24-hour rhythmicity of metabolism in men and women with prediabtes by appropriate timing of exercise and to assess its effect on metabolic health and immune response. Acute and prolonged exercise interventions timed in the morning vs late afternoon will be carried out in individuals with prediabetes to determine whether acute exercise in the afternoon and prolonged exercise training in the afternoon can improve peripheral insulin sensitivity, compared to exercise in the morning, and positively affect adipose tissue dietary fatty acid storage and partitioning of dietary fatty acids in skeletal muscles.",[27],[176,177],"Postprandial metabolism","High-intensity interval training","2026-05-05",{"date":180,"type":37},"2026-05-11",{"date":182,"type":37},"2021-09-15",{"date":184,"type":19},"2027-12-30",{"name":186,"class":44},"Université de Sherbrooke",{"id":188,"slug":4,"hasResults":10,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":193,"sex":15,"minAge":53,"maxAge":106,"enrollmentInfo":194,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":45},"100635795","NCT07557329","Intestinal Endotoxemia and Beta- Cell Dysfunction in Prediabetics","Association Between Intestinal Endotoxemia and Beta-Cell Dysfunction in Lean Prediabetics","Inclusion Criteria:\n\n* Age: 18-65 years\n* BMI: 18.5-24.9 kg\u002Fm²\n* ADA prediabetes: FPG 100-125 mg\u002FdL OR 2hPG 140-199 mg\u002FdL OR HbA1c 5.7-6.4%\n* HOMA-IR \\\u003C1.5 (key inclusion criterion)\n\nExclusion Criteria:\n\n* \\- HOMA-IR ≥1.5\n* BMI ≥25 kg\u002Fm²\n* Diabetes, acute inflammation, GI disorders (Table 1) Group II (Controls): Lean normoglycemic ; age and sex-matched healthy subjects",true,{"count":195,"type":19},120,"the goal of this observation study is to learn about association between intestinal endotoxemia and prediabetes lean patients with the aim of prevention of diabetes in those category of patients",[198,27],"Prediabetic State (IGT)","2026-04-29",{"date":178,"type":37},{"date":202,"type":19},"2026-05",{"date":204,"type":19},"2027-06",{"name":206,"class":44},"Sohag University",{"id":208,"slug":4,"hasResults":10,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":10,"sex":15,"minAge":53,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":20,"phases":216,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":45},"100503421","NCT05835037","Effect of Zinc on Glucose Homeostasis","Clinical and Nutrigenetic Assessment of Zinc in Participants With Prediabetes","Inclusion Criteria:\n\n* Amish men or women who are 18 to 80 years old\n* Prediabetes (HgbA1c = 5.7-6.4% or fasting glucose levels 100-125 mg\u002FdL)\n\nExclusion Criteria:\n\n* Pregnant\n* Currently breastfeeding\n* History of severe gastrointestinal disorders or upper gastrointestinal surgery\n* Has hemochromatosis, cancer, liver disease, kidney disease, cardiovascular disease, or other coexisting malignancy\n* Hemoglobin \\\u003C 12.5 g\u002Fdl (male) or \\\u003C 11 g\u002Fdl (female)\n* Severe hypertension (blood pressure \\> 160\u002F95 mm Hg)\n* Has a creatinine greater than 2.0 mg\u002Fdl, aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 2 times the upper limit of normal, hematocrit (Hct) less than 32%, or thyroid-stimulating hormone (TSH) less than 0.4 or greater than 5.5 milli-international units (mIU) per liter.\n* At the discretion of the study physician or PI, taking medications that affect the outcomes of the study including, but not limited to, corticosteroids, anti-psychotic agents, protease inhibitors, oral contraceptives, estrogens, niacin, and some classes of antidepressants, statins, and antihypertensive medications\n* Zinc hypersensitivity\n* Use of denture adhesive containing zinc\n* Taking other medications or zinc-containing supplements and is unwilling or cannot safely, in the opinion of the study physician, discontinue their use at least 2 weeks prior to protocol initiation\n* Any other condition that would, in the opinion of the investigator, place them at an unacceptable risk or render them unable to meet the requirements of the protocol.","80 Years",{"count":215,"type":19},200,[217],"PHASE4","The purpose of this investigation is to evaluate the impact of zinc supplementation on fasting glucose levels, hemoglobin A1c (HbA1c), and other indices of glucose homeostasis in individuals with prediabetes. The investigators hypothesize that prediabetic subjects receiving zinc will demonstrate a greater decrease in HbA1c and blood glucose compared to prediabetic subjects receiving placebo.\n\nSpecific Aim: Conduct a prospective, double-blind randomized clinical trial comparing the effects of 12 months of zinc supplementation (zinc gluconate 30 milligram \\[mg\\] per day) versus placebo on glucose homeostasis. Based upon expected effect size and power calculations, and anticipating a 20% drop-out rate, the investigators will study 200 prediabetic subjects (100 per group) using a 1:1 randomization design. HbA1c, fasting plasma glucose, and other measures will be obtained at 0, 6, and 12 months and will be compared between zinc supplementation and placebo groups.",[27,28],"2026-04-28",{"date":178,"type":37},{"date":223,"type":37},"2024-02-16",{"date":225,"type":19},"2028-07",{"name":227,"class":44},"University of Maryland, Baltimore",{"id":229,"slug":4,"hasResults":10,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":10,"sex":234,"minAge":77,"maxAge":169,"enrollmentInfo":235,"targetDuration":4,"studyType":20,"phases":236,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":45},"100466264","NCT05351476","Exercise Training and Fat Metabolism in Postmenopausal Women","Resistance Training Modulation of Fat Metabolism in Obese Postmenopausal Women","Inclusion Criteria:\n\n* Women\n* Postmenopausal (50-75 yrs.)\n* Obese (BMI 30-50 kg\u002Fm2)\n* Prediabetes (HbA1c 5.7 - 6.4% or fasting blood glucose 100 to 125 mg\u002FdL, or 2hr OGTT blood glucose 140 to 199 mg\u002FdL)\n* Sedentary (not performing purposeful exercise training more than 20 minutes per day twice a week)\n* Non-smokers\n* No hormone replacement therapy for at least the past two years.\n\nExclusion Criteria:\n\n* Engaging in purposeful resistance training or endurance training (\\> 20min\u002Fday, \\> 2 days\u002Fweek)\n* Resting blood pressure above 140 mmHg systolic or 90 mmHg diastolic\n* Type 1 or type 2 diabetes\n* Medical problems in which exercise is contraindicated, such as chronic infections\n* History of, or currently presentation with, cancer, cardiovascular or respiratory disease\n* Uncontrolled thyroid dysfunction, liver or renal dysfunction\n* Taking any medication affecting lipid metabolism\n* Musculoskeletal disease or injury that would otherwise prevent engagement in resistance and endurance training\n* Smokers and those with diagnosed eating disorders","FEMALE",{"count":195,"type":19},[22],"Adipose tissue turnover plays a critical role in body weight maintenance, and obesity is underscored by the dysregulated balance between fat breakdown and synthesis. Although there are clear health-related benefits of physical activity, little is known about how resistance exercise, as opposed to endurance exercise, can reduce the risk of metabolic disorders, particularly in women. The goal of the proposed study is to investigate the effectiveness of resistance training to improve basal and stimulated fat metabolism in postmenopausal women with obesity and pre-diabetes, potentially serving as a viable and practical approach to prevent the onset of type 2 diabetes.",[239,26,27],"Postmenopausal Symptoms",[241,242,243],"Resistance Exercise","Fat Metabolism","Postmenopause","2026-04-07",{"date":246,"type":37},"2026-04-13",{"date":248,"type":37},"2022-05-20",{"date":250,"type":19},"2027-04-30",{"name":252,"class":44},"Florida State University",{"id":254,"slug":4,"hasResults":10,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":10,"sex":15,"minAge":53,"maxAge":106,"enrollmentInfo":259,"targetDuration":4,"studyType":20,"phases":261,"briefSummary":263,"conditions":264,"keywords":268,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":45},"100623974","NCT07403604","Effect of Insulin Lowering on Lipogenesis","Human Models of Selective Insulin Resistance: Diazoxide, Part I","Inclusion Criteria:\n\n* Adults aged 18-65 years\n* Body mass index of 30-45 kg\u002Fm2\n* Able to understand written and spoken English and\u002For Spanish\n* Able to have pre-randomization screening labs drawn and study protocol initiated within 60 days of eligibility determination\n* Presence of uncomplicated metabolic dysfunction-associated steatotic liver disease (MASLD) by vibration-controlled transient elastography (VCTE)\n\n  * Steatosis score of S1-S3\n  * Fibrosis score of F0-F2 (Note that if VCTE result is available from within past 6 months, then do not have to repeat VCTE for study purposes)\n* Evidence of insulin resistance, represented by any or all of the following criteria:\n\n  * Meeting either of the American Diabetes Association's definitions for prediabetes or impaired fasting glucose (IFG) on screening labs:\n\n    * Prediabetes: Hemoglobin A1c 5.7-6.4%\n    * IFG: plasma glucose of 100-125 mg dL-1 after ≥ 8-h fast\n  * Homeostasis Model of Insulin Resistance (HOMA-IR) score ≥ 2.73\n* Fasting hyperinsulinemia (fasting insulin level ≥ 13 μU\u002FmL) on screening labs\n* Written informed consent (in English or Spanish) and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.\n\nExclusion Criteria:\n\n* Unable to provide informed consent in English or Spanish\n* Concerns arising at screening visit (any of the following):\n\n  * Documented weight loss of ≥ 5.0% of baseline within the previous 3 months\n  * Abnormal blood pressure (including on treatment, if prescribed)\n\n    * Systolic blood pressure (SBP) \\\u003C 90 mm Hg or \\> 160 mm Hg, and\u002For\n    * Diastolic blood pressure (DBP) \\\u003C 60 mm Hg or \\> 100 mm Hg\n  * Resting heart rate \\\u003C 55 bpm or ≥ 110 bpm\n  * Abnormal screening electrocardiogram (or if on file, performed within previous 90 days)\n  * Laboratory evidence of diabetes mellitus:\n\n    * Hemoglobin A1c ≥ 6.5%, and\u002For\n    * Fasting plasma glucose ≥ 126 mg\u002FdL\n  * Positive qualitative serum β-human chorionic gonadotropin (β-hCG, i.e., pregnancy test) in women of childbearing potential\n  * Liver function abnormalities: transaminases (aspartate aminotransferase or alanine aminotransferase) \\> 3.0 x the upper limit of normal, and\u002For total bilirubin \\> 1.25 x the upper limit of normal\n  * Abnormal screening fasting triglycerides \\> 500 mg\u002FdL\n  * Abnormal screening serum electrolytes that are considered clinically significant according to the clinical judgment of the PI\n  * Creatinine equating to estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n  * Abnormal screening blood counts (any of the following):\n\n    * Hemoglobin \\\u003C 10 g\u002FdL\n    * White blood cell count below the lower limit of normal for sex\n    * Platelet count below the lower limit of normal for sex\n  * Uric acid level above the upper limit of normal\n* Reproductive concerns\n\n  * Women currently pregnant (tested by serum and\u002For urine β-hCG)\n  * Women currently breastfeeding\n* Concerns related to glucose metabolism\n\n  * History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes):\n\n    * Hemoglobin A1c ≥ 6.5%\n    * Plasma glucose ≥ 126 mg\u002FdL after 8-h fast\n    * Plasma glucose of ≥ 200 mg\u002FdL at 2 h after ingestion of a 75-g glucose load\n    * Random plasma glucose ≥ 200 mg\u002FdL associated with typical hyperglycemic symptoms, diabetic ketoacidosis, or hyperglycemic-hyperosmolar state\n  * History of gestational diabetes mellitus within the previous 5 years\n  * Use of antidiabetic medications except metformin within the 90 days prior to screening\n  * Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)\n* Concerns related to lipid metabolism\n\n  * Known diagnoses of familial hypercholesterolemia, familial combined hyperlipidemia, or familial hyperchylomicronemia\n  * Use of fibrates, prescription-strength omega-3 fatty acids, or high-dose niacin within the 90 days prior to screening:\n* Known, documented history (i.e., not to be newly screened\u002Ftested for study purposes), at the time of screening, of any of the following medical conditions:\n\n  * Pancreatic pathology, including but not limited to neoplasia, pancreatitis, pancreatectomy\n  * Cardiovascular disease (N.B. uncomplicated hypertension is not exclusionary)\n\n    * Atherosclerotic cardiovascular disease: stable or unstable angina, myocardial infarction, ischaemic or hemorrhagic stroke, or transient ischaemic attack, peripheral arterial disease (claudication), use of dual antiplatelet therapy (aspirin + P2Y12 inhibitor), history of percutaneous coronary intervention\n    * Heart rhythm abnormalities\n    * Congestive heart failure of any New York Heart Association class\n    * Symptomatic valvular heart disease (e.g., aortic stenosis)\n    * Pulmonary hypertension\n  * Chronic kidney disease, Stage 3 or higher (estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F 1.73 m2), of any cause\n  * Chronic liver disease other than uncomplicated MASLD, including but not limited to:\n\n    * Advanced liver fibrosis, as determined by non-invasive testing, including fibrosis scores of F3-F4 on VCTE\n    * Cirrhosis of any etiology\n    * Autoimmune hepatitis or other rheumatologic disorder affecting the liver\n    * Biliopathy (e.g., progressive sclerosing cholangitis, primary biliary cholangitis)\n    * Chronic liver infection (e.g., viral hepatitis, parasitic infestation)\n    * Hepatocellular carcinoma\n    * Infiltrative disorders (e.g., sarcoidosis, hemochromatosis, Wilson disease)\n  * Gout\n  * Chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)\n  * Malabsorptive conditions\n  * Active seizure disorder (including controlled with antiepileptic drugs)\n  * Psychiatric diseases that are or have been decompensated within 1 year of screening, and\u002For require use of antipsychotic drugs associated with significant weight gain\u002Fmetabolic dysfunction (e.g., clozapine, olanzapine), monoamine oxidase inhibitors, tricyclic antidepressants, or lithium\n  * Known glucose-6-phosphate dehydrogenase (G6PD) deficiency\n  * Other clinically significant endocrinopathies\n  * Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation\n  * Active malignancy, or hormonally active benign neoplasm, except allowances for non-melanoma skin cancer and differentiated thyroid cancer (Stage I only)\n  * Clinical concern for increased risk of volume overload or hypotension (SBP \\\u003C90 and\u002For DBP \\\u003C60 mm Hg), including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n* Clinical concern for increased risk of volume overload or hypotension (SBP \\\u003C90 and\u002For DBP \\\u003C60 mm Hg), including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n* Use of certain medications currently or within 90 d prior to screening:\n\n  * Prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 90 d prior to screening, except allowances for:\n\n    * Statins for primary prevention of cardiovascular disease\n    * Use of drugs prescribed for indications other than the exclusionary diagnoses\u002Fpurposes listed above (e.g., non-hydantoin antiepileptic drugs used for non-seizure indications, angiotensin converting enzyme inhibitor\u002Fangiotensin receptor blocker used for uncomplicated hypertension rather than for congestive heart failure, etc.)\n    * Vasodilating drugs for any indication: hydralazine, nitrates, phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil), minoxidil (oral)\n    * Phenytoin or fosphenytoin for any indication\n    * Oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 90 days; topical and inhaled formulations are permitted\n* History of certain weight-loss (bariatric) surgeries, including:\n\n  * Roux-en-Y gastric bypass\n  * Biliopancreatic diversion\n  * Restrictive procedures (lap band, sleeve gastrectomy) performed within past year\n* Clinical concern for alcohol overuse, including based on chart review and\u002For by participant's report of consuming more than 14 standard drinks per week for males or more than 7 standard drinks per week for females\n* Regular use of tobacco, either daily or an average of at least 1 cigarette per day, and\u002For nicotine vaping more than 1 day per week\n* Positive urine drug screen, except for lawfully prescribed medications or marijuana\u002Ftetrahydrocannabinol positivity, provided that the participant agrees not to use it during the same period that they will abstain from alcohol)\n* Atypical circadian rhythm, such as due to night shift work, within 30 days of screening or expected within 30 days of each treatment period\n* History of severe infection or ongoing febrile illness within 14 days of screening\n* Any other disease or condition or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and\u002For interfere with the analysis of study data.\n* Known allergy\u002Fhypersensitivity to any component of the medicinal product formulations (including sulfa drugs), other biologics, intravenous (IV) infusion equipment, plastics, adhesive or silicone, history of infusion site reactions with IV administration of other medicines, or ongoing clinically important allergy\u002Fhypersensitivity as judged by the investigator.\n* Concurrent enrollment in another clinical study of any investigational drug therapy or use of any biologicals within 5 half-lives of an investigational agent or biologic",{"count":260,"type":19},25,[262],"PHASE1","The goal of this clinical trial is to compare a one-week course of diazoxide (2 mg\u002Fkg per dose x 14 doses) and placebo in people with obesity and insulin resistance (IR) with metabolic dysfunction-associated steatotic liver disease (MASLD). The main question it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects hepatic de novo lipogenesis, a major contributor to MASLD pathophysiology.\n\nParticipants will:\n\n* Take 14 doses of placebo over 7 days, followed 4-12 weeks later by either 14 doses of diazoxide (at 2 mg per kg of body weight per dose \\[mpk\\]) or another 14 doses of placebo, over 7 days\n* Take 18 doses of heavy (deuterated) water (50 mL each) over 7 days, twice\n* Have blood drawn and saliva collected after an overnight fast on four mornings over the course of the study\n* Undergo insulin suppression tests (IST) to assess the degree of insulin resistance at the end of each 1-week study period\n* Consume their total calculated daily caloric needs as divided into three meals per day\n\nResearchers will compare blood tests at the beginning and end of each 1-week study period in participants randomized (like the flip of a coin) to receive either placebo followed by diazoxide or placebo followed by placebo, to see how the drug treatment affects de novo lipogenesis, serum insulin, plasma glucose, and other serum lipid parameters (triglycerides, free fatty acids), among others.",[265,266,267,27,26],"Hyperinsulinemia","Insulin Resistance","Non-Alcoholic Fatty Liver Disease",[265,266,269,267,270],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Triglycerides","2026-04-06",{"date":273,"type":37},"2026-04-09",{"date":275,"type":19},"2026-05-31",{"date":277,"type":19},"2029-09-30",{"name":279,"class":44},"Columbia University",{"id":281,"slug":4,"hasResults":10,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":193,"sex":15,"minAge":53,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":20,"phases":288,"briefSummary":289,"conditions":290,"keywords":291,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":45},"100543301","NCT06354088","Human Models of Selective Insulin Resistance: Alpelisib, Part I","Inclusion Criteria:\n\n1. Adults aged 18-70 years\n2. Able to understand written and spoken English and\u002For Spanish\n3. Body mass index of:\n\n   * For Group IS: BMI 18-25 kg\u002Fm2\n   * For Group IR: BMI 30-45 kg\u002Fm2\n4. Evidence of insulin sensitivity or insulin resistance:\n\n   * Insulin sensitive (for Group IS) defined as all of the following: (1) Fasting serum insulin ≤ 10 µIU\u002FmL, (2) Absence of dysglycemia (fasting plasma glucose \\\u003C 100 mg\u002FdL and hemoglobin A1c \\\u003C 5.7%), (3) Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score \\\u003C 2.5, and (4) Fibrosis-4 (FIB-4) score \\\u003C 1.3\n   * Insulin resistant (for Group IR) defined as fasting serum insulin ≥ 13 µIU\u002FmL plus at least one of the following: (1) Presence of prediabetic state (fasting plasma glucose 100-125 mg\u002FdL and\u002For hemoglobin A1c 5.7-6.4%), and\u002For HOMA-IR ≥ 2.5\n\nExclusion Criteria:\n\n1. Inability to provide informed consent in English or Spanish\n2. Concerns arising at screening visit:\n\n   * Abnormal vital signs: (1) Systolic blood pressure \\\u003C 90 mm Hg or \\> 160 mm Hg and\u002For (2) Diastolic blood pressure \\\u003C 55 mm Hg or \\> 100 mm Hg and\u002For (3) Abnormal resting heart rate \\\u003C 55 bpm (except at PI's discretion) or ≥ 110 bpm\n   * Abnormal screening serum electrolytes judged by the PI to be potentially clinically significant, including liver function abnormalities (either of the following): (1) Transaminases (AST or ALT) \\> 3.0 x the upper limit of normal and\u002For (2) Total bilirubin \\> 1.25 x the upper limit of normal\n   * Laboratory evidence of diabetes mellitus: (1) Hemoglobin A1c ≥ 6.5%, and\u002For (2) Fasting plasma glucose ≥ 126 mg\u002FdL\n3. Reproductive concerns i. Positive qualitative β-hCG (i.e., pregnancy test) in women of childbearing potential ii. Women currently pregnant iii. Women currently breastfeeding\n4. Concerns related to glucose metabolism\n\n   * History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes)\n   * History of gestational diabetes mellitus within the previous 5 years\n   * Use of most antidiabetic medications (other than metformin) within the 90 days prior to screening: thiazolidinediones, sulfonylureas, meglitinides, dipeptidyl peptidase-4 (DPP4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium-glucose cotransporter-2 (SGLT2) inhibitors, amylin mimetics, acarbose, insulin iv. Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)\n5. Concerns related to lipid metabolism\n\n   * Known diagnoses of familial hypercholesterolemia, familial combined hyperlipidemia, or familial hyperchylomicronemia in the participant or a first-degree relative\n   * Use of certain lipid-lowering drugs within 14 d prior to screening visit: fibrates (e.g., fenofibrate, gemfibrozil), prescription-strength omega-3 fatty acids (e.g., icosapent ethyl), high-dose niacin (\\>100 mg daily)\n6. Known, documented history, at the time of screening, of any of the following medical conditions:\n\n   * Significant cardiovascular diseases (N.B. uncomplicated hypertension is not exclusionary)\n   * Severe liver disease, including advanced fibrosis (e.g., fibrosis score F3-F4 by vibration-controlled transient elastography) and cirrhosis\n   * Psychiatric diseases causing functional impairment that: (1) Are or have been decompensated within 1 year of screening, and\u002For (2) Require use of anti-dopaminergic antipsychotic drugs associated with significant weight gain\u002Fmetabolic dysfunction (e.g., clozapine, olanzapine)\n   * Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation\n   * Bleeding disorders, including due to anticoagulation, or significant anemia (see above)\n   * Active malignancy, or hormonally active benign neoplasm, except allowances for non-melanoma skin cancer and differentiated thyroid cancer (Stage I only)\n7. Clinical concern for increased risk of volume overload, including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n8. Use of oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 30 days; topical and inhaled formulations are permitted\n9. History of certain weight-loss (bariatric) surgery, including:\n\n   * Roux-en-Y gastric bypass\n   * Biliopancreatic diversion\n   * Restrictive procedures (lap band, sleeve gastrectomy) performed within the past 6 months\n10. Clinical concern for alcohol overuse based on chart review and\u002For by recruit's report of more than 14 standard drinks per week for males or more than 7 standard drinks per week for females\n11. Regular use of tobacco, either daily or an average of at least 1 cigarette per day, and\u002For nicotine vaping more than 1 day per week\n12. Clinical concern for use of illicit drugs other than marijuana or lawfully prescribed medications based on recruit's report, chart review, and point-of-care urine drug test at screening\n13. History of or ongoing febrile illness within 30 days of screening\n14. Any other disease or condition or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and\u002For interfere with the analysis of study data.\n15. Known allergy\u002Fhypersensitivity to any component of the medicinal product formulations (including soy, cow dairy, or gluten), other biologics, venipuncture materials, plastics, adhesive or silicone, or ongoing clinically important allergy\u002Fhypersensitivity as judged by the investigator.\n16. Dietary restrictions (e.g., vegan, kosher, halal) on gelatin present in overencapsulation\n17. Concurrent enrollment in another clinical study of any investigational drug\u002Fbiologic therapy within 6 months prior to screening or within 5 half-lives of an investigational agent or biologic, whichever is longer.\n\n    * Prior participation in other studies led by Dr. Cook (PI) is excluded from this prohibition according to his medical\u002Fscientific judgment.","70 Years",{"count":287,"type":19},32,[262],"The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive \"tracer\" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day.\n\nThe objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels.",[266,27,146,267],[292,265,267,293,294,295],"Insulin resistance","Hepatic steatosis","De novo lipogenesis","Glucose production",{"date":273,"type":37},{"date":298,"type":37},"2024-04-24",{"date":300,"type":19},"2026-12-31",{"name":279,"class":44},{"id":303,"slug":4,"hasResults":10,"nctId":304,"briefTitle":305,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":193,"sex":15,"minAge":308,"maxAge":4,"enrollmentInfo":309,"targetDuration":311,"studyType":143,"phases":4,"briefSummary":312,"conditions":313,"keywords":316,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":45},"100296582","NCT03140865","Wake Forest Alzheimer's Disease Clinical Core","ADCC","Inclusion Criteria:\n\nGroup 1: Cognitively Normal (CN)\n\n1. No subjective complaints of cognitive impairment\n2. No cognitive impairment evident on formal testing interpreted by expert adjudication committee (typically, performance not worse than 1 SD below demographically relevant norms)\n3. Clinical Dementia Rating (CDR) = 0 or 0.5\n4. Normal glycemic control as indicated by American Diabetes Association (ADA) guidelines for normal 2 hour glycemic response to a glucose tolerance test (\\\u003C 140 mg\u002FdL).\n5. Reliable collateral or study partner available to attend Visit 1 at a minimum\n\nGroup 2: Mild Cognitive Impairment (MCI)\n\n1. Objective evidence of memory and\u002For executive function deficits on neuropsychological testing (typically 1.5 SD below demographically relevant norms)\n2. CDR = 0 or 0.5\n3. Reliable collateral or study partner\n\nGroup 3: Alzheimer's Disease (AD)\n\n1. Diagnosis of probable mild AD, diagnosed with NIA-AA criteria, or mixed AD and vascular pathology as long as there is not a large vessel territory stroke, adjudicated by expert consensus panel.\n2. Mini-Mental Status Exam (MMSE) score ≥ 10; CDR = ≥0.5\n3. Normal glycemic control or prediabetes\n4. Reliable collateral or study partner available to attend all visits\n\nExclusion Criteria:\n\n1. Clinically significant abnormal labs\n2. Significant neurologic disease that might affect cognition, other than AD, such as stroke, Parkinson's disease, multiple sclerosis, or recent severe head injury with loss of consciousness for more than 30 minutes within the last year, or with permanent neurologic sequelae\n3. Clinically significant medical illness or organ failure as determined by study clinicians, including severe, uncontrolled cardiovascular disease, oxygen-treated chronic obstructive pulmonary disease, severe liver disease, Stage 4 chronic kidney disease or impending dialysis, active cancer, or other life-limiting condition with life expectancy less than 3 years\n4. Current substance abuse or heavy alcohol consumption defined as \\>14 alcoholic drinks per week; or history of alcoholism or substance abuse within previous 10 years\n5. Current poorly controlled depression or other psychiatric illness as determined by clinical judgement of study clinicians or neuropsychologists\n6. Current use of anti-psychotic, benzodiazepines (PRN use \\\u003C3 times per week is acceptable), anti-coagulants (for participants who will receive a lumbar puncture), strongly anticholinergic or sedative medications\n7. Use of anticonvulsant for seizure disorder. (Use of anticonvulsant to treat other illnesses will be reviewed by the study MD and eligibility will be determined on a case by case basis.)\n8. Current use of insulin\n9. Brain MRI contraindications; including use of pacemakers, aneurysm clips, artificial heart valves, ear implants or metal\u002Fforeign objects in the eyes will be excluded from MRI\n10. For participants completing any brain imaging protocol, inability to lie on the scanner bed for 40 minutes, or claustrophobia\n11. For ADCC-BIG, significant obesity or a lower back condition that is likely to impede successful collection of CSF, as determined by study physician judgment\n12. Other significant medical conditions at the investigators' discretion","55 Years",{"count":310,"type":19},850,"5 Years","Efforts to find treatments for AD have yielded only modest benefits, likely because longstanding AD pathological processes induce irreversible neurological compromise. These processes begin years before the onset of clinical symptoms. This possibility has been incorporated into a model describing stages of AD development, articulated by the NIA\u002FAlzheimer's Association preclinical workgroup of which the Co-Director of the Kulynych Alzheimer's Research Center, Dr. Suzanne Craft, was a member. According to this model, the best hope for countermanding the effects of AD lies in intervening at the earliest possible point in the pathological cascade. There are several important ongoing efforts in adults with preclinical AD that directly target amyloid aggregation. Although this strategy addresses an important aspect of the AD pathological cascade, we believe that addressing metabolic dysfunction affecting glucose and insulin regulation offers a complementary approach, in that it may reduce amyloid burden and toxicity, while also directly enhancing synaptic health, brain metabolism, tau regulation and neurovascular function.\n\nThe purpose of the ADCC is to identify and characterize early risk factors that predict cognitive decline and dementia in asymptomatic adults and adults with early signs of cognitive impairment. The data obtained from this study, collected at enrollment and follow-up will allow us to examine disease trajectory in individuals with and without prediabetes and other measures of glucoregulatory dysfunction in this process. The enrollees, who will be well-characterized with regard to cognitive and metabolic status through ADCC assessments, will provide an important resource for other local (institution) and national investigations. Data collected from participants enrolled in the ADCC will be stored indefinitely for future investigations.",[314,315,27],"Alzheimer's Disease","Mild Cognitive Impairment",[317,318,319,320],"Alzheimer's","observational","prediabetes","mild cognitive impairment","2026-03-26",{"date":323,"type":37},"2026-03-27",{"date":325,"type":37},"2014-01",{"date":327,"type":19},"2031-01",{"name":329,"class":44},"Wake Forest University Health Sciences",{"id":331,"slug":4,"hasResults":10,"nctId":332,"briefTitle":333,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":10,"sex":15,"minAge":53,"maxAge":106,"enrollmentInfo":335,"targetDuration":4,"studyType":20,"phases":337,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":45},"100558999","NCT06558422","Human Models of Selective Insulin Resistance: Pancreatic Clamp","Inclusion Criteria:\n\n* Men and women, ages 18-65 years\n* Body mass index of 27-50 kg\u002Fm2\n* Able to understand written and spoken English and\u002For Spanish\n* Evidence of insulin resistance, represented by any or all of the following criteria:\n\n  * Meeting either of the American Diabetes Association's definitions for prediabetes or Impaired fasting glucose (IFG) within the previous year and on screening labs:\n\n    1. Prediabetes: Hemoglobin A1c 5.7-6.4%\n    2. IFG: plasma glucose of 100-125 mg\u002FdL after 8-h fast\n* Homeostasis Model of Insulin Resistance (HOMA-IR) score ≥ 2.73\n* Fasting hyperinsulinemia (fasting insulin level ≥ 13 µU\u002FmL) on screening labs\n* Presence of uncomplicated MASLD, defined by vibration-controlled transient elastography (VCTE) as a steatosis score S1-S3 + fibrosis score F0-F2\n* Written informed consent (in English or Spanish) and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.\n\nExclusion Criteria:\n\n* Unable to provide informed consent in English or Spanish\n* Unwillingness to use only bedpan or urinal to void or to refrain from non-emergent mobile device use during the clamp\n* Documented weight loss of ≥ 5% of baseline within the previous 3 months\n* Abnormal blood pressure (including on treatment, if prescribed)\n\n  * Systolic blood pressure \\\u003C 90 mm Hg or \\> 160 mm Hg, and\u002For\n  * Diastolic blood pressure \\\u003C 60 mm Hg or \\> 100 mm Hg\n* Abnormal resting heart rate: \\\u003C 60 or ≥ 110 bpm\n\n  * Sinus brady- or tachycardia that has been worked up and considered benign by the recruit's personal physician may be permitted at the PI's discretion\n* Abnormal screening electrocardiogram (or if on file, performed within previous 90 days)\n* Laboratory evidence of diabetes mellitus:\n\n  * Hemoglobin A1c ≥ 6.5%, and\u002For\n  * Fasting plasma glucose ≥ 126 mg\u002FdL\n* Positive qualitative β-hCG (Human chorionic gonadotropin, β subunit) (i.e., pregnancy test) in women of childbearing potential\n* Positive urine drug screen, except for lawfully prescribed medications and\u002For marijuana\n* Liver function abnormalities (either of the following)\n\n  * Transaminases (AST or ALT) \\> 3.0 x the upper limit of normal\n  * Total bilirubin \\> 1.25 x the upper limit of normal\n* Fasting serum triglycerides at screening ≥ 400 mg\u002FdL\n* Abnormal screening serum electrolytes that are considered potentially significant according to the clinical judgment of the PI\n* Abnormal complete blood count (CBC) (any of the following)\n\n  * Hemoglobin \\\u003C 10 g\u002FdL or hematocrit \\\u003C 30%\n  * Platelet count \\\u003C 100,000\u002FµL\n* Women currently pregnant, measured by serum and\u002For urine β-hCG, or trying to become pregnant\n* Women currently breastfeeding\n* History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes):\n\n  * Hemoglobin A1c ≥ 6.5%, or rapid rise in documented HbA1c values causing clinical concern for evolving insulin deficiency\n  * Plasma glucose ≥ 126 mg\u002FdL after 8-h fast\n  * Plasma glucose of ≥ 200 mg\u002FdL at 2 h after ingestion of a 75-g glucose load\n  * Random plasma glucose ≥ 200 mg\u002FdL associated with typical hyperglycemic symptoms, diabetic ketoacidosis, or hyperglycemic-hyperosmolar state\n* History of gestational diabetes mellitus within the previous 5 years\n* Use of most antidiabetic medications within the 30 days prior to screening\n\n  * Excluded: thiazolidinediones, sulfonylureas, meglitinides, DPP4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, amylin mimetics, acarbose, insulin\n  * Metformin is acceptable provided that recruits meet all of the inclusion criteria at screening\n* Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)\n* Known diagnoses of familial combined hyperlipidemia or familial chylomicronemia syndrome\n* Use of certain lipid-lowering drugs within 30 d prior to screening visit:\n\n  * Fibrates (e.g., fenofibrate, clofibrate, gemfibrozil)\n  * Prescription-strength omega-3 fatty acids (e.g., Lovaza®, Vascepa®)\n* Known, documented history, at the time of screening, of any of the following medical conditions:\n\n  * Pancreatic pathology\n  * Cardiovascular diseases (N.B. uncomplicated hypertension is not exclusionary)\n  * Chronic kidney disease, Stage 3 or higher (estimated glomerular filtration rate \\\u003C 60 mL min-1 1.73 m-2), of any cause\n  * Advanced or severe liver disease (including fibrosis scores of F3-F4 on screening VCTE)\n  * Gallstone disease\n  * Chronic viral illness\n  * Malabsorptive conditions (active)\n  * Active seizure disorder (including controlled with antiepileptic drugs)\n  * Psychiatric diseases causing functional impairment and\u002For requiring use of anti-dopaminergic antipsychotic drugs associated with significant weight gain\u002Fmetabolic dysfunction (e.g., clozapine, olanzapine), monoamine oxidase inhibitors, tricyclic antidepressants, or lithium\n  * Known adrenal disease\n  * Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation\n  * Bleeding disorders, including due to anticoagulation, or significant anemia (see above)\n  * Active malignancy, or hormonally active benign neoplasm\n* Clinical concern for increased risk of volume overload, including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n* Clinical concern for increased risk of hypokalemia, including low potassium on screening labs (i.e., below lower limit of normal), use of certain medications, or any medical conditions listed above\n* Use of certain medications currently or within 30 d prior to screening:\n\n  * Prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 30 d prior to screening, except allowances for:\n  * Use of drugs prescribed for indications other than the exclusionary diagnoses\u002Fpurposes listed above, e.g., antiepileptic drugs used for non-seizure indications, ACEi (angiotensin-converting enzyme inhibitor) \u002F ARB (angiotensin receptor blocker) used for uncomplicated hypertension rather than for congestive heart failure, etc. Note, as above, that antidiabetic drugs except metformin within 30 days of screening are excluded.\n  * Loop diuretics (furosemide, torsemide, ethacrynic acid)\n  * Oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 30 days; topical and inhaled formulations are permitted\n  * Fludrocortisone\n  * Beta blockers or non-dihydropyridine calcium channel blockers (verapamil or diltiazem)\n* History of certain weight-loss (bariatric) surgery, including:\n\n  * Roux-en-Y gastric bypass\n  * Biliopancreatic diversion\n  * Restrictive procedures (lap band, sleeve gastrectomy) performed within the past 6 months\n* Clinical concern for alcohol overuse, including recent documented history during screening and\u002For participant report of regularly consuming more than 2 drinks per day for males or 1 drink per day for females.\n* Positive urine drug screen, with exceptions for:\n\n  * Lawfully prescribed medications\n  * Marijuana\u002FTHC positivity, provided that the participant agrees not to use it during the same period that they will abstain from alcohol\n* History of severe infection or ongoing febrile illness within 14 days of screening\n* Any other disease, condition, or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and\u002For interfere with the analysis of study data.\n* Known allergy\u002Fhypersensitivity to any component of the medicinal product formulations, foods (including soy, dairy, peanuts, tree nuts, or egg), IV infusion equipment, plastics, adhesive or silicone, history of infusion site reactions with IV administration of other medicines, or ongoing clinically important allergy\u002Fhypersensitivity as judged by the investigator.\n* Concurrent enrollment in another clinical study of any investigational drug therapy within 30 days prior to screening or within 5 half-lives of an investigational agent, whichever is longer.",{"count":336,"type":19},36,[262],"This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the impact of lowering insulin levels on hepatic glucose production (HGP) vs de novo lipogenesis (DNL) in people with insulin resistance. The investigators will recruit participants with a history of overweight\u002Fobesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and\u002For impaired fasting glucose and\u002For Homeostasis Model Assessment of Insulin Resistance \\[HOMA-IR\\] score \\>=2.73), and with evidence of metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo two pancreatic clamp procedures -- one in which serum insulin levels are maintained near hyperinsulinemic baseline (Maintenance Hyperinsulinemia or \"MH\" Protocol) and the other in which serum insulin levels are lowered by 50% (Reduction toward Euinsulinemia or \"RE\" Protocol). In both clamps the investigators will use stable-isotope tracers to monitor hepatic glucose and triglyceride metabolism. The primary outcome will be the impact of steady-state clamp insulinemia on HGP vs DNL.",[266,265,340,267,27,26],"Metabolic Dysfunction Associated Steatotic Liver Disease",[292,265,342,343,344],"Diabetes","Non-alcoholic fatty liver disease","Metabolic dysfunction associated steatotic liver disease","2026-02-04",{"date":347,"type":37},"2026-02-06",{"date":349,"type":19},"2027-01-01",{"date":351,"type":19},"2029-02-28",{"name":279,"class":44},{"id":354,"slug":4,"hasResults":10,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":10,"sex":15,"minAge":53,"maxAge":169,"enrollmentInfo":360,"targetDuration":4,"studyType":20,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":4},"100621936","NCT07377097","Effects of Sweetener Consumption on Risk Factors for Heart Disease in Prediabetic Subjects","Effects of Sweetener Consumption on Risk Factors for Heart Disease","Sweetheart","Inclusion Criteria:\n\n* Presence of prediabetes (HbA1c 5.7-6.4% or glucose after oral glucose tolerance test 140 to 199 mg\u002FdL)\n* Written informed consent available\n\nExclusion Criteria:\n\n* Inability to communicate sufficiently in the required language\n* Dementia or other significantly cognitively impairing condition\n* Current pregnancy or breastfeeding\n* Other severe internal, neurological, or psychiatric condition\n* History of gout\n* History of gallstones \u002F diagnosis of cholelithiasis",{"count":361,"type":19},80,[22],"The aim of this prospective interventional study is to investigate the metabolic effects of consuming artificial and natural sweeteners in persons with prediabetes. Prediabetes is a condition characterized by blood sugar levels that are elevated above normal but not yet meeting the criteria for type 2 diabetes. This condition markedly increases the risk of progressing to type 2 diabetes, which in turn can lead to complications including cardiovascular diseases.\n\nArtificial sweeteners such as saccharin and sucralose, as well as natural sugar substitutes like erythritol, are increasingly used as alternatives to sugar and are recommended for individuals at cardiometabolic risk - including overweight individuals, patients with prediabetes, or diabetics - to help reduce caloric intake. Recent literature has reported possible negative associations between artificial sweeteners and blood sugar regulation in healthy subjects (1). Additionally, effects on various blood cells have been observed. For example, erythritol has been shown to alter platelet function leading to increased reactivity in healthy study participants following consumption (2).\n\nHowever, the impact of alternative sweeteners on metabolic processes and their effects on blood coagulation in patients with prediabetes-a population at increased risk-has not been systematically studied. In this planned interventional study, 80 patients meeting laboratory criteria for prediabetes will be randomly assigned to one of four groups, each receiving a different intervention for two weeks: saccharin, sucralose, erythritol, or a control group receiving water. The doses reflect the acceptable daily intake or known doses that are considered safe.\n\nAfter enrollment, participants will visit the study center 2 times: before starting the intervention and after completing the intervention. During these visits, biological samples such as blood, urine, and stool will be collected to study metabolism, gut bacteria, immune and blood cell function. Tests will include an oral glucose tolerance test, coagulation tests, and additional blood analyses. Additionally, participants will wear a glucose monitor to track blood sugar fluctuations during the intervention.\n\nThe investigators hypothesize that consumption of alternative sweeteners negatively affects blood sugar regulation and insulin sensitivity in patients with prediabetes. Furthermore, this study will explore how the candidate sweeteners influence the gut microbiome, blood cells and other metabolic factors in this population.",[27,147,266,365,366,367,368,369,87,370,371],"Thrombosis","Hypercoagulable State","Cardiovascular (CV) Risk","Cardiovascular Risk Factors","Cardiovascular Diseases (CVD)","Prediabetes \u002F Type 2 Diabetes","Sweeteners","2026-01-22",{"date":374,"type":37},"2026-01-29",{"date":376,"type":19},"2026-01-05",{"date":378,"type":19},"2026-11-01",{"name":380,"class":44},"Charite University, Berlin, Germany",{"id":382,"slug":4,"hasResults":10,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":10,"sex":15,"minAge":53,"maxAge":387,"enrollmentInfo":388,"targetDuration":4,"studyType":20,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":45},"100585101","NCT06897982","Feasibility of a Nutrition Intervention for Patients With Prediabetes at a Federally Qualified Health Center","One-arm Feasibility and Acceptability Pilot Study of a Community-informed Nutrition Intervention to Recruit, Engage, and Retain Patients Who Are Eligible to Participate in the Diabetes Prevention Program at Two Community Health Centers in Los Angeles","Inclusion Criteria:\n\n* 18+ years old\n* BMI of 25 or higher (23 or higher if Asian)\n* Meet specific blood sugar test criteria indicating prediabetes, such as a fasting plasma glucose level between 110-125 mg\u002FdL or an A1C level between 5.7-6.4%\n* Not be diagnosed with type 1 or type 2 diabetes\n* Moderate to high risk of having prediabetes or a known diagnosis of prediabetes by their medical provider in the last 12 months.\n* Eligible or enrolled in the Diabetes Prevention Program\n\nExclusion Criteria:\n\n* Younger than 18 years of age\n* BMI of less than 25 or higher (or under 23 if Asian)\n* Does not meet specific blood sugar test criteria indicating prediabetes, such as a fasting plasma glucose level between 110-125 mg\u002FdL or an A1C level between 5.7-6.4%\n* Currently diagnosed with type 1 or type 2 diabetes\n* Has not been diagnosed as moderate to high risk of having prediabetes or having a known diagnosis of prediabetes by their medical provider in the last 12 months.","99 Years",{"count":389,"type":19},20,[22],"The purpose of the study is to assess the feasibility and acceptability of incorporating hands-on nutritional demonstrations to enhance the Diabetes Prevention Program (DPP) curriculum among patients who are at-risk for prediabetes",[27,393,394,395,396,397],"PreDiabetes","Health Knowledge, Attitudes, Practice","Nutrition, Healthy","Acceptability of Health Care","Obesity Prevention","2026-01-15",{"date":400,"type":37},"2026-01-20",{"date":402,"type":37},"2025-12-08",{"date":404,"type":19},"2027-02-28",{"name":406,"class":44},"Cedars-Sinai Medical Center",{"id":408,"slug":4,"hasResults":10,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":20,"phases":416,"briefSummary":417,"conditions":418,"keywords":430,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":45},"100620350","NCT07356479","Enhancing Mental and Physical Health of Women Veterans 3.0","Enhancing Mental and Physical Health of Women Through Engagement and Retention (EMPOWER) 3.0 (QUE 25-015)","EMPOWER","Inclusion Criteria:\n\n* This study is recruiting VA sites - not individual patients.\n* Prior to randomization, the study team will work with sites to ensure they have met the preconditions necessary to enroll in the study, which includes VISN, regional and\u002For facility level leadership support for participation.\n\nExclusion Criteria:\n\n* N\u002FA",{"count":415,"type":19},18,[22],"Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.",[419,112,26,420,421,422,27,423,424,425,426,427,428,429],"Cardiovascular Diseases","Hypertension","Cholesterol","Diabetes Mellitus","Menopause","Cognitive Behavioral Therapy","Primary Health Care","Stress Disorders, Post-Traumatic","Prevention","Implementation Science","Quality Improvement",[431,112,26,420,421,422,27,423,424,425,426,427,432,429,433,434,435,436,437,438,439,440],"Cardiovascular diseases","Implementation science","Women","Veterans","Patient Participation","Patient Satisfaction","Patient Preference","Physicians, Primary Care","Physicians, Women","Health Behavior","2026-01-12",{"date":443,"type":37},"2026-01-21",{"date":445,"type":19},"2026-10-01",{"date":447,"type":19},"2031-09-30",{"name":449,"class":450},"VA Office of Research and Development","FED",{"id":452,"slug":4,"hasResults":10,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":10,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":20,"phases":460,"briefSummary":461,"conditions":462,"keywords":465,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":478},"100279270","NCT02915198","Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes","CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)","VA-IMPACT","Inclusion Criteria:\n\n1. Pre-diabetes: This condition is fulfilled by HbA1c of at least 5.7%, but less than 6.5%; or two measurements of fasting plasma glucose (on separate days) of 100-125 mg\u002FdL; or a 2-hour plasma glucose level of 140-199 mg\u002FdL following a 75 g glucose load oral glucose tolerance test.\n2. Established atherosclerotic cardiovascular disease: Qualifying participants must have evidence of atherosclerotic disease in at least one of the following vascular beds: coronary, cerebrovascular, or peripheral arterial circulation.\n\nCoronary artery disease is fulfilled by at least one of (1), (2), or (3):\n\n1. History of myocardial infarction at least one month prior to randomization.\n2. History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization.\n3. Angiographic evidence of coronary stenosis of at least 50% in at least two major epicardial coronary arteries.\n\nCerebrovascular disease is fulfilled by at least one of criteria (1) through (4):\n\n1. Documented prior ischemic stroke (at least one month prior to randomization),\n2. Carotid artery stenosis 50% and history of transient ischemic attack or transient ischemic visual symptoms attributable to the identified lesion(s),\n3. Asymptomatic carotid stenosis of at least 70% luminal diameter,\n4. History of carotid revascularization (surgical or catheter-based).\n\nPeripheral arterial disease: Fulfilled by at least one of the following:\n\n1. History of aorto-iliac or peripheral artery intervention (surgical or catheter based) for limb ischemia, or amputation for limb ischemia,\n2. Symptoms of intermittent claudication with ankle:brachial index less than or equal to 0.85.\n\n3\\. Renal function: Estimated glomerular filtration rate at least 45 mL\u002Fmin\u002F1.73 m2.\n\n4\\. Informed consent has been fully executed, and participant agrees to study procedures.\n\nExclusion Criteria:\n\n1. Treatment with metformin or other anti-diabetic medication within 12 months of randomization. Note: In the absence of a diagnosis of diabetes, inpatient treatment with insulin or treatment with an SGLT2 inhibitor (e.g., for heart failure) or a GLP-1 receptor agonist (e.g., for obesity) is not exclusionary.\n2. Treatment with systemic glucocorticoids within 3 months of randomization\n3. Fasting plasma glucose greater than 130 mg\u002FdL measured between screening and randomization visits, or any plasma glucose 180 mg\u002FdL or HbA1c 7.0% measured within 12 months of randomization.\n4. Total CO2 below the local laboratory lower limit of normal on most recent blood chemistry panel\n5. Current treatment with cimetidine, vandetanib, or a systemic treatment with a carbonic anhydrase inhibitor.\n6. Cirrhosis, active hepatitis, or jaundice at time of randomization, or total bilirubin \\> 2 times upper limit of normal\n7. Binge or heavy alcohol consumption within 6 months of randomization\n8. Severe anemia (hemoglobin \\\u003C 10 g\u002FdL)\n9. Prior history of intolerance to metformin\n10. Myocardial infarction, coronary revascularization procedure, or stroke within 1 month of randomization\n11. Uncontrolled hypertension at screening assessment (systolic blood pressure 180 mm Hg or diastolic blood pressure 110 mm Hg\n12. Acute or decompensated congestive heart failure\n13. Expected survival less than study duration\n14. Participants considered to be unable, unwilling, or unreliable to meet protocol requirements\n15. Impaired decision-making capacity, defined by any history of dementia or cognitive impairment\n16. Concurrent participation in another research study involving a randomized comparison of drug or device treatments, unless specifically excepted.\n17. Pregnant, intent to become pregnant during the trial, or lactating\n18. Women of childbearing potential who are not using a highly effective method of contraception",{"count":459,"type":19},7410,[217],"This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and\u002For strokes in Veterans who have pre-diabetes and heart or blood vessel problems.",[27,463,464],"Atherosclerosis","Metformin",[464,463,27,466,467,468,469],"Hemoglobin A, Glycosylated","Coronary Artery Disease","Peripheral Arterial Disease","Cerebrovascular Disorders","2025-12-12",{"date":472,"type":37},"2025-12-17",{"date":474,"type":37},"2023-04-03",{"date":476,"type":19},"2029-09-28",{"name":449,"class":450},40,{"id":480,"slug":4,"hasResults":10,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":10,"sex":15,"minAge":485,"maxAge":486,"enrollmentInfo":487,"targetDuration":4,"studyType":20,"phases":489,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":45},"100521249","NCT06067139","Sleep for Health Study on the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk","Sleep for Health: A Randomized Clinical Trial Examining the Effects of Cognitive Behavioral Therapy for Insomnia on Diabetes Risk","Inclusion Criteria:\n\n* Age ≥ 22 years and \\\u003C 80 years of age\n* Prediabetes\n* Insomnia\n* Regular access to device with internet access\n* Adequate data at baseline\n\nExclusion Criteria:\n\n* BMI \\> 40 kg\u002Fm2\n* Sleep comorbidities detected in medical record or via medical history\n* Shift work or significant, externally imposed irregular sleep schedule\n* moderate to severe OSA by home sleep apnea test as part of trial protocol\n* Received a full course of CBT-I in the last 12 months\n* Current use of medication with glycemic effects:\n* History of type 1 or type 2 diabetes or recent\u002Fplanned use of hypoglycemic agents (e.g., metformin, insulin)\n* Recent history of bariatric surgery or planning bariatric surgery in the next year\n* Current or recent use of weight loss meds\n* Unstable sleep medication regimen (recent change to schedule or dosage)\n* Significant comorbidity that may interfere with CBT-I uptake or increase risks\n* Unwilling or unable to limit heavy machinery use\u002Flong bouts of driving or unstable illness that would be worsened by sleep restriction\n* High risk of falls\n* Epilepsy\n* Medical conditions that interfere with dCBT-I or contribute to insomnia or diabetes risk (e.g., hyperthyroidism, significant kidney disease, active cancer treatment, any medical condition that requires chronic steroid use)\n* Significant alcohol or substance use disorder\n* Active or recent history of eating disorder, recent weight change of \\>10%\n* Women: pregnancy (current or planned), breastfeeding, \\\u003C 1 year postpartum\n* Use of hydroxyurea\n* Extensive skin changes or adhesive allergy making CGM sensor use problematic","22 Years","79 Years",{"count":488,"type":19},300,[22],"This study tests whether providing cognitive behavioral therapy for insomnia (CBT-I) to people with prediabetes results in a reduction in glucose levels compared to a patient education control program.",[25,27,492],"Sleep Initiation and Maintenance Disorders","2025-12-11",{"date":495,"type":37},"2025-12-15",{"date":497,"type":37},"2023-08-01",{"date":499,"type":19},"2027-12",{"name":501,"class":44},"Kaiser Permanente",{"id":503,"slug":4,"hasResults":10,"nctId":504,"briefTitle":505,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":193,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":20,"phases":510,"briefSummary":511,"conditions":512,"keywords":517,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":45},"100569172","NCT06690788","PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes","PT2T","Inclusion Criteria:\n\n1. \"Target partner\" is eligible for the National DPP per CDC eligibility requirements:\n\n   * BMI ≥ 25 kg\u002Fm² (≥ 23 kg\u002Fm² if Asian American), and\n   * Do not have a diagnosis of type 1 or type 2 diabetes, and\n   * Not currently pregnant, and\n   * High risk for type 2 diabetes based on: (i) CDC Prediabetes Risk Test score ≥ 5, (ii) clinically diagnosed Gestational Diabetes during a previous pregnancy (for women), or (iii) a blood test result indicative of prediabetes in the past year (i.e., fasting blood glucose 100-125 mg\u002Fdl; plasma glucose 140-199 mg\u002Fdl measured 2 hours after a 75 g glucose load; or HbA1c 5.7%-6.4%).\n2. The couple has lived together for 1+ years.\n3. Both partners are willing to participate in the research.\n4. Both partners are at least 18 years old.\n5. Both partners are fluent in English.\n\nEXCLUSION CRITERIA:\n\n1. \"Supporting partner\" has a diagnosis of Type 2 Diabetes.\n2. Either partner:\n\n   * Has a diagnosis of another chronic disease (unless no major events\u002Fchanges for 3+ months), or\n   * Is currently on medication or engaged in lifestyle intervention for prediabetes or obesity, or\n   * Has previously participated in the National DPP, or\n   * Reports discomfort participating in a lifestyle program with their partner, or\n   * Reports a low level of relationship commitment (i.e., \"4\" or lower on a scale from 1 (do not agree at all) to 7 (agree completely) on the item \"I want this relationship to stay strong no matter what rough times we encounter.\"; Owen et al., 2011).",{"count":509,"type":19},324,[22],"Nearly half of adults in the United States have or are at risk of developing type 2 diabetes. The overall goal of this community-engaged research is to examine the efficacy of an innovative couple-based lifestyle intervention to prevent type 2 diabetes that is applicable to a broad range of partnered adults in the United States. By simultaneously targeting lifestyle and perceived support from romantic partners, there is a high likelihood of creating lasting changes in both",[27,513,514,515,516,26],"Life Style","Intervention Study","Social Support","Physical Activity",[518,427,515,519],"Lifestyle Intervention","Couple Relationships","2025-05-28",{"date":522,"type":37},"2025-05-30",{"date":524,"type":37},"2025-03-06",{"date":526,"type":19},"2028-11",{"name":528,"class":44},"University of Utah",{"id":530,"slug":4,"hasResults":10,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":193,"sex":15,"minAge":53,"maxAge":106,"enrollmentInfo":536,"targetDuration":4,"studyType":20,"phases":538,"briefSummary":539,"conditions":540,"keywords":541,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":45},"100465449","NCT05340868","Genetics of the Acute Response to Oral Semaglutide","Genetics of the Acute Response to Oral Semaglutide (GAROS)","GAROS","Inclusion Criteria:\n\n* Informed consent was given before any study-related action on the subject.\n* Age: 18-65 years old\n* Body mass index (BMI) \\>30 kg\u002Fm2 or \\>27 kg\u002Fm2 when accompanied by prediabetes, diagnosed according to the criteria of the American Diabetes Association\n\nExclusion Criteria:\n\n* Patients diagnosed with a serious chronic disease, including:\n\n  * Ischemic heart disease\n  * Heart failure (NYHA class III-IV)\n  * Severe renal insufficiency (eGFR \\\u003C30 ml\u002Fmin)\n  * Severe liver diseases\n  * Inflammatory bowel disease\n  * Diabetic gastroparesis\n  * Cancer - currently or in the last five years prior to screening\n  * Chronic obstructive pulmonary disease\n  * History of mental illness, major depression or other severe mental disorders\n* Use of any medications with clinically-proven significant weight gain or loss effects\n* History of undergoing bariatric surgery or other surgery involving the stomach that could affect the absorption of the study drug (according to the investigator's opinion)\n* History of idiopathic acute pancreatitis\n* A family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid cancer\n* For women - pregnancy, breastfeeding or planning pregnancy.\n* Women of childbearing age who are not using highly effective methods of contraception\n* Known or suspected hypersensitivity to the test product",{"count":537,"type":19},1000,[22],"The study aims to investigate the genetic basis of the response to short-term (3 months) orally administered semaglutide treatment, in terms of improving metabolic parameters, including the hormonal response to a standardized meal, and changes in body composition and liver steatosis. In the study, parameters such as fasting and 2-hour glucose during OGTT, HbA1c, body fat mass, body weight, total cholesterol, HDL and LDL, triglycerides, HOMA-IR, Matsuda Index and liver steatosis will be assessed. All the patients will undergo genome-wide genotyping. Moreover, in a subset of participants, muscle and fat biopsies will be performed, before and after the treatment, and liver, muscle and pancreas fat content will be assessed using MRI.",[393,27,26],[542,543,319,544],"pharmacogenetics","semaglutide","obesity","2025-03-21",{"date":547,"type":37},"2025-03-26",{"date":549,"type":37},"2022-09-01",{"date":551,"type":19},"2025-12-31",{"name":553,"class":44},"Medical University of Bialystok",{"id":555,"slug":4,"hasResults":10,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":10,"sex":15,"minAge":561,"maxAge":285,"enrollmentInfo":562,"targetDuration":4,"studyType":20,"phases":564,"briefSummary":565,"conditions":566,"keywords":568,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":580,"locationsCount":45},"100571717","NCT06723886","Antidiabetic Effect of Olive Pomace Oil","Assessment of the Potential Antidiabetic Effects of Olive Pomace Oil in Diabetic or Prediabetic Subjects: Postprandial Study and Chronic Intervention","OPODIABE","Inclusion Criteria:\n\n* Fasting blood glucose between 100-126 mg\u002FdL and\u002For\n* Glycated haemoglobin (HbA1c) between 5.7-6.4% and\u002For\n* Diabetic persons with Fasting blood glucose \\>126 mg\u002FdL and\u002For\n* Diabetic persons with Glycated haemoglobin (HbA1c) \\> 6.4%\n\nExclusion Criteria:\n\n* Kidney or liver diseases\n* Gastrointestinal diseases (irritable bowel syndrome, Crohn disease, chronic bowel inflammation)\n* Food allergies\u002Fintolerances\n* Vegetarians\u002Fvegans\n* Smoking\n* Pregnant or lactating women\n* On prescription drugs other than for hypertension\u002Fthyroid\u002Fdyslipidemia\u002Fglucose control, or changes in dosage in the last 3 months\n* Consumption of vitamins, dietary supplements or nutraceuticals","20 Years",{"count":563,"type":19},50,[22],"This clinical trial aims at assessing whether consumption of olive pomace oil in the diet may benefit persons with type 2 diabetes mellitus or persons at risk of developing the disease (prediabetic persons).\n\nThe main questions the study aims to answer are:\n\n* May olive pomace oil prevent a high increase of blood glucose levels when consumed in a meal together with carbohydrates in diabetic\u002Fprediabetic patients?\n* May olive pomace oil decrease fasting blood glucose levels of diabetic\u002Fprediabetic patients after consuming it daily?\n* May daily consumption of olive pomace oil improve glucose homeostasis and other alterations like elevated blood lipids or inflammation, which also affect persons with diabetes or prediabetes?\n\nResearchers will compare the effect of consuming olive pomace oil to the effects of a comparison oil (high-oleic acid sunflower oil).\n\nParticipants will:\n\nIn different days, they will consume white bread alone or the oils (olive pomace oil, high-oleic acid sunflower oil or extra virgin olive oil) spread on white bread and blood will be collected at different times during 2 h. This study to observe the increase of blood glucose after a carbohydrate-rich breakfast will be part of the so-called \"postprandial\" study, and will be conducted during 3 weeks, during which participants will consume corn oil on a daily basis.\n\nParticipants will also take part in the \"chronic\" study, that will last 22 weeks in total. During this study, they will firstly \"wash\" the effects of the oil they normally consume in their diets by consuming corn oil during 3 weeks. It is during these weeks when they will attend the Human Nutrition Unit (HNU) of ICTAN to carry on the \"postprandial\" study described in the previous paragraph.\n\nAfter the initial 3 weeks, participants will consume olive pomace oil as the only oil in their diets during 8 weeks, \"wash\" its effects again by consuming corn oil during 3 weeks and then change to consume the other oil (high-oleic acid sunflower oil) during 8 weeks.\n\nDuring the chronic study, they will visit the clinic once every 4 weeks for checkups and tests. They will refrain from eating other oils or specific fat-rich foods. Participants will also attend our phone calls to ask them what they ate the day before on different weeks during the study, and wear an accelerometer during 1 week to record their physical activity. They will keep a diary of the doses of insulin\u002Fmetformin used and the blood glucose levels they measured at home.",[149,567,27,342,422],"Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)",[569,342,87,570,571,572,573],"Olive pomace oil","Antidiabetic effect","Postprandial study","Chronic intervention","High-oleic acid sunflower oil","2024-12-06",{"date":576,"type":37},"2024-12-11",{"date":578,"type":19},"2025-01-15",{"date":36,"type":19},{"name":581,"class":132},"Instituto de Ciencia y Tecnología de Alimentos y Nutrición",{"id":583,"slug":4,"hasResults":10,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":10,"sex":15,"minAge":53,"maxAge":213,"enrollmentInfo":588,"targetDuration":4,"studyType":20,"phases":590,"briefSummary":591,"conditions":592,"keywords":594,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":45},"100553048","NCT06481020","Plant Sterols on Cardiovascular Markers, Microbiota and Sterol Metabolism (Cardiofoodsterol)","Effect of Plant Sterols on Inflammatory, Endothelial Function and Oxidative Stress Markers, Microbiota and Sterol Metabolism in a Cardiovascular Risk Population","Inclusion Criteria:\n\n* BMI: 27-29.9 or 30-39.9\n* Plasmatic glucose: \\\u003C 100mg\u002Fdl or 100-125mg\u002Fdl\n* Glycosylated hemoglobin: \\\u003C 5.7 or 5.7-6.4\n* LDL cholesterol \\> 115mg\u002FdL\n* Serum levels of biochemical and hematological parameters and fat-soluble vitamins within reference ranges.\n\nExclusion Criteria:\n\n* Subjects on cholesterol-lowering pharmacological treatment\n* Smokers\n* Alcohol consumption above 30 g\u002Fday\n* Pregnant or lactating women\n* Any infection, serious illness or co-morbidity that may affect the bioavailability of PS (e.g., malabsorption, celiac disease, allergies or food intolerances)\n* Diseases of the gastrointestinal tract\n* Antibiotic, hormonal or anabolic treatment\n* Participants consuming foods enriched with PS or food supplements that contain PS\n* Participants who follow specialist weight loss diets, vegans or vegetarians",{"count":589,"type":19},42,[22],"Potential cholesterol-lowering effect of a regular intake of a plant sterol (PS)-containing food supplement, in overweight\u002Fobese type 1 or 2, normoglycemic\u002Fpre-diabetic, with LDL-cholesterol values \\> 115 mg\u002Fdl and not pharmacologically treated participants treated with the PS-containing food supplement or placebo supplement.",[419,593,27,146],"Hypercholesterolemia",[595,596,597,598,599,600,601,602,603,516],"Cholesterol LDL","Plant Sterols","Inflammation","Oxidative Stress","Microbiota","Sterol Metabolites","Endothelial function","Bioimpedance","Dietary Intake","2024-06-26",{"date":606,"type":37},"2024-07-01",{"date":608,"type":37},"2024-05-21",{"date":610,"type":19},"2025-02",{"name":612,"class":44},"University of Valencia",{"id":614,"slug":4,"hasResults":10,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":10,"sex":15,"minAge":53,"maxAge":106,"enrollmentInfo":619,"targetDuration":4,"studyType":20,"phases":621,"briefSummary":622,"conditions":623,"keywords":625,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":638,"locationsCount":563},"100550519","NCT06448130","Henagliflozin's Impact on Prediabetes Remission","Effect of Henagliflozin on the Remission of Prediabetes Population: A National Multicenter, Randomized Controlled Study","Inclusion Criteria:\n\n1. Male or female subjects between the ages of 18 and 65 years;\n2. Individuals without hypoglycemic therapy before, including hypoglycemic drugs or traditional Chinese medicine formulations with hypoglycemic effects;\n3. Prediabetic patients as defined by Expert Consensus on Intervention for Prediabetes in Chinese Adults, 2023 Edition:1)Fasting plasma glucose (FPG) between 6.1 and 7.0 mmol\u002FL and\u002For 2-hour postprandial glucose (2h-PPG) between 7.8 and 11.1 mmol\u002FL; 2)And\u002For HbA1c between 5.7% and 6.5%;\n4. Individuals willing to provide written informed consent and can comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n1. Allergic to Henagliflozin;\n2. Previously diagnosed with diabetes;\n3. HbA1c ≥ 6.5% or FPG ≥ 7.0 mmol\u002FL or PPG ≥ 11.1 mmol\u002FL;\n4. Use of GLP-1 receptor agonists, orlistat, or other weight-reducing drugs in the past 3 months;\n5. Fluctuation in weight by 5% or more in the past month;\n6. Use of drugs affecting glucose synthesis, absorption, or metabolism, such as glucocorticoids (e.g., prednisone, dexamethasone), contraceptives, growth hormone, hormonal replacement therapy (estrogen and progesterone), immunosuppressants (e.g., cyclosporine A, tacrolimus), anti-tuberculosis drugs (e.g., isoniazid, rifampicin);\n7. Untreated hyperthyroidism or hypothyroidism, excluding those with normal thyroid function after treatment;\n8. Persistently uncontrolled hypertension (used antihypertensive drugs but was not effectively controlled in the 3 months prior to enrollment) or currently use 3 or more antihypertensive drugs (including diuretics);\n9. Assessed by the investigator to be at high risk of genitourinary system infections, such as history of recurrent urinary tract infections or reproductive system infections, long-term placement of urinary catheters, or history of urological surgery;\n10. Other obesity caused by endocrine disorders, such as Cushing's syndrome;\n11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \\> 3 times of the upper limit of the normal range (UNL);\n12. eGFR less than 30 mL\u002Fmin\u002F1.73 m2, severe kidney damage, end-stage renal disease or requiring dialysis;\n13. Significant cardiovascular diseases including myocardial infarction, congestive heart failure (≥grade III New York Heart Association), left ventricular ejection fraction≤40%, or cerebrovascular accidents;\n14. Impaired consciousness and various mental health disorders;\n15. Malignant tumors and other serious illnesses;\n16. Pregnant or breast-feeding or planning pregnancy within 24 months;\n17. Enrolled in another clinical trial currently or within the 3 months prior to enrollment;\n18. Identified by the investigator that lacks sufficient motivation to continue the long-term clinical trial (e.g., out-of-town study, work plan, need to care for family members), or considered prefer to withdraw from the trial for non-medical reasons (such as social issues).",{"count":620,"type":19},984,[217],"This clinical trial evaluates the effectiveness of Henagliflozin combined with lifestyle interventions for managing patients with prediabetes. As global prediabetes rates rise, increasing the risk of diabetes and vascular issues, addressing treatment gaps is essential. Henagliflozin, a novel SGLT2 inhibitor developed in China, aims to improve glucose control and metabolic health when paired with lifestyle changes.\n\nThe study's primary objectives include: assessing whether Henagliflozin can achieve normoglycemia in prediabetic patients after 6 months of treatment.\n\nThe trial will compare three groups (Henagliflozin 5mg, 10mg, and a placebo), focusing on efficacy and safety. Participants, assigned randomly, will undergo a 6-month treatment phase and an 18-month follow-up. Regular health assessments will monitor glucose levels, metabolic health, and risks of major complications like cardiovascular events and microvascular diseases, with additional evaluations of C-peptide and insulin changes.\n\nStructured as a multicenter, randomized, double-blind, placebo-controlled study, it involves 984 prediabetic adults across 50 medical institutions in China. This comprehensive approach could redefine prediabetes management by integrating drug therapy with lifestyle modifications.",[393,27,31,624],"Glucose Metabolism Disorders",[626,627,628,629,630,624,631],"Prediabetes management","Henagliflozin","SGLT2 inhibitors","Lifestyle interventions","Type 2 diabetes prevention","Metabolic Diseases","2024-06-03",{"date":634,"type":37},"2024-06-07",{"date":636,"type":19},"2024-06",{"date":499,"type":19},{"name":639,"class":132},"Shandong Provincial Hospital",{"id":641,"slug":4,"hasResults":10,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":645,"eligibilityCriteria":646,"healthyVolunteers":10,"sex":15,"minAge":53,"maxAge":4,"enrollmentInfo":647,"targetDuration":4,"studyType":20,"phases":649,"briefSummary":650,"conditions":651,"keywords":652,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":660,"completionDateStruct":661,"leadSponsor":663,"locationsCount":45},"100513247","NCT05962983","Small Steps for Big Changes - Recipe for Health","A Recipe for Health: Evaluating the Effectiveness of a Diabetes Prevention Program on Dietary Behaviours and Diabetes Risk","RFH","Inclusion Criteria:\n\n* adults over the age of 18 and able to read and speak English\n* living with prediabetes: HbA1c% values between 5.7-6.4% (American Diabetes Association, 2012), or\n* individuals diagnosed with type 2 diabetes in remission, defined as achieving HbA1c of \\\u003C 6.4% without any diabetes-related medications for a minimum of 3 months (Diabetes Canada Clinical Practice Guidelines, 2022), or\n* individuals at high risk of developing type 2 diabetes defined as an American Diabetes Association risk questionnaire score ≥ 5.\n\nExclusion Criteria:\n\n* failure to obtain participant's signed declaration for the Get Active questionnaire\n* currently diagnosed with type 2 diabetes with an HbA1c of 6.5% or greater\n* pregnant",{"count":648,"type":19},250,[22],"The purpose of this study is to evaluate changes in HbA1c levels, diet, weight and waist circumference in Small Steps for Big Changes (SSBC) diabetes prevention program participants two year after program completion compared to before they took part in the program.\n\nThe main questions it aims to answer are:\n\n1. Are changes in caloric, carbohydrate, and fibre intake associated with HbA1c levels after SSBC program completion in the short (3- and 6- months), medium (9- and 12- months) and long-term (21- and 24- months)?\n2. Are changes in caloric, carbohydrate, and fibre intake associated with anthropometrics (weight and waist circumference) after program completion in the short (3- and 6- months), medium (9- and 12- months) and long-term (21- and 24- months)?\n3. Are eating motives associated with dietary intake in individuals with prediabetes?\n4. Does participation in SSBC result in changes to eating motives over time?\n\nIt is hypothesized that:\n\n1. Dietary changes will be associated with HbA1c levels at 3-, 6-,12- and 24- months post-intervention.\n2. Dietary changes will be associated with weight and waist circumference at 3-, 6-, and 12-months post-intervention.\n3. Participants' eating motives are associated with their dietary intake.\n4. Eating motives will change after partaking in SSBC and at 3-, 6-, 12- months post intervention.\n\nA total number of 250 individuals with prediabetes will be recruited to take part in a 6-week diet and exercise changes program (SSBC). The program will be administered and facilitated by the community facility trainers at YMCA locations. Participants will be asked to visit Diabetes Prevention Research Group (DPRG) Lab in the University of British Columbia Okanagan Campus for Hba1c (primary outcome), anthropometric measurements and dietary assessment.",[393,27],[653,654,655,656],"dietary assessment","type 2 diabetes","diabetes prevention","behaviour change","2023-07-24",{"date":659,"type":37},"2023-07-27",{"date":497,"type":19},{"date":662,"type":19},"2026-08-01",{"name":664,"class":44},"University of British Columbia",""]