[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-syndrome-mets\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-syndrome-mets":408},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,46,70,100,127,152,173,193,214,238,264,297,314,335,369],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100644979",false,"NCT07675122","Duodenal-jejunal Bypass Sleeve (DJBS) for Obesity and Metabolic Syndrome","Endoscopic Duodenal-jejunal Bypass Sleeve for Treatment of Obesity and Metabolic Syndrome - a Multicenter Pilot Study","DJBS-OMS","Inclusion Criteria:\n\n* Body mass index (BMI) ≥27.5kg\u002Fm2; or BMI ≥25 kg\u002Fm2 with metabolic syndrome\n\nExclusion Criteria:\n\n* Patients who have lost more than 5 kg of weight in the past three months\n* Patients who have used glucagon-like peptide-1 receptor agonists (GLP-1RAs) in the past three months\n* Patients who are currently taking weight loss drugs such as orlistat\n* Those who have taken antiplatelet drugs or anticoagulant drugs such as aspirin in the past month\n* iron deficiency or iron deficiency anemia\n* Gastrointestinal malformations, such as patients with gastrointestinal atresia or other patients who will cause gastrointestinal implantation failure\n* Those with a history of cholecystitis and liver abscess\n* There is a known infection, and the type of disease and the severity of the infection are not suitable for use by clinicians\n* coagulation dysfunction;\n* Severe liver and kidney dysfunction, AST \u002FALT \\> 2.5 times, total bilirubin \\> 35 μmol\u002FL, blood creatinine concentration greater than 180 μmol\u002FL\n* Patients with ASA IV \\& V\n* Drug or alcohol abuse addiction or suffering from uncontrollable mental illness\n* Duodenal bulb ulcer, gastric ulcer or previous and existing pancreatitis\n* Coronary heart disease, angina, cardiac function grade III or above, or pulmonary dysfunction\n* Patients who have undergone ERCP before\n* Patients with potential bleeding or telangiectasia in the stomach, esophagus, small intestine and other parts\n* Have a history of systemic lupus erythematosus, scleroderma\n* Those who have contraindications to endoscopy (judged by clinicians)\n* Pregnant women or those who are preparing to become pregnant\n* Those who are allergic to nickel-titanium\n* Any other situation that the clinician deems unsuitable for participation in this product","ALL","18 Years","65 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is designed to evaluate the efficacy, safety, and mechanisms of duodenal-jejunal bypass sleeve in patients with obesity",[27,28],"Obesity","Metabolic Syndrome (MetS)",[30,31,32],"duodenal-jejunal bypass sleeve","DJBS","DJBL","NOT_YET_RECRUITING","2026-06-25",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":21},"2026-08-01",{"date":41,"type":21},"2029-07-31",{"name":43,"class":44},"Chinese University of Hong Kong","OTHER",2,{"id":47,"slug":4,"hasResults":10,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100622961","NCT07390422","Duodenal pulsENDO for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease","Duodenal Recellularization Via Electroporation Therapy for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease (DRESS-1 Study)","DRESS-1","Inclusion Criteria:\n\n* Duration of T2DM \\\u003C 10 years\n* BMI 18.5-40kg\u002Fm2\n* Failure to achieve adequate HbA1c reduction (7.5 - 11%) after at least 3 months stable dosage of oral glucose lowering drugs\n\nExclusion Criteria:\n\n* Previous treatment with pulsENDO or similar procedure\n* Previous GI surgery that could preclude the ability to perform pulsENDO, or acute gastric and duodenal pathology that increased the risk of pulsENDO\n* Type 1 DM, DM secondary to specific disease or having any history of ketoacidosis\n* Patients on insulin\n* Fasting C-peptide level \\\u003C0.5ug\u002FL\n* Any inflammatory disease of the gastrointestinal tract such as Crohn's disease\n* Abnormal pathologies or conditions of the gastrointestinal tract, including duodenal polyps, ulcers or upper gastrointestinal bleeding conditions within 3 months of study\n* Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000\u002Fmicroliter or known coagulopathy\n* Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to study and\u002For there is a need or expected need to use during the study period\n* Currently taking medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)\n* Patients who have used non-steroidal analgesics and anti-inflammatory drugs (NSAID) and corticosteroids in the past 1 month\n* Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyroidism, Cushing syndrome and eating disorder.\n* Patients with contra-indications to endoscopy\n* Patients with cirrhosis due to causes other than MASLD\n* Malignancy\n* Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)\n* Pregnant or breast feeding\n* ASA grade IV \\& V\n* Mental or psychiatric disorder; Drug or alcohol addiction\n* Other cases deemed by the examining physician as unsuitable for safe treatment\n* Refusal to participate","70 Years",{"count":55,"type":21},40,[24],"This study is designed to evaluate the efficacy, safety, and mechanisms of pulsENDO procedure in patients with T2DM and its effect on MASLD.",[59,60,28],"T2DM (Type 2 Diabetes Mellitus)","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","2026-06-20",{"date":63,"type":37},"2026-06-24",{"date":65,"type":21},"2026-09-01",{"date":67,"type":21},"2033-08-30",{"name":43,"class":44},1,{"id":71,"slug":4,"hasResults":10,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":69},"100642371","NCT07659444","Metformin Withdrawal In Metabolic Syndrome","Effects of 14-Day Metformin Withdrawal on OGTT-Derived Insulin Sensitivity in Adults With Metabolic Syndrome: A Randomized Controlled Trial","METMS","Inclusion Criteria:\n\n* Currently treated with metformin as part of their usual medical care for at least 12 months before enrolment.\n* Diagnosis of metabolic syndrome according to established clinical criteria, based on the presence of at least three of the following components: increased waist circumference, elevated triglycerides, reduced HDL cholesterol, elevated blood pressure or antihypertensive treatment, and elevated fasting glucose or treatment for dysglycemia.\n* Stable metformin dose for at least 3 months before enrolment.\n* Willing and medically able to temporarily discontinue metformin for 14 days if assigned to the metformin discontinuation group.\n* Able and willing to undergo repeated oral glucose tolerance tests, venous catheter placement, repeated blood sampling, indirect calorimetry measurements, blood pressure measurements, and heart rate measurements.\n* willing to wear a continuous glucose monitoring device during the study period.\n* Preserved kidney function at baseline, defined as estimated glomerular filtration rate ≥60 mL\u002Fmin\u002F1.75 m² and urine albumin-to-creatinine ratio \\\u003C30 mg\u002Fg, or values considered clinically acceptable by the study physician.\n* No previous history of clinically significant diabetes-related complications, including diabetic retinopathy, diabetic foot disease, severe peripheral neuropathy, or diabetic kidney disease.\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes.\n* Current treatment with insulin or other glucose-lowering medications.\n* Previous history of severe hypoglycemia, diabetic ketoacidosis, hyperosmolar hyperglycemic state, or other acute diabetes-related metabolic complications.\n* Uncontrolled diabetes or clinically unsafe glycemic status at screening, defined as HbA1c above 8.0 %, fasting plasma glucose above 160 mg\u002Fdl, or any other glycemic value considered unsafe by the study physician.\n* Known allergy or intolerance to materials used in the continuous glucose monitoring device, adhesive patches, venous catheter, or study procedures.",{"count":78,"type":21},28,[24],"The goal of this clinical trial is to investigate how a short-term interruption of metformin treatment affects insulin sensitivity, glucose control, and metabolic flexibility in adults with metabolic syndrome who are taking metformin as part of their usual medical treatment. Temporary interruptions in metformin treatment may occur in real-life situations, such as missed doses, medication access problems, travel, or planned short-term discontinuation for clinical reasons. This study aims to understand whether stopping metformin for 14 days leads to rapid changes in glucose metabolism or whether the effects of previous metformin treatment may persist during a short period without the medication.\n\nThe main questions it aims to answer are:\n\nDoes stopping metformin for 14 days worsen glucose control or insulin sensitivity measured by oral glucose tolerance tests, HbA1c, and continuous glucose monitoring?\n\nDoes stopping metformin for 14 days affect metabolic flexibility, measured by indirect calorimetry during the oral glucose tolerance test?\n\nDoes stopping metformin for 14 days affect blood lipids, liver and inflammatory markers, red blood cell parameters, kidney function markers, fasting lactate levels, blood pressure, or heart rate?\n\nResearchers will compare participants who stop metformin for 14 days with participants who continue their usual metformin treatment to see whether temporary metformin discontinuation affects insulin sensitivity, glucose control, metabolic flexibility, and other cardiometabolic markers.\n\nParticipants in the metformin discontinuation group will stop taking metformin for 14 days. They will attend study visits on day 0, day 4, day 7, and day 14. At each visit, they will complete an oral glucose tolerance test, have blood samples taken, and undergo indirect calorimetry measurements before and after the glucose drink. Blood pressure and heart rate will also be measured during the test. Participants will wear a continuous glucose monitor throughout the 14-day period to track glucose levels and help detect any potentially unsafe increase in blood glucose.\n\nParticipants in the usual-treatment group will continue taking metformin as prescribed. They will attend study visits on day 0 and day 14. At each visit, they will complete an oral glucose tolerance test, have blood samples taken, and undergo indirect calorimetry, blood pressure, and heart rate measurements during the test.\n\nAt the study visits, researchers will assess glucose and insulin responses, HbA1c, continuous glucose monitoring data, metabolic flexibility, blood lipid profile, liver and inflammatory markers, red blood cell parameters, kidney function markers, fasting lactate levels, blood pressure, and heart rate.",[28,82],"Glucose Intolerance",[84,85,86,87,88,89],"MetS","Metabolic Syndrome","Metformin","Insulin Sensitivity","Metabolic Flexibility","OGTT","RECRUITING","2026-06-16",{"date":93,"type":37},"2026-06-22",{"date":95,"type":37},"2026-04-05",{"date":97,"type":21},"2026-08-30",{"name":99,"class":44},"University of Castilla-La Mancha",{"id":101,"slug":4,"hasResults":10,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":69},"100613688","NCT07269847","Comparing a Healthy Beef-Centric Diet to a Healthy U.S.-Style Diet on Metabolic Health Outcomes in Pre-Diabetic Adults","A Randomized Study to Compare the Effect of a Healthy Beef-Centric Diet to a Healthy U.S.-Style Dietary Pattern on Inflammation and Other Metabolic Health Outcomes in a Metabolic Syndrome and\u002For Pre-Diabetic Population","Inclusion Criteria:\n\n* Participant must be 18 - 74 years of age (inclusive) at the time of signing the informed consent.\n* Have a BMI range of 23.0 - 39.9 kg\u002Fm2 (inclusive).\n* In otherwise generally good health as determined by the investigator.\n* Have blood hs-CRP levels equal to or greater than 2.0 mg\u002FL at screening.\n* Have the following conditions at screening:\n\n  1. Pre-diabetes (defined as an HbA1c of 5.7-6.4% \\[inclusive\\]), and\u002For\n  2. MetS, i.e., have 3 of the 5 following metabolic criteria:\n\n     * A waist circumference of more than 40 inches (102 cm) in men and 35 inches (88 cm) in women\n     * Serum triglycerides level of 150 mg\u002FdL (1.7 mmol\u002FL) or greater\n     * Reduced HDL cholesterol, less than 40 mg\u002FdL (1.0 mmol\u002FL) in men or less than 50 mg\u002FdL (1.3 mmol\u002FL) in women\n     * Elevated fasting glucose of 100 mg\u002FdL (5.6 mmol\u002FL) or greater\n     * Blood pressure values of systolic 130 mmHg or higher or diastolic 85 mmHg or higher\n* Report low to moderate levels of physical activity, as defined by a \"low\" or \"moderate\" activity classification on the IPAQ-SF (if ≤69 YOA) or IPAQ-E (if ≥70 YOA) at screening.\n* Consume meat-based protein as a part of their normal diet and regularly consume beef.\n* Not currently using, defined as ≤ 3 uses in the past 3 months prior to Visit 2, any nicotine containing products (patches, gums, vapes, etc.), and willing to abstain for 14 days before Visit 2 until the last procedure.\n* Have maintained a stable, self-reported body weight for at least 6 months prior to screening (maximum ±10% change in self-reported body weight).\n* Willing and able to consume all aspects of either study dietary intervention.\n* Willing to adhere to all study dietary intervention prohibitions and restrictions.\n* Have maintained consistent dietary habits, including medication and supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study (unless required per the restrictions).\n* Agree to follow the restrictions on concomitant treatments.\n* Agree to follow the restrictions on lifestyle.\n* Agree to avoid pregnancy throughout the study if of childbearing potential by using any preferred contraceptive method.\n* Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.\n\nExclusion Criteria:\n\n* Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test at Visit 2.\n* Have a known sensitivity, intolerability, or allergy to any of the components of the study dietary interventions and\u002For CGM sensor.\n* Have followed and maintained a ketogenic, Mediterranean, low-carbohydrate, vegetarian, vegan or any other special diet in the 3 months prior to screening.\n* Have been diagnosed with Type I or II diabetes or thyroid disease.\n* Have blood pressure of ≥ 160 systolic or ≥ 100 diastolic mmHg.\n* Have a history or current diagnosis of eating disorders such as anorexia or bulimia.\n* Have current symptoms, or symptoms within the past 7 days, of an acute infection (e.g., fever, respiratory symptoms such as persistent cough or difficulty breathing), that may influence study outcomes as assessed by the investigator.\n* Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of protein, fat, or micronutrients (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).\n* Have a history of gallbladder disease (e.g., cholelithiasis, cholecystitis), cholecystectomy, gout, or kidney stones.\n* Have a history of heart\u002Fcardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment\u002Fdisease, immune disorders and\u002For immunocompromised (i.e., HIV\u002FAIDS).\n* Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) with recovery occurring within 5 years before the screening visit.\n* Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).\n* Major surgery in 3 months prior to screening or planned major surgery during the study.\n* Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such an in-patient or out-patient intervention program) or use that in the opinion of the investigator may be a concern for the study.\n* Current enrollment or past participation in another study with either any product(s) with at least one active ingredient or a dietary intervention, within 28 days before screening or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.\n* Living in the same household as another currently enrolled participant in the present study.\n* Any other medical condition\u002Fsituation or use of medications\u002Fsupplements\u002Ftherapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.","74 Years",{"count":108,"type":21},56,[24],"This randomized study will be conducted to compare the effect of a healthy beef-centric diet to a healthy U.S.-style dietary pattern on inflammation and other metabolic health outcomes in a metabolic syndrome and\u002For pre-diabetic population.",[28,112,113],"Inflammation","Pre-Diabetes",[115,116,112,85,113],"Healthy Beef-Centric Diet","Healthy U.S.-Style Dietary Pattern","2026-04-28",{"date":119,"type":37},"2026-05-04",{"date":121,"type":37},"2026-02-10",{"date":123,"type":21},"2026-09-03",{"name":125,"class":126},"National Cattlemen's Beef Association, a contractor to the Beef Checkoff","INDUSTRY",{"id":128,"slug":4,"hasResults":10,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":141,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":148,"leadSponsor":150,"locationsCount":69},"100592363","NCT06992453","Multi-omics Dissection of Gut Microbiome Engraftment During FMT","Disentangling Microbiome Engraftment by Multi-omics of the Gut Ecosystem During Fecal Transplant","DissEcT","Inclusion Criteria:\n\nCoorte: Patients affected by Ulcerative Colitis\n\n* Age ≥18 years.\n* UC with mild-to-moderate activity (total Mayo score 3-10 + endoscopic subscore≥1) (23)\n* UC during stable maintenance therapy (\\> 8 weeks with salicylates, immunosuppressants);\n* Ability to give informed consent.\n\nCoorte: Patients affected by metabolic syndrome\n\n* Age ≥18 years.\n* Patients with MetS (high glycaemia levels (\\> 100 mg\u002FdL), hypertension (\\> 130\u002F85 mmHg), raised triglyceride levels (\\> 150 mg\u002FdL), low high-density lipoprotein cholesterol levels (\\\u003C 40 mg\u002FdL in men; \\\u003C50 mg\u002FdL in women), and abdominal obesity (waist circumference of \\> 102 cm in men; \\>88 cm in women)\n* Stable treatment (\\> 8 weeks) of one of these disorders, included in MetS definition.\n* Ability to give informed consent\n\nCoorte: Patients affected by rCDI\n\n* Age ≥18 years\n* Mild recurrent Clostridioides difficile infection (26)\n* Ability to give informed consent.\n\nExclusion criteria\n\n* Pregnancy, breastfeeding, and the refusal to follow an effective contraception method for all the study duration (for women).\n* Known active gastrointestinal disorders (e.g. infectious gastroenteritis except CDI, coeliac disease, irritable bowel syndrome, chronic pancreatitis, biliary salt diarrhoea) apart from UC, with clinical characteristics reports in inclusion criteria.\n* Antimicrobial treatment up to 4 weeks prior to screening visit (apart for patients with rCDI)\n* Previous colorectal surgery or cutaneous stoma\n* Critical and severe comorbidities\n* Inability to give informed consent.",{"count":135,"type":21},90,[24],"The gut microbiota plays a key role in immunity and metabolism and contributes to diseases such as recurrent C. difficile infection (rCDI), ulcerative colitis (UC), and metabolic syndrome (MetS). Microbiota therapeutics, particularly fecal microbiota transplantation (FMT), show promise-achieving \\~90% cure rates in rCDI-but demonstrate variable efficacy in chronic conditions. Microbiome engraftment appears critical for FMT success, yet consistent predictors remain lacking. A meta-analysis of 20 FMT studies by our group and the Segata Lab linked engraftment to clinical response across diseases, with taxon-specific patterns and ML-based predictability. While viral, fungal, host immune, genetic, and metabolic factors may affect engraftment, their roles are not well-defined. Key unresolved questions include the interplay among host factors, microbial strains, and metabolites, their influence on engraftment, and impact on clinical outcomes. This study aims to unravel microbiome engraftment dynamics and link them to therapeutic response.",[139,140,28],"Recurrent C. Difficile (rCDI)","Ulcerative Colitis (UC)",[142,143,144],"Microbiome engraftment","Gut ecosystem","Fecal microbiota transplantation","2026-04-23",{"date":117,"type":37},{"date":145,"type":21},{"date":149,"type":21},"2029-02-19",{"name":151,"class":44},"Catholic University of the Sacred Heart",{"id":153,"slug":4,"hasResults":10,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":159,"targetDuration":4,"studyType":160,"phases":4,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":69},"100588827","NCT06946472","Impact of Metabolic Syndrome on Rehabilitation Outcomes in Rotator Cuff Injury","Investigating the Impact of Metabolic Syndrome on Pain, Muscle Strength, Kinesthesia, and Functionality in Rotator Cuff Injury Rehabilitation","RMY-METS","* Inclusion Criteria for the Non-MetS Group:\n\n  * Aged between 18-65 years\n  * Willing to participate in the study\n  * Unilateral Rotator Cuff Tear (RMY)\n* Inclusion Criteria for the MetS Group:\n\nIn addition to the above criteria, meeting at least three of the NCEP-ATP III consensus criteria for Metabolic Syndrome Stable metabolic syndrome (e.g., no significant medical changes in the last 3 months)\n\n\\- Exclusion Criteria for All Participants:\n\n* Inability to cooperate with the tests or presence of mental health issues\n* Presence of cervical radiculopathy symptoms\n* Presence of other orthopedic pathologies in the same shoulder (e.g., fracture, prosthesis, avascular necrosis, advanced shoulder osteoarthritis, frozen shoulder, severe scapular dyskinesia, neurological diseases, etc.)\n* Presence of function-limiting neurological, vascular, or cardiac issues\n* Local steroid injection to the shoulder within the last 3 months\n* Receipt of physiotherapy or rehabilitation within the last 3 months\n* Systemic rheumatic or inflammatory diseases\n* Surgical history due to chronic rotator cuff tear\n* Diagnosis of glenohumeral joint or acromioclavicular joint arthritis\n* Severe scapular dysfunction or significant postural abnormalities",{"count":55,"type":21},"OBSERVATIONAL","This prospective comparative study aims to investigate the effect of Metabolic Syndrome (MetS) on the outcomes of a standardized rehabilitation program in patients with Rotator Cuff Injuries (RCI). Patients diagnosed with RCI will be divided into two groups based on the presence or absence of MetS, determined by NCEP-ATP III criteria. Both groups will receive the same 4-week physiotherapy protocol including hot pack, TENS, ultrasound, and therapeutic exercises. Pain intensity, pain threshold, muscle strength, kinesthesia, and shoulder functionality will be evaluated before and after treatment. The study hypothesizes that the presence of MetS negatively affects rehabilitation outcomes in patients with RCI by altering inflammation and tissue healing processes.",[163,28],"Rotator Cuff Injury (RCI)","2026-04-18",{"date":166,"type":37},"2026-04-21",{"date":168,"type":21},"2026-07-15",{"date":170,"type":21},"2026-12-05",{"name":172,"class":44},"Elif Dilara Durmaz",{"id":174,"slug":4,"hasResults":10,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":178,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":69},"100633963","NCT07533513","Effects and Mechanisms of Dietary Carbohydrate Intake and Quality on Glucose and Lipid Metabolism","Inclusion Criteria:\n\n* Male and female aged 18 - 65 years;\n* BMI 20 - 35 kg\u002Fm2;\n* Consent to be randomly assigned to an intervention or control group;\n* Willingness to eat the food and beverages provided in the study;\n* Patients with or at high risk of metabolic syndrome, and the diagnostic criteria of metabolic syndrome were based on the Chinese Guidelines for the Prevention and Treatment of diabetes (2024 edition).\n\nExclusion Criteria:\n\n* Use of medications that affect blood glucose metabolism;\n* Familial hyperlipidemia, or use of drugs that affect lipid metabolism;\n* Long-term or current use of nonsteroidal anti-inflammatory drugs, antibiotics, antihistamines, or immunomodulatory drugs, and unable to stop taking these drugs within 72 h before the start of the study;\n* Use of hormonal medications such as anticoagulants, anabolic steroids, and hydrocortisone;\n* Have a history of serious illness, or are in the acute stage of cardiovascular, renal, thyroid, gastrointestinal, hepatobiliary, immunologic, respiratory, neurological, musculoskeletal, psychiatric, infectious, and malignant diseases, and are receiving treatment or use of related drugs;\n* Self-reported weight gain or loss of more than 7 kg in the 6 months before enrollment;\n* Vegetarian;\n* Have food allergies or other problems that may affect food intake;\n* Unable to consume only the food and beverages provided in the study;\n* Drink alcohol more than 2 times per day, more than 14 times per week, and unwillingness to stop drinking during the study;\n* Participate in a weight-loss program;\n* Unwillingness to maintain weight throughout the study;\n* Females who have given birth within the past year, are pregnant or plan to become pregnant within 6 months, are breastfeeding;\n* Intend to participate in other dietary intervention studies and drug use studies in the next 4 months;\n* Poor venous blood access;\n* Any other that the physician assessed as unsuitable for the trial conditions.",true,{"count":20,"type":21},[24],"This study aimed to explore the effects of quantity and quality of dietary carbohydrate intakes on glucose and lipid levels and metabolism, as well as gut microbiota by a randomized crossover controlled intervention trial.",[28,183],"Metabolic Syndrome Risk Factors","2026-04-09",{"date":186,"type":37},"2026-04-16",{"date":188,"type":21},"2026-04-13",{"date":190,"type":21},"2028-03-30",{"name":192,"class":44},"Sun Yat-sen University",{"id":194,"slug":4,"hasResults":10,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":10,"sex":16,"minAge":199,"maxAge":18,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":69},"100624491","NCT07410325","Effectiveness and Implementation of a Community-based Health Coach-led Artificial Intelligence (AI)-Powered Digital Self-Regulation Program for Individuals With Metabolic Syndrome (MetS)","LIGHTER-MetS","Inclusion Criteria:\n\n1. are between 21 to 65 years of age;\n2. have a waist circumference ≥90 cm in men and ≥80 cm in women;\n3. have 2 or more of the following to be classified as having metabolic syndrome:\n\n   * triglyceride level of ≥1.7 mmol\u002FL or on specific treatment for this lipid abnormality;\n   * high density lipoprotein (HDL) cholesterol \\\u003C1.03 mmol\u002FL in men, and \\\u003C1.29 mmol\u002FL in women, or on specific treatment for this lipid abnormality;\n   * blood pressure of ≥130\u002F85 mmHg or on treatment of previously diagnosed hypertension;\n   * fasting blood glucose level of ≥ 5.6 mmol\u002FL or previously diagnosed type 2 diabetes;\n4. are not receiving other structured lifestyle modification programs;\n5. consent to audio-recording;\n6. English speaking and literate.\n\nExclusion Criteria:\n\n1. underwent or are scheduled for metabolic surgery within 1 year;\n2. are pregnant or planning for pregnancy at the time of recruitment;\n3. are unable to speak English;\n4. do not own a smartphone; and\n5. are unable to provide informed consent.","21 Years",{"count":201,"type":21},316,[24],"This study aims to evaluate the effectiveness of the Lifestyle Intervention for Gentle, Healthy Transformation and Enhanced Weight Reduction-metabolic syndrome (LIGHTER-MetS) program on dietary self-regulation and cardiovascular risk among individuals with metabolic syndrome (MetS). The LIGHTER-MetS program, a community-based, grassroots-led initiative, integrates health coaching with the eTRIP© app to promote sustainable lifestyle changes focusing on diet, exercise, and emotion regulation.",[28,85],"2026-04-07",{"date":207,"type":37},"2026-04-08",{"date":209,"type":37},"2026-01-01",{"date":211,"type":21},"2027-01",{"name":213,"class":44},"National University Health System, Singapore",{"id":215,"slug":4,"hasResults":10,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":20},"100609824","NCT07219602","A Study to Evaluate the Effect of Obicetrapib\u002FEzetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and\u002For Metabolic Syndrome","A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and\u002For Metabolic Syndrome (RUBENS Trial)","RUBENS","Inclusion Criteria:\n\n* fasting serum LDL-C ≥ 70 mg\u002FdL (≥1.81 mmol\u002FL)\n* Have fasting TG ≥150 mg\u002FdL (≥1.7 mmol\u002FL) and \\\u003C400 mg\u002FdL (\\\u003C4.5 mmol\u002FL)\n* Know diagnosis of T2DM OR have metabolic syndrome defined as fasting TG ≥150 mg\u002FdL (≥1.7mmol\u002FL) and \\\u003C400 mg\u002FdL (\\\u003C4.5 mmol\u002FL) and at least 2 risk factors\n* Are on stable guideline-recommended lipid-lowering therapy\n* Estimated glomerular filtration rate ≥15 mL\u002Fmin\u002F1.73 m2\n\nExclusion Criteria:\n\n* Have current or any previous history of New York Heart Association class III or IV heart failure or left ventricular ejection fraction \\\u003C30%\n* Have been hospitalized for heart failure within 5 years prior to Screening\n* Have uncontrolled severe hypertension\n* Have a formal diagnosis of homozygous familial hypercholesterolemia\n* HbA1c ≥10.0% (≥0.100 hemoglobin fraction) or a fasting glucose ≥270 mg\u002FdL (≥15.0 mmol\u002FL) at Screening\n* active liver disease",{"count":222,"type":21},300,[224],"PHASE3","This study will be a placebo-controlled, double-blind, randomized, Phase 3 study to evaluate the efficacy, safety, and tolerability of obicetrapib 10 mg, both as a fixed-dose combination (FDC) with ezetimibe 10 mg and as monotherapy, on top of guideline-recommended lipid-lowering therapy in patients with metabolic syndrome and\u002For Type 2 Diabetes Mellitus.",[227,228,28],"Lipidemia","Type 2 Diabetes (T2DM)","2026-03-06",{"date":231,"type":37},"2026-03-10",{"date":233,"type":37},"2025-12-11",{"date":235,"type":21},"2028-06",{"name":237,"class":126},"NewAmsterdam Pharma",{"id":239,"slug":4,"hasResults":10,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":244,"targetDuration":246,"studyType":160,"phases":4,"briefSummary":247,"conditions":248,"keywords":251,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":69},"100628474","NCT07462104","Metabolic Syndrome Associated Diet","Pro-İnflammatory Diet as a Modifying Factor in Periodontal Tissue Destruction Associated With Metabolic Syndrome","Inclusion Criteria:\n\n* Being between 18 and 65 years of age\n* Presence of at least three of the following parameters: (For MetS diagnosis) Waist circumference: ≥ 94 cm for men, ≥ 88 cm for women Blood pressure ≥ 130\u002F85 mmHg or taking antihypertensive medication Fasting blood glucose ≥ 100 mg\u002Fdl or diagnosed with Type 2 Diabetes Triglycerides ≥ 1.7 mmol\u002FL HDL \\\u003C 1.29 mmol\u002FL\n* Having at least 20 teeth\n* Not having received periodontal therapy in the last 6 months\n* Not having taken antibiotics, steroids, and\u002For nonsteroidal anti-inflammatory drugs in the last 3 weeks\n* Not having any autoimmune disease, osteoporosis, or cancer\n* Not taking immunosuppressive medications, oral contraceptives, Not taking bisphosphonates\n* Not being pregnant\n* Not having an active infectious disease (acute hepatitis, tuberculosis, AIDS)\n* Not taking chronic medications that affect periodontal tissues (cyclosporine A, phenytoin)\n* Not taking antioxidant supplements in the last 6 months\n\nExclusion Criteria:\n\n* Patients with an active infectious disease,\n* Those taking medications that could affect periodontal tissues,\n* History of endocarditis,\n* Recent antibiotic use (within 4 months),\n* Alcohol\u002Fdrug use,\n* Psychological disorders,\n* Eating disorders,\n* Dementia,\n* Pregnancy and breastfeeding,\n* Patients who did not sign the informed consent form",{"count":245,"type":21},100,"1 Day","The goal of this observational study is to examine the relationship between metabolic syndrome (MetS) and periodontitis, and to evaluate the role of the Dietary Inflammatory Index (DII) in this association.\n\nThe main question it aims to answer is:\n\nDoes a pro-inflammatory diet, as measured by the DII, increase the risk or severity of periodontitis in individuals with metabolic syndrome?\n\nParticipants will include adults who meet the diagnostic criteria for metabolic syndrome. Their periodontal health will be assessed through standard clinical parameters, and dietary data will be collected using a validated food frequency questionnaire to calculate individual DII scores. The study will observe and analyze these factors to explore potential links between diet-induced inflammation, systemic metabolic health, and periodontal outcomes.",[28,249,250],"Periodontitis","Diet, Food and Nutrition",[252,253,254,255],"metabolic syndrome","periodontitis","diet","inflammation","2026-03-04",{"date":231,"type":37},{"date":259,"type":21},"2026-03-23",{"date":261,"type":21},"2026-11-23",{"name":263,"class":44},"Recep Tayyip Erdogan University Training and Research Hospital",{"id":265,"slug":4,"hasResults":10,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":178,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":278,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":69},"100625710","NCT07426172","Role of Elevated Lactate Levels on Lipid and Carbohydrate Metabolism.","LACTMET","Inclusion Criteria:\n\n* Men and women\n* \\>18 years of age\n* Women non-pregnant or taking contraceptive medication\n* Physically active according to WHO's guidelines\n* Metabolic syndrome as IDF 2009 criteria (Alberti et al., Circulation)\n* Written and verbal consent to participation\n\nExclusion Criteria:\n\n* Chronic illness that prevents them from exercising\n* Affected blood samples at screening, as assessed by the PI\n* Assessed as unsuitable by PI",{"count":271,"type":21},24,[24],"The purpose of this study is to investigate whether the elevated circulating lactate levels of individuals with metabolic syndrome are responsible for their reduced lipolysis and glucose tolerance. The investigators will conduct an intervention study in which blood lactate levels will be elevated via intravenous infusion of sodium lactate. State of the art metabolic assessment using stable isotopes and indirect calorimetry will be used to study alterations in fat and carbohydrate metabolism.",[275,28,276,277],"Hyperlactatemia","Lipolysis","Exercise",[279,280,281,282,283,284,285,286,287,252],"blood lactate","lipolysis","oral glucose tolerance test","stable isotopes","indirect calorimetry","carbohydrate oxidation","fat oxidation","exercise","metabolic flexibility","2026-02-15",{"date":290,"type":37},"2026-02-23",{"date":292,"type":37},"2026-01-20",{"date":294,"type":21},"2028-09-30",{"name":296,"class":44},"Ricardo Mora",{"id":298,"slug":4,"hasResults":10,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":303,"targetDuration":246,"studyType":160,"phases":4,"briefSummary":304,"conditions":305,"keywords":306,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":312,"leadSponsor":313,"locationsCount":69},"100620222","NCT07354815","Metabolic Syndrome-Associated Periodontal Inflammatory Surface Area","Determination of the Level of Correlation Between Periodontal Inflammatory Surface Area and Metabolic Syndrome-Associated Periodontal Tissue Destruction","Inclusion Criteria:\n\n* Being between 18 and 65 years of age\n* Presence of at least three of the following parameters: (For MetS diagnosis) Waist circumference: ≥ 94 cm for men, ≥ 88 cm for women Blood pressure ≥ 130\u002F85 mmHg or taking antihypertensive medication Fasting blood glucose ≥ 100 mg\u002Fdl or diagnosed with Type 2 Diabetes Triglycerides ≥ 1.7 mmol\u002FL HDL \\\u003C 1.29 mmol\u002FL\n* Having at least 20 teeth\n* Not having received periodontal therapy in the last 6 months\n* Not having taken antibiotics, steroids, and\u002For nonsteroidal anti-inflammatory drugs in the last 3 weeks\n* Not having any autoimmune disease, osteoporosis, or cancer\n* Not taking immunosuppressive medications, oral contraceptives, Not taking bisphosphonates\n* Not being pregnant\n* Not having an active infectious disease (acute hepatitis, tuberculosis, AIDS)\n* Not taking chronic medications that affect periodontal tissues (cyclosporine A, phenytoin)\n* Not taking antioxidant supplements in the last 6 months\n\nExclusion Criteria:\n\n* Patients with active infectious disease,\n* Those taking medications that may affect periodontal tissues,\n* Those who did not sign the informed consent form.",{"count":245,"type":21},"This study aims to examine the potential of metabolic syndrome (MetS), a systemic, inflammatory disease, to influence the relationship between periodontal inflammatory surface area (PISA) and diabetes and obesity parameters. The primary question addressed by the study is:\n\nCan PISA be used as a significant parameter in the relationship between periodontal disease and MetS? In this context, the relationship between PISA and periodontal clinical parameters and serum parameters directly related to the diagnosis of MetS will be examined.",[28,249],[252,253,307],"periodontal inflammatory surface area","2026-01-12",{"date":310,"type":37},"2026-01-21",{"date":290,"type":21},{"date":36,"type":21},{"name":263,"class":44},{"id":315,"slug":4,"hasResults":10,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":322,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":334},"100600331","NCT07096102","Efficacy of a Health Empowerment Theory Based Health Information Literacy Promotion Intervention in Individuals With Metabolic Syndrome","Inclusion Criteria:\n\n* Age ≥ 18 years old and ≤ 75 years old;；\n* Patients diagnosed with metabolic syndrome (meeting ≥3 criteria):\n* Waist circumference ≥ 90 cm (men) \u002F ≥ 85 cm (women)\n* Fasting glucose ≥ 6.1 mmol\u002FL or OGTT 2h-glucose ≥ 7.8 mmol\u002FL and\u002For diabetes treatment\n* Blood pressure ≥ 130\u002F85 mmHg and\u002For hypertension treatment\n* Fasting triglycerides (TG) ≥ 1.70 mmol\u002FL\n* Fasting HDL-C \\\u003C 1.04 mmol\u002FL；\n* Aware of the condition, have basic reading and language communication skills, and voluntarily participate in this study\n\nExclusion Criteria:\n\n* Patients with severe liver and kidney dysfunction, cancer, severe cardiovascular and cerebrovascular diseases, gout, etc., which seriously endanger life, have abnormal nutritional status and require special diet;\n* Pregnant patients；\n* Patients with a history of mental illness and cognitive impairment；\n* Those currently participating in other research projects.","75 Years",{"count":321,"type":21},310,[24],"The ENRICH study is aimed to Enpower patieNts with metabolic syndrome (Mets) to increase their Risk perception and to acquire health Information necessary for Capability building and promotion of Health information literacy, as well as health outcomes. The purpose of this clinical trial is to evaluate the efficacy of this health information literacy promotion intervention based on Health Empowerment Theory in individuals with metabolic syndrome. The study aims to answer the following questions:\n\nDoes the intervention improve health information literacy among study participants? Does the intervention lead to better health outcomes, including weight, waist circumference, BMI control, and metabolic health indicators (blood pressure, blood glucose, glycated hemoglobin, and blood lipids)?\n\nParticipants will:\n\nUndergo the intervention program for 6 weeks (face to face and online) and will be assessed regularly to monitor changes in terms of their level of health information literacy and health outcomes.",[28],"2025-11-24",{"date":327,"type":37},"2025-12-01",{"date":329,"type":37},"2025-08-31",{"date":331,"type":21},"2026-12-30",{"name":333,"class":44},"Meihua Ji",4,{"id":336,"slug":4,"hasResults":10,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":10,"sex":16,"minAge":341,"maxAge":4,"enrollmentInfo":342,"targetDuration":344,"studyType":160,"phases":4,"briefSummary":345,"conditions":346,"keywords":352,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":69},"100612037","NCT07248371","Validating Integrative Multi-omics Approaches in Metabolic Syndrome-related Diseases","Validating Integrative Multi-omics Approaches in Metabolic Syndrome-related Diseases: A Step Towards Precision Medicine","Inclusion Criteria:\n\n* Individuals (male or female) aged 20 years or older\n* Willing and able to provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients with end-stage renal disease receiving hemodialysis or peritoneal dialysis\n* Individuals currently undergoing active cancer treatment\n* Recipients of any organ transplantation\n* Patients diagnosed with dementia","20 Years",{"count":343,"type":21},6266,"5 Years","This study aims to validate integrative multi-omics approaches for understanding complications related to metabolic syndrome. By combining genetic, transcriptomic, metabolomic, and microbiome data from participants with and without metabolic syndrome, the research seeks to determine which biological factors predict disease progression and how these insights can inform precision prevention and treatment strategies for metabolic disorders.",[28,347,348,349,350,351],"Obesity & Overweight","Cardiovascular Diseases (CVD)","Chronic Kidney Disease","Nonalcoholic Fatty Liver Disease","Healthy",[85,353,354,355,356,357,358,359],"Multi-Omics","Precision Medicine","Metabolomics","Genomics","Transcriptomics","Microbiome","Machine Learning","2025-11-18",{"date":362,"type":37},"2025-11-25",{"date":364,"type":37},"2025-06-09",{"date":366,"type":21},"2035-09-30",{"name":368,"class":44},"Chang Gung Memorial Hospital",{"id":370,"slug":4,"hasResults":10,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":178,"sex":16,"minAge":376,"maxAge":53,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":389,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":69},"100599548","NCT07085923","Norwegian Mental Illness Heart Health Study","Dietary Counselling And Exercise To Combat Cardiovascular Disease Risk In Norwegian Patients With A Severe Mental Illness","NORMI-Heart","Inclusion Criteria:\n\n* Diagnosis of F20-29 (schizophrenia spectrum) or F31 (bipolar affective disorder)\n* Current use of antipsychotic medication (first- or second generation) or lithium\n* Body Mass Index \\> or = 27 kg\u002Fm\\^2\n\nExclusion Criteria:\n\nPsychiatric condition:\n\n* Inability to provide informed consent\\*\n* Acute psychiatric crisis\\*\n* Significant cognitive impairment\\* \\*These criteria will be evaluated and confirmed by the participant's primary mental health care provider before enrollment\n\nMedication initiated during the intervention period:\n\n* GLP-1 receptor agonists\n* Antihypertensive medication\n* Antidiabetic medication\n* Lipid-lowering medication\n\nAlcohol consumption:\n\n-More than 14 units per week (men) or more than 7 units per week (women)\n\nSomatic conditions:\n\n* Type 1 diabetes\n* Established cardiovascular disease\n* Body Mass Index (BMI) \\\u003C27 kg\u002Fm²\n* Pregnancy\n* Inability to perform physical exercise\n\nSomatic risk findings at baseline:\n\n* HbA1c \\>57 mmol\u002Fmol (7.4%)\n* LDL cholesterol \\>5.0 mmol\u002FL\n* Blood pressure \\>180\u002F100 mmHg\n* Active malignant disease","25 Years",{"count":378,"type":21},70,[24],"Norwegian patients with severe mental illnesses (SMI), such as schizophrenia spectrum or bipolar disorder, lose on average 10 years of life compared to mentally healthy individuals. Much of this gap is due to heart disease. Unhealthy lifestyle habits, including poor diet and physical inactivity, contribute to higher levels of metabolic risk factors for heart disease in this population.\n\nThe goal of this clinical trial is to find out if a lifestyle program including dietary counselling and regular physical exercise can help people with SMI to improve their physical and mental health.\n\nThe main questions it aims to answer are:\n\n* Does adherence to a healthy lifestyle program lead to reduced estimated risk of heart disease?\n* Does it change lifestyle habits, body weight and composition, and metabolic risk markers over six months?\n* Can participants with severe mental illness complete a healthy lifestyle program, and do they find it acceptable?\n\nResearchers will compare two groups: one that receives the lifestyle program in addition to regular mental health care, and one that receives regular care only.\n\nDuring the six month program, participants in the lifestyle group will:\n\n* Meet with a clinical dietitian once a month for dietary counselling\n* Take part in group-based physical activity sessions once a month, and receive support to follow a personal training plan\n\nAround 70 adults will take part in the study. The results may help improve the way lifestyle support is offered to people living with severe mental illness and inform health care providers about strategies to improve physical health in this vulnerable group.",[382,28,383,384,385,386,387,388],"Cardio Vascular Disease","Severe Mental Disorder","Schizophrenia and Schizophrenia Spectrum Psychosis","Bipolar Disease Type I","Overweight and\u002For Obesity","CVD Risk Factors","Severe Mental Illness",[388,390,391,392,277,393,394,395,396,397,398],"Cardiovascular Disease","Lifestyle Intervention","Healthy Diet","CVD-risk","Schizophrenia","Antipsychotic Medication","Bipolar Disorder","Non-pharmacological intervention","Clinical Dietitian","2025-09-26",{"date":401,"type":37},"2025-10-02",{"date":403,"type":37},"2025-09-16",{"date":405,"type":21},"2028-06-30",{"name":407,"class":44},"Madeleine Elisabeth Angelsen",""]