[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-disease":656},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,67,0,25,[9,44,70,81,110,133,160,180,229,260,281,305,325,334,356,379,410,431,462,485,504,527,556,598,630],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053897",false,"NCT06007404","Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents","The Role of Circulating Meta-Inflammatory Monocytes in Adolescent Insulin Resistance","Inclusion Criteria:\n\n* Between 14 and 18 years of age\n* Tanner stage 4 or 5 (mature adult stage of puberty)\n* Normal weight (BMI ≥ 5th percentile \\& \\\u003C 85th percentile), overweight (BMI \\> 86th percentile) \\& \\\u003C 94th percentile), obese weight (BMI percentile ≥ 95th percentile), and\u002For pre-diabetes (HbA1c \\> 5.7%)\n* For Type 2 Diabetes cohort, diagnosis of Type 2 Diabetes\n\nExclusion Criteria:\n\n* Currently pregnant\n* Use medications known to affect glucose metabolism (immunosuppressive medications, cancer medications, or high dose steroids), unless prescribed for Type 2 Diabetes management\n* Prior diagnosis of autoimmune disease, cancer, or a cognitive or perceptual disability that would inhibit following directions of study staff\n* Allergies or intolerance to milk, soy, or palm oil",true,"ALL","14 Years","18 Years",{"count":21,"type":22},175,"ESTIMATED","OBSERVATIONAL","This research study collects health-related information and blood samples to better understand how body composition, lifestyle habits, and diet influence meta-inflammatory monocytes (MiMos) in adolescents. The hypothesis of this study is that adolescents at risk for metabolic disease have enhanced MiMo related activities leading to insulin resistance.",[26,27,28,29,30],"Type 2 Diabetes","Insulin Resistance","Obesity","Metabolic Disease","PreDiabetes","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2023-09-06",{"date":39,"type":22},"2027-09",{"name":41,"class":42},"University of Michigan","OTHER",1,{"id":45,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":16,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100054286","NCT02890342","Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia","The Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia","* INCLUSION CRITERIA:\n* Patients 2 years of age or older, of any gender and ethnicity, with propionic acidemia are eligible to enroll in this protocol. Patients diagnosis will be confirmed based on biochemical and\u002For molecular and enzymatic testing. Participants of any gender and ethnicity over 1 month of age are eligible to enroll remotely for collection of outside records and natural history data. They will be eligible to enroll in the full study for in-person evaluation at 2 years of age.\n* Unaffected family members over 1 month of age, of any ethnicity or race, may be included in the study as household controls for microbiome studies and\u002For for genetic analysis. Studies in unaffected family members may include collection of medical and family history; if necessary completion of physical examination; drawing of blood for research purposes include testing of DNA; collection of stool samples for microbiome studies; collection of dietary history using pen-and-paper or electronic food diary and questionnaires; collection of saliva for metabolite and DNA analysis. In some unaffected family members without a known familial cause of propionic acidemia, exome sequencing or genome sequencing could be performed. Unaffected family members will not receive direct benefit from taking part in the study.\n* If a participant becomes pregnant while on study, the participant can remain on study. The only way to learn more about the critical biological differences in those who affected with propionic acidemia who are pregnant is to continue to follow pregnant women on study.\n\nHowever, no tests or procedures that are greater then minimal risk will be performed. Affected subjects who are pregnant may undergo procedures as part of their clinical care, including blood draws, genetic studies, and consultations, according to the clinical judgement of the clinical team. However, pregnant participants will be excluded from procedures such as organ tissue collection, stable isotope studies, GFR testing, and brain or cardiac MRI until the pregnancy is concluded.\n\n* Healthy volunteers may be eligible to participate in the study if they are between 12 - 40 years of age, must meet specific BMI criteria (similar to affected individuals studied).\n* Patients with propionic acidemia over 1 month of age, of any gender and ethnicity, undergoing a transplantation surgery at Children s Hospital of Pittsburgh, are eligible to participate in the tissue collection arm of the study.\n\nEXCLUSION CRITERIA:\n\n* The PI\u002FAI may decline to enroll a patient because of poor metabolic control, lack of a primary metabolic\u002Fgenetics physician, and intercurrent infection are exclusion criteria for this protocol, the likelihood that an acutely ill or poorly controlled patient will enroll will be minimized.\n* A subset of participants may be enrolled in the tissue collection part of the study only (i.e. if they are too sick to travel). We can may also arrange limited remote consultation with our research team and NIH consultants, the participants referring physician and the participant\u002Ftheir legal guardian through the telephone or an NIH supported telehealth platform for participants who are unable to safely travel to NIH. This would not replace a study visit but would be used when travel isn t possible due to extenuating circumstances (e.g. pandemic). Participants would be encouraged to follow-up for a more thorough in-person evaluation when they are able to travel to NIH.\n* For the healthy volunteers, they will be excluded if they have halitosis, cavities, dental or gingival problems, respiratory diseases (for example, asthma or recent history of COVID19), use tobacco products (for example, cigarette smoking or chewing tobacco), or use electronic nicotine delivery systems (for example, use of e-cigarettes or vaping devices), as this may interfere with accurate measurement of their volatile organic compounds. NIH staff and their family members will be eligible to participate in the healthy volunteer portion of the study.","1 Month","100 Years",{"count":53,"type":22},1045,"Background:\n\nPeople s bodies need to break down food into the chemicals. These chemicals are used for energy and growth. Some people cannot process all chemicals very well. Too much of some chemicals can cause diseases. One of these diseases is called propionic acidemia (PA). People with PA can have problems with growth, learning heart, abdomen, and other organs. Researchers want to better understand how these problems happen.\n\nObjective:\n\nTo learn more about propionic acidemia and the genes that might contribute to it.\n\nEligibility:\n\nPeople at least 2 years old with PA who can travel to the clinic\n\nSome unaffected family members\n\nDesign:\n\nParticipants will have a 3 to 5-day hospital visit every year or every few years. Family members may have just 1 visit.\n\nDuring the family member visit, they may have:\n\nMedical history\n\nPhysical exam\n\nSamples of blood and urine\n\nQuestions about diet and a food diary\n\nDoctors and nurses may do additional studies:\n\nSamples of saliva, skin and stool\n\nFluid from a gastronomy tube, if participants have one\n\nDental and eye evaluations\n\nA kidney test - a small amount of dye will be injected and blood will be collected.\n\nConsultations with specialists\n\nA test of calories needed at rest. A clear plastic tent is placed over the participant to measure breathing.\n\nStable isotope study. Participants will take a nonradioactive substance then blow into a bag.\n\nPhotos taken of the face and body with underwear on\n\nUltrasound of the abdomen\n\nHeart tests\n\nHand x-ray\n\nBrain scan\n\nParticipants may have other tests if study doctors recommend them. They will get the results of standard medical tests and genetic tests.",[29,56,57],"Propionic Acidemia","Organic Acidemia",[57,59,60],"Inborn Errors of Metabolism","Natural History",{"date":34,"type":35},{"date":63,"type":35},"2016-11-29",{"date":65,"type":22},"2036-08-31",{"name":67,"class":68},"National Human Genome Research Institute (NHGRI)","NIH",2,{"id":71,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":16,"sex":17,"minAge":50,"maxAge":51,"enrollmentInfo":72,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":54,"conditions":73,"keywords":74,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":79,"leadSponsor":80,"locationsCount":69},"100277362",{"count":53,"type":22},[29,56,57],[57,59,60],"2026-07-01",{"date":77,"type":35},"2026-07-02",{"date":63,"type":35},{"date":65,"type":22},{"name":67,"class":68},{"id":82,"slug":4,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":16,"sex":17,"minAge":87,"maxAge":51,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":105,"completionDateStruct":4,"leadSponsor":107,"locationsCount":109},"100143838","NCT01143454","Characterization of Patients With Uncommon Presentations and\u002For Uncommon Diseases Associated With the Cardiovascular System","Cardiovascular Disease Discovery Protocol","* INCLUSION CRITERIA:\n\nEligible subjects may include anyone over 1 year of age who is affected with diseases\u002Fdisorders (index cases), or who is a relative of a person who is affected with diseases\u002Fdisorders. Relatives may include genetic carriers and non-carriers.\n\n* Healthy adult volunteers must be 18 years of age or older, and must agree to have blood or tissue samples studied, and potentially stored for future research.\n* Index cases enrolled in this protocol will have been referred with a known or suspected pathology that may be associated with cardiovascular dysfunction or risk with a suspected atypical presentation, heritable disorder, or genetic predisposition. The investigator with expertise in the presentation of the subject, along with consulting specialists, will review the medical history and may review any medical records that are available of prospective subjects and offer admission based upon the potential to help the individual, to learn from the subject, or to initiate clinical or basic research suggested by the subject s workup.\n\nEXCLUSION CRITERIA:\n\n* Persons of less than 1 year of age or greater than 100 years of age\n* Healthy volunteers unable to give informed consent or who decline to have blood and\u002For tissue studies, or who do not consent to have samples stored for future research may be excluded from this study.\n* Pregnant women\n* Persons who are not fluent in the English language will be excluded from Patient Reported Outcome Questionnaires. Such persons would be unable to properly complete questionnaires that are only valid in the English language.","1 Year",{"count":89,"type":22},5000,"Background:\n\n\\- Researchers are interested in studying individuals who have known or suspected metabolic, inflammatory or genetic diseases that may put them at a high risk for heart diseases or diseases of their blood vessels. Depending on the condition being studied, both affected and nonaffected individuals may be asked to provide blood and other samples and may undergo tests to evaluate the heart, blood vessels and lung function. The testing is tailored to the individual and\u002For condition being studied. Nonaffected individuals may include relatives of affected individuals and healthy nonrelated volunteers.\n\nObjectives:\n\n\\- To study individuals who have or are at risk for cardiovascular diseases, and in some cases their unaffected relatives and healthy volunteers.\n\nEligibility:\n\n\\- Individuals between 1 and 100 years of age. Participants may be healthy volunteers, individuals with cardiovascular diseases, or unaffected relatives of individuals with cardiovascular diseases.\n\nDesign:\n\n* Participants will have some or all of the following tests, as directed by the study researchers:\n* Photography of the face and full body\n* Body measurements\n* Radiography, including chest or limb x-rays\n* Metabolic stress testing to study heart and muscle function\n* Echocardiography to study heart function\n* Magnetic resonance imaging (MRI) studies, including cardiovascular MRI, angiography, and contrast MRI, to study heart function and performance\n* Computed tomography (CT) angiogram to obtain images of the heart and lungs\n* Positron emission tomography (PET) imaging to study possible fat infiltration of the heart\n* Six-minute walk test to study heart, lung, and muscle function and performance\n* Vascular ultrasound to study blood vessel walls\n* Blood, tissue, and other specimens will be collected for research and testing, and will be taken either as part of the clinical study or during surgical procedures.\n* Follow-up studies may be performed under separate research protocols.",[29,28,92,93,94,95],"Li-Fraumeni Syndrome","Cardiomyopathy","Atherosclerosis","Inflammatory Disease",[97,98,99,100,60,101,102],"Cardiac Disease","iPS Cells","Cardiac Risk Factors","Cardiac Disease Discovery","Heart Disease","Heart Disease Risk","2026-06-30",{"date":75,"type":35},{"date":106,"type":35},"2010-07-21",{"name":108,"class":68},"National Heart, Lung, and Blood Institute (NHLBI)",3,{"id":111,"slug":4,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":43},"100394283","NCT04414046","TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Primary Immunodeficiency and Inherited Metabolic Disorders in Children","Study of TCR Alpha Beta T-Cell and CD19 B-Cell Depletion for Hematopoietic Cell Transplantation From Haploidentical Donors in the Treatment of Primary Immunodeficiency and Inherited Metabolic Disorders in Children","Inclusion Criteria:\n\n1. Patient with any form of primary immune deficiency\u002Fdysregulatory disorders characterized by aberrant immune function, abnormal hematopoiesis, systemic or organ specific autoimmunity and\u002For non-malignant lymphoproliferation. This includes, but not limited to:\n\n   I. Disorders of phagocytes: Chronic granulomatous disease, Leukocyte adhesion deficiency, defects of IL-10 pathway, MonoMac syndrome\n\n   II. Defects of cellular and humoral immunity: Severe Combined Immunodeficiency Disorder (infants with classic SCID up to 2 years of age will be excluded due to other open protocol), X-linked hyper-IgM syndrome, DOCK8 deficiency, ZAP70 deficiency, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, NEMO deficiency.\n\n   III. Disorder of immune dysregulation: Immunodysregulation polyendocrinopathy enteropathy X-linked (IPEX) syndrome, CTLA4 deficiency, LRBA deficiency, STAT1 GOF, STAT3 GOF, X-linked lymphoproliferative disease etc.\n\n   IV. Other PIDs and immune dysregulatory disorders who can be benefitted by HCT as deemed appropriate by the PI and the treating immunologist.\n2. Histiocytic disorders including hemophagocytic lymphohistiocytosis (familial HLH (types 1-5), secondary HLH (refractory to therapy or with recurrent episodes of hyper inflammation) and multisystem refractory Langerhans cell histiocytosis.\n3. Metabolic disorders that could improve or stabilize after stem cell transplantation such as mucopolysaccharidoses, neurodegenerative disorders, osteopetrosis, etc.\n\nInclusion Criteria:\n\n1. Patient has a suitable genotypic identical match of 5\u002F10. The donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-C, HLA-DRB1 and HLA-DQB1.\n2. Patients must have adequate organ function measured by:\n\n   1. Cardiac: asymptomatic or if symptomatic then LVEF at rest must be ≥ 40% or SF ≥ 26%\n   2. Pulmonary: asymptomatic or if symptomatic DLCO ≥ 40% of predicted (corrected for hemoglobin) or pulse oximetry ≥ 92% on room air if the patient is unable to perform pulmonary function testing.\n   3. Renal: Creatinine clearance (CrCl) or glomerular filtration rate (GFR) must be \\> 50 mL\u002Fmin\u002F1.73 m2.\n   4. Hepatic: Serum conjugated (direct) bilirubin \\\u003C 2.0 x ULN for age; AST and ALT \\\u003C 5.0 x ULN for age.\n   5. Karnofsky or Lansky (age-dependent) performance score ≥ 50\n3. Signed written informed consent\n\nExclusion Criteria:\n\n1. Participants who have an HLA-matched sibling who is able and willing to donate bone marrow. Patients with a HLA-matched unrelated donors are not excluded.\n2. Pregnant or breastfeeding females.\n3. Patient has HIV or uncontrolled fungal, bacterial or viral infections.\n4. Patient has received prior solid organ transplant.\n5. Patient has active GVHD (\\> grade II) or chronic extensive GVHD due to a previous allograft at the time of inclusion.","21 Years",{"count":118,"type":22},17,"INTERVENTIONAL",[121],"PHASE2","This research is being done to learn if a new type of haploidentical transplantation using TCR alpha beta and CD19 depleted stem cell graft from the donor is safe and effective to treat the patient's underlying condition. This study will use stem cells obtained via peripheral blood or bone marrow from parent or other half-matched family member donor. These will be processed through a special device called CliniMACS, which is considered investigational.",[124,29],"Primary Immune Deficiency Disorders","2026-06-29",{"date":75,"type":35},{"date":128,"type":35},"2020-07-22",{"date":130,"type":22},"2027-06-30",{"name":132,"class":42},"Johns Hopkins All Children's Hospital",{"id":134,"slug":4,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":138,"maxAge":51,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":141,"conditions":142,"keywords":147,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":43},"100268136","NCT02769975","Evaluation of Children With Endocrine and Metabolic-Related Conditions","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Participants with known or suspected endocrine disorder age 3 months-18 years are eligible for this protocol.\n* Relatives ages 3 months-100 years may be enrolled if clinically indicated for the diagnosis of a proband.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Lack of suspected endocrine disorders.\n* Any medical, physical, psychiatric, or social conditions, which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the patient, will exclude participation. Patients who are critically ill, unstable, or with severe organ failure that may affect\u002Flimit the endocrine evaluation and place unsustainable demands on Clinical Center or NICHD resources will be excluded.","3 Months",{"count":140,"type":22},15000,"Background:\n\nEndocrine glands give off hormones. Researchers want to learn more about the disorders that affect these glands in children. These disorders might be caused by changes in genes. Genes contain DNA, which is the blueprint of how a cell works. Researchers want to identify the genes involved in endocrine and metabolic disorders. This might help develop new ways to diagnose and treat the disorders.\n\nObjective:\n\nTo study the inheritance of endocrine or metabolism disorders.\n\nEligibility:\n\nChildren ages 3month-18 with known or suspected endocrine or metabolism disorders.\n\nFamily members ages 3months-100. They may participate in the DNA part of the study.\n\nDesign:\n\nParticipants will be screened with a review of their medical records. Their parents or guardians will allow the records to be released.\n\nParticipants will have a clinic visit. This may include a physical exam and medical history.\n\nParents or guardians will give their consent for the study. Participants may have tests, surgery, or other procedures to help diagnose or treat their condition. These could include:\n\nBlood, urine, and saliva tests\n\nGrowth hormone test\n\nPituitary and adrenal function tests\n\nPicture of chromosomes\n\nImaging tests. These may include X-ray, ultrasound, scans, or a skeletal survey.\n\nGenetic tests\n\nSleep study\n\nMedical photographs\n\nIf surgery is done, a tissue sample will be taken.\n\nParticipants may have follow-up visits for diagnosis and treatment.\n\nParticipating relatives will have one visit. This will include medical history and blood and saliva tests. The blood and saliva will be used for DNA testing.",[143,144,145,29,146],"Adrenal Insufficiency","Growth Disorder","Endocrine Diseases","Bone Diseases, Metabolic",[148,28,149,144,150],"Endocrinology","Pediatric","Pubertal Development","2026-06-24",{"date":153,"type":35},"2026-06-25",{"date":155,"type":35},"2016-07-12",{"date":157,"type":22},"2030-12-31",{"name":159,"class":68},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)",{"id":161,"slug":4,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":16,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":43},"100559153","NCT06560424","Cardiovascular and Metabolic Sciences Biorepository","Inclusion Criteria:\n\n* Willing and able to sign the informed consent document\n\nExclusion Criteria:\n\n* Chronic anemia (hemoglobin consistently \\\u003C9 g\u002FL)",{"count":166,"type":22},10000,"The purpose of the Cardiovascular and Metabolic Sciences Biorepository is to collect and store information and biospecimens (blood, urine, stool, and heart tissue) from patients with and without cardiovascular and metabolic diseases to create a readily available biorepository of samples and related medical health information to expedite future research into the causes and consequences of cardiovascular and metabolic diseases.",[169,29],"Cardiovascular Diseases",[171],"Biorepository","2026-06-23",{"date":153,"type":35},{"date":175,"type":35},"2024-09-18",{"date":177,"type":22},"2050-12-31",{"name":179,"class":42},"The Cleveland Clinic",{"id":181,"slug":4,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":119,"phases":188,"briefSummary":190,"conditions":191,"keywords":208,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":69},"100526751","NCT06138821","Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial","Effect of Endoscopic Sleeve Gastroplasty on Patients With Obesity and Concomitant Metabolic Dysfunction-Associated Steatohepatitis (MASH): A Multicenter, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 (male or female)\n2. BMI ≥30 kg\u002Fm2 or ≥27 kg\u002Fm2 with at least one obesity-related comorbidity\n3. Self-reported stable weight (no weight change \\>5%) for 6 months prior to the first study visit\n4. Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory\u002Fimaging\u002Fadditional tests, and completing diet counseling\n5. Willingness to NOT start a new anti-obesity medication for the following 12 months\n6. Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete routine follow-up visits\n7. Ability to give informed consent\n8. Women of childbearing potential (i.e., not post-menopausal, nor surgically sterilized) must agree to use adequate birth control methods\n\nExclusion Criteria:\n\n1. Known history of other chronic liver diseases (viral hepatitis, autoimmune hepatitis, drug-induced hepatitis, and genetic)\n2. Treatment with vitamin E (at doses ≥800 IU\u002Fday), pioglitazone, obeticholic acid, or resmetirom \\\u003C90 days before the first study visit\n3. History of foregut or gastrointestinal (GI) surgery (except uncomplicated fundoplication, cholecystectomy or appendectomy)\n4. Prior bariatric surgery\n5. Prior endoscopic sleeve gastroplasty\n6. Any inflammatory disease of the GI tract, including severe (LA Grade C or D) esophagitis, Barrett's esophagus with dysplasia, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease\n7. Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses\n8. Severe gastroesophageal reflux disease (GERD)\n9. A structural abnormality in the esophagus or pharynx, such as a stricture or diverticulum, that could impede passage of the endoscope.\n10. Achalasia or any other severe esophageal motility disorder\n11. Chronic abdominal pain\n12. Gastroparesis or intractable constipation\n13. Hepatic insufficiency or cirrhosis\n14. Severe coagulopathy\n15. Insulin-dependent diabetes (either type 1 or type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or HgbA1C ≥ 12%\n16. Patients on an anti-platelet agent, anticoagulant agent or chronic\u002Froutine use of NSAIDs\n17. Patients on corticosteroids, immunosuppressants, or narcotics\n18. Patients on an anti-seizure or anti-arrhythmic medication\n19. Patients who are pregnant or breastfeeding\n20. Excessive alcohol consumption (\\>20 g per day for women; \\>30 g per day for men)\n21. Active smoking\n22. History of poorly controlled hypertension, coronary artery disease, congestive heart failure, cardiac arrhythmia\n23. History of respiratory diseases such as chronic obstructive pulmonary disease (COPD) requiring steroids, pneumonia, or cancer\n24. History of autoimmune connective tissue disorder such as lupus, scleroderma or immunocompromised disease\n25. History of active malignancy\n26. History of genetic or hormonal causes for obesity, such as Prader Willi syndrome\n27. History of endocrine disorders affecting weight, such as uncontrolled hypothyroidism\n28. Eating disorders, including night eating syndrome, bulimia, binge eating disorder or compulsive overeating\n29. Active psychological issues preventing participation in a lifestyle modification program as determined by a psychologist",{"count":187,"type":22},132,[189],"NA","Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD\u002Fmetabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery.\n\nOver the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown.\n\nIn this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.",[28,192,193,194,195,196,197,198,199,27,200,201,29,202,203,204,205,206,207],"Liver Diseases","Liver Fibrosis","Liver Fat","Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis","MASLD","MASH","Weight Loss","Insulin Sensitivity","Insulin Sensitivity\u002FResistance","Diabetes","Diabetes Mellitus, Type 2","NASH With Fibrosis","Non-Alcoholic Fatty Liver Disease","Non Alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[209,210,211,212,213,214,215,216,217,218,219,220,221],"Gut Hormones","Endoscopic Bariatric and Metabolic Therapy (EBMT)","Intragastric Balloon (IGB)","Endoscopic Suturing","Endoscopic Sleeve Gastroplasty (ESG)","Weight Management","Endoscopic Gastric Remodeling (EGR)","Endoscopic Bariatric Therapy (EBT)","Fatty Liver","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Non-Alcoholic Fatty Liver Disease (NAFLD)","Non-Alcoholic Steatohepatitis (NASH)",{"date":153,"type":35},{"date":224,"type":35},"2025-06-24",{"date":226,"type":22},"2028-06",{"name":228,"class":42},"Pichamol Jirapinyo, MD, MPH",{"id":230,"slug":4,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":235,"minAge":19,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":119,"phases":238,"briefSummary":239,"conditions":240,"keywords":243,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":43},"100560671","NCT06580184","Theoretically Informed Behavioral Intervention","Theoretically Informed Behavioral Intervention to Prevent HIV-related Comorbidities","Inclusion Criteria:\n\nSelf-identify as:\n\n* living with HIV\n* English speaking\n* Access to a device compatible with LEARN 2\n\nExclusion Criteria:\n\n\\- medical history of serious complications such as heart attack, stroke, cognitive impairment, or cancer.","MALE",{"count":237,"type":22},164,[189],"The goal of this waitlist control clinical trial is to learn if the tailored LEARN 2 platform can prevent HIV-related comorbidities with shared risk factors in men ages 18 and older living with HIV. The main question\\[s\\] are:\n\n1. Can the virtual environment improve quality of life among these participants?\n2. Does the LEARN 2 platform effectively serve as prevention education for HIV comorbidity shared risk factors?\n\nResearchers will compare participants receiving the LEARN2 virtual environment intervention to those in a waitlist control group to see if the intervention leads to improvements in quality of life and reductions in risk factors.\n\nParticipants will be asked to:\n\n1. Engage with the virtual environment weekly.\n2. Participate in virtual live health educator sessions.\n3. Complete daily assessments of personal health behaviors through Ecological Momentary Assessment.",[241,242,29],"HIV","CVD",[244,241,242,245,246,247,248,249],"Syndemic","HTN","Diabetes Mellitus","Cancer","Virtual Reality","Prevention","NOT_YET_RECRUITING","2026-06-12",{"date":253,"type":35},"2026-06-16",{"date":255,"type":22},"2026-10",{"date":257,"type":22},"2029-03-31",{"name":259,"class":42},"Yale University",{"id":261,"slug":4,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":16,"sex":17,"minAge":19,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":119,"phases":269,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":278,"locationsCount":43},"100625014","NCT07417124","Assess the Safety and Tolerability of SNS851 in Healthy Participants","A First-in-Human Study to Assess the Safety and Tolerability of Single and Multiple Doses of SNS851 in Healthy Participants","Inclusion Criteria:\n\n1. Able to provide written informed consent. Willing, committed, and able to return for all clinic visits and complete all protocol specified procedures.\n2. Healthy male or female, aged between 18 and 55 years, inclusive at screening.\n3. Body mass index (BMI) of greater than or equal to 18 kg\u002Fm2 and lesser than or equal to 32 kg\u002Fm2 at Screening.\n4. Negative human immunodeficiency virus, viral hepatitis B and C serology at Screening.\n5. No major changes in diet, alcohol intake, or physical activity within 4 weeks before dosing and no intention to modify during confinement or follow-up.\n6. No acute illness in the 4 weeks prior to check-in, as established by physical examination and medical history.\n7. Participant is willing to refrain from consuming caffeine and\u002For xanthene products (e.g., coffee, tea, chocolate, and caffeine-containing sodas, colas) for 12 hours before each study visit and while being confined to the study site.\n8. All participants of reproductive potential must use a highly effective contraceptive method from consent through 90 days after last dose.\n\nExclusion Criteria:\n\n1. Weight loss of more than 10% within the last 3 months prior to screening.\n2. Has any clinical safety laboratory result considered clinically significant by the Investigator (or designee)\n3. In the opinion of the PI (or designee), has evidence of other forms of known chronic liver disease\n4. Participants with history or pre-existing renal disease\n5. Relevant history (in the opinion of the PI or designee) of cardiac arrythmias including long QT syndrome, sudden cardiac death, or Torsades de Pointes and\u002For syncope and\u002For clinically significant cardiovascular event or history of uncontrolled hypertension or orthostatic hypotension within the last 6 months prior to the Screening Visit.\n6. QTcF interval duration \\> 450 msec for male or \\> 470 msec for female at Screening or Day 0.\n7. Evidence or history of clinically significant pulmonary and respiratory diseases, including any clinically significant pulmonary disease or sequelae of COVID-19 infection that may increase risk from study participation.\n8. Use of an investigational agent or device within 30 days or 5 half-lives since last dose of prior investigational product or device of Day 1 drug administration in this trial, whichever is longer prior to dosing or current participation in an investigational study.\n9. History of having received long-duration RNA-based therapies within 12 months of Day 1.\n10. Use of any prescription medication or concomitant medications within 14 days prior to the first dose of study drug, or use of over-the-counter medication\u002Fvitamins\u002Fsupplements within 7 days prior to the first dose of study drug. Exceptions include contraception, iron supplements for participants who have ferritin between 15-30 µg\u002FL at screening, occasional paracetamol (up to a maximum of 2 grams per day).\n11. Use of any vaccinations within 14 days prior to the first study drug administration.\n12. Use of anabolic steroids and systemic treatment with glucocorticosteroids within 3 months prior to the Screening Visit.\n13. History of substance dependence (within the last 12 months) or positive urine drug screen at screening or positive alcohol breath tests at screening.\n14. Urinary cotinine levels at screening are indicative of smoking or participant has a history of regular use of tobacco- or nicotine-containing products.\n15. Any clinically significant illness, medical\u002Fsurgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n16. In the opinion of the PI (or designee), has an aversion to, or has history of site reactions to Subcutaneous administrations that would make them unsuitable for inclusion in this trial.\n17. Has donated blood or blood products within 3 months prior to first dose administration.\n18. Presence or evidence of recent sunburn, scar tissue, tattoo, open sore or branding that, in the opinion of the PI or medically qualified designee, would interfere with the interpretation of skin adverse reactions at the injection site\n19. In the opinion of the PI (or designee), has any uncontrolled or serious disease, medical or surgical condition that may interfere with participation or data interpretation.\n20. Any other condition or prior therapy that in the opinion of the PI (or designee) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.\n21. History of hypersensitivity to oligonucleotide therapeutics or injection-site reactions.","55 Years",{"count":268,"type":22},52,[270],"PHASE1","This is a Phase I, randomized, double-blind study designed to evaluate the safety, tolerability and pharmacokinetics of subcutaneous administration of SNS851 in healthy participants.",[29],"2026-06-10",{"date":251,"type":35},{"date":276,"type":35},"2026-04-01",{"date":255,"type":22},{"name":279,"class":280},"Oneness Biotech Co., Ltd.","INDUSTRY",{"id":282,"slug":4,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":235,"minAge":286,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":290,"conditions":291,"keywords":294,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":43},"100485428","NCT05600946","Characterization of Dysmorphology in Subjects With Creatine Transporter Deficiency","* INCLUSION CRITERIA:\n\n  1. Patient is male and between 2-40 years of age, inclusive.\n  2. Patient has genomic confirmation of a pathologic mutation in the SLC6A8 gene.\n  3. Patient is able to complete study-related procedures within limitations imposed by condition under study.\n  4. Patients parents\u002Fguardians\u002Fcaregivers must provide written consent (informed consent) to study-related procedures, and if appropriate, the patient will provide an assent.\n\nEXCLUSION CRITERIA:\n\n1. Patient has had status epilepticus within 3 months of screening.\n2. Patients has had a seizure that lasts 5 minutes or longer, and a second seizure without recovering consciousness from the first one, or if a person has repeated seizures for 30 minutes or longer.\n3. Patient is unable to comply with the study procedures or has a clinical disease or laboratory abnormality that in the opinion of the investigator would potentially increase the risk of participation.","2 Years","40 Years",{"count":289,"type":22},19,"Background:\n\nCreatine transporter deficiency (CTD) is a genetic disorder that mainly affects the brain in males. CTD causes intellectual disability that can be mild to severe. People with CTD may have seizures and behavioral issues. They may have slow growth and tire easily. CTD may sometimes be confused with autism or other disorders. Better diagnostics are needed. The study team in an NIH study noted that the faces of children with CTD can look similar. For this natural history study, an expert will examine photos of children with CTD. Any shared traits found might help to diagnose CTD.\n\nObjective:\n\nTo look for shared facial features of children with CTD.\n\nEligibility: Males aged 2 to 40 years old with CTD who were in study 17-CH-0020.\n\nDesign:\n\nSome participants in study 17-CH-0020 had pictures taken of their faces. The NIH study team wants to share these photos with a colleague in Canada. This person is an expert at evaluating how genetic disorders affect people s bodies.\n\nParticipant data collected during the study may also be sent to this expert. This data may include diagnostic images and results from lab tests.\n\nSome children did not have their pictures taken during study 17-CH-0020. Parents are asked to take pictures of these children and send them to the study team. These photos can be sent to a secure portal. The photos can also be taken in-person during a clinic visit.\n\nThe photos may be printed in clinical study journals. But this is not required. Parents will be asked to sign a separate consent before the photos are published....",[292,29,293],"Cognitive Disorder","Autism Spectrum Disorder",[295,293,296,60],"Developmental Delay","Children","2026-06-03",{"date":299,"type":35},"2026-06-04",{"date":301,"type":35},"2022-10-24",{"date":303,"type":22},"2026-09-01",{"name":159,"class":68},{"id":306,"slug":4,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":287,"enrollmentInfo":311,"targetDuration":4,"studyType":119,"phases":313,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":43},"100424854","NCT04812314","Exercise Effects on Adipose Tissue Structure and Function","LG","Inclusion Criteria:\n\n* Age: 18-40\n* Body Mass Index: 27-45 kg\u002Fm2\n* No regularly planned exercise\u002Fphysical activity for at least 6 months\n* Women must have regularly occurring menses and must be premenopausal\n\nExclusion Criteria:\n\n* Evidence\u002Fhistory of cardiovascular or metabolic disease\n* Medications known to affect lipid or glucose metabolism, or inflammation\n* Weight instability ≥ ± 6 pounds in the last 3 months\n* Tobacco or e-cigarette users\n* Women must not be pregnant or actively lactating",{"count":312,"type":22},46,[189],"Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.",[28,316,29,27,199,317],"Metabolic Syndrome","Weight Gain","2026-06-02",{"date":299,"type":35},{"date":321,"type":35},"2021-03-01",{"date":323,"type":22},"2030-03-01",{"name":41,"class":42},{"id":326,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":328,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":332,"leadSponsor":333,"locationsCount":43},"100516659",{"count":21,"type":22},[26,27,28,29,30],"2026-06-01",{"date":297,"type":35},{"date":37,"type":35},{"date":39,"type":22},{"name":41,"class":42},{"id":335,"slug":4,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":235,"minAge":19,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":119,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":354,"locationsCount":43},"100521693","NCT06072911","Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer","Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)","CONTROL4LIFE","Inclusion Criteria:\n\n* have a diagnosis of prostate cancer (stage I to IV);\n* be scheduled for a prostatectomy surgery (any surgical approach);\n* have no restriction to participate in at least mild levels of physical activity, as confirmed by the Physical Activity Readiness Questionnaire (PAR-Q+);\n* speak and understand English.\n* adult: 18 years of age or older\n* optional exercise component: willing and able to commit to the 12-week intervention\n\nExclusion Criteria:\n\n* have any medical conditions that may interfere with continence (i.e. neurological diseases);\n* have any contraindications to exercise testing or training;\n* have recent (\\>6 months) modifications to any medication aiming to reduce urinary incontinence (i.e. Myrbetric);\n* do not have regular access to the internet and a smart device or a computer at home\u002F at their community center;\n* are already receiving a pelvic floor exercise program through a pelvic floor physical therapist from their community.",{"count":342,"type":22},106,[189],"The Continence, Sexual and Metabolic Health (CONTROL 4 LIFE) study will evaluate the recovery of continence, sexual function, and health outcomes in individuals who have undergone surgery for prostate cancer. The purpose of this study is to better understand the timelines of recovery for these outcomes after surgery for prostate cancer. As part of this study, all participants will receive resources offered by Alberta Health Services regarding pre- and post-prostatectomy care, including information on pelvic floor exercises. Through the CONTROL 4 LIFE study, the investigators will also be evaluating outcomes related to physical activity, fitness and quality of life. These assessments will enable the investigators to better understand how well and how long it takes for individuals to recover after surgery for prostate cancer.",[346,347,29],"Prostate Cancer","Incontinence","2026-05-28",{"date":350,"type":35},"2026-05-29",{"date":352,"type":35},"2024-02-27",{"date":103,"type":22},{"name":355,"class":42},"University of Alberta",{"id":357,"slug":4,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":363,"conditions":364,"keywords":365,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":109},"100377426","NCT04194372","Signature of the Risk Profile of Mortality in a Hospital Cohort of Patients With Metabolic Diseases","INTEGRA","Inclusion Criteria:\n\n* Diabetic: antecedent - treatment - or glycemia\\> = 1.26 g \u002F dl - or HbA1C\\> = 6.5% and or\n* Obese: BMI\\> = 30 and or\n* Metabolic syndrome defined AND\n* Patient having given written consent to participate in the study or collection of the consent of the witness\n* Social insured patient (excluding AME)\n* Patient willing to comply with all procedures of the study and its duration AND\n\nPatient also presenting a pathology among:\n\n* Cardiology:\n\n  * Coronary patient(history of myocardial infarction, coronary bypass, or coronary angioplasty or stenosis greater than 50% on an epicardial vessel documented on coronary angiography)\n  * Patient with systolic or diastolic heart failure\n  * Patient with atrial fibrillation\n  * Patient with aortic stenosis (Vmax\\> 2.5 m \u002F s)\n  * Patient with high blood pressure\n* neurology:\n\n  * ischemic stroke\n  * intracerebral hemorrhage\n  * transient ischemic attack\n* diabetology:\n\n  * Obesity without diabetes\n  * Diabetes T2\n  * T1 diabetes\n  * Monogenic Diabetes \u002F MODY\n  * African Diabetes\n  * Diabetes secondary to pancreatopathy \u002F liver cirrhosis\n  * Diabetes post transplantation \u002F post immunotherapy\n  * Diabetes associated with Steinert's disease\n* hepatology: hepatological pathology\n* nephrology: nephrology\n\nExclusion Criteria:\n\n* Unscheduled hospitalization less than 3 months old\n* Ongoing treatment :\n\n  * Cytotoxic chemotherapy\n  * Radiotherapy\n* HIV and \u002F or HCV and \u002F or active HBV infection\n* OMS score\\> = 2\n* Pregnant woman",{"count":166,"type":22},"Epidemiological studies are usually conducted in the general population in adults without complications or pathology at baseline. The results obtained are therefore often better designed for primary prevention use. The prediction of mortality risk in patients with complications and requiring hospital follow-up is less well known.\n\nThe study purpose is to determine a mortality risk profile in a hospital cohort of patients with pathologies associated with metabolic diseases.\n\nToday the \"multimaker\" scores based on a panel of biomarkers - have significantly improved the discriminating power of prediction models existing in many pathologies. It is no longer a single biomarker that can improve risk prediction but a complete and cross-sectional profile that is sought after. We aim to establish a personalised mortality risk profile by combining clinical and biological parameters including metabolomics, genetics, transcriptomics and epigenomics by high throughput screening of biological samples.",[29],[366,367,368,369],"Diabetic","CardioVascular Disease","morbi-mortality","Hospital Cohort","2026-05-20",{"date":372,"type":35},"2026-05-22",{"date":374,"type":35},"2019-12-20",{"date":376,"type":22},"2030-01",{"name":378,"class":42},"University Hospital, Lille",{"id":380,"slug":4,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":385,"enrollmentInfo":386,"targetDuration":4,"studyType":119,"phases":388,"briefSummary":389,"conditions":390,"keywords":400,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":407,"locationsCount":409},"100630707","NCT07491172","A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias","A Phase 1 Open-label, Multicenter, First-in-human, Ascending Dose Trial Evaluating the Safety and Tolerability of a Lipid Nanoparticle Formulation of CRISPR-Guide RNA-Cas9 Nuclease (CTX310) for In Vivo Editing of the Angiopoietin-like 3 (ANGPTL3) Gene in Participants With Refractory Dyslipidemias","Key Inclusion Criteria:\n\n1. Age of ≥18 and ≤75 years at the time of signing the informed consent.\n2. Able to provide written informed consent.\n3. Participants diagnosed with persistent dyslipidemias defined by TG ≥150 mg\u002FdL - and LDL-C ≥70 mg\u002FdL in participants with ASCVD, or LDL-C ≥70 or 100mg\u002FdL in participants with or without ASCVD respectively, or TG ≥500 mg\u002FdL.\n4. Refractory to the maximal intensity or MTD of standard of care lines of lipid-lowering therapies available through routine clinical care, for at least 12 weeks prior to screening\n5. Female participants must be postmenopausal or surgically sterile.\n6. All male participants and their female partners must agree to the use of an acceptable method of effective contraception for the duration of the study.\n\nExclusion Criteria:\n\n1. Participants with familial chylomicronemia syndrome (FCS). Some exceptions may apply.\n2. Evidence of liver disease, defined as but not limited to:\n\n   LFTS \\>2 × upper limit of normal (ULN), or total bilirubin \\>2 × ULN, or INR \\>1.5 × ULN, or liver stiffness measured by liver elastography\n3. Abnormal or compromised function of kidney, heart, blood or liver.\n4. Acute coronary syndrome event or stroke within 24 weeks prior to Day 1. Acute pancreatitis within 12 weeks prior to Day 1.\n5. Current use or use within 365 days from Day 1 of any hepatocyte-targeted small interfering RNA (except inclisiran).\n6. Positive serology for HIV, hepatitis B or hepatitis C (antibody, surface antigen orNAT). Serology consistent with prior immunization will be eligible for the trial.\n7. Any prior malignancy within the past 5 years, or current malignancy (exceptions for resected or removed basal cell carcinoma, squamous cell carcinoma in situ and carcinoma in situ of the cervix or breast).\n8. Women of childbearing potential.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.\n\nNote: The inclusion and exclusion criteria listed represent the global protocol. Additional or modified eligibility criteria may apply in certain countries in accordance with local regulatory and ethics committee requirements and the approved country-specific protocol.","75 Years",{"count":387,"type":22},90,[270],"This is a single-arm, open-label, multicenter, ascending dose Phase 1 trial that will enroll participants 18 to 75 years of age with dyslipidemias that are refractory to available treatments.",[391,29,392,393,394,395,396,397,398,399],"Cardiovascular","Dyslipidemias","Lipid Disorder","Hypertriglyceridemia","Heterozygous Familial Hypercholesterolemia (HeFH)","Homozygous Familial Hypercholesterolemia (HoFH)","Severe Hypertriglyceridemia (sHTG)","Mixed Hyperlipemia","Hypercholesterolaemia",[401],"Refractory Dyslipidemias","2026-05-19",{"date":372,"type":35},{"date":405,"type":35},"2024-06-21",{"date":226,"type":22},{"name":408,"class":280},"CRISPR Therapeutics AG",18,{"id":411,"slug":4,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":16,"sex":17,"minAge":287,"maxAge":416,"enrollmentInfo":417,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":43},"100445218","NCT05077579","Alzheimer\"s Imaging Biomarkers in Obesity","Neuroinflammation and Alzheimer's Disease Imaging Biomarkers in Midlife Obesity","Inclusion Criteria:\n\n1. Male and female, 40-60 years of age and any race;\n2. MMSE = or greater than 25 or a Clinical Dementia Rating Scale (CDR)=0;\n3. Willing and able to undergo MRI\n4. Willing to complete PET scans, including \\[11C\\]PiB and 18F-AV-1451 (Flortaucipir) radioactive tracer injection under protocols IRB #201409014 \\& 201906028\n5. Willing to participate in the metabolic subtyping of metabolically normal or abnormal overweight or obese status for the following three groups:\n\n   a. Group 1: MAOO criteria: i. BMI ≥25 but \\\u003C45 kg\u002Fm2; ii. Maximum body circumference \\\u003C 165 cm to ensure participants fit into the PET\u002FCT and MR scanners; iii. Fasting blood glucose: ≥100 mg\u002Fdl or blood glucose 2 h after an OGTT: ≥140 or fasting insulin: \\>20 µu\u002Fml;\n\n   b. Group 2: MNOO criteria: i. BMI ≥ 25 but \\\u003C45 kg\u002Fm2; ii. Maximum body circumference \\\u003C 165 cm to ensure participants fit into the PET\u002FCT and MR scanners; iii. Blood glucose 2 h after an OGTT: iv. HbA1c \\\u003C 5.7% v. Fasting insulin: \\\u003C 20 µu\u002Fml;\n\n   c. Group 3: MNLP criteria: i. BMI ≥18.5 but \\\u003C 25.0 kg\u002Fm2; ii. Maximum body circumference \\\u003C 165 cm to ensure subjects fit into the PET\u002FCT and MR scanners; iii. Fasting blood glucose: \\\u003C 100 mg\u002Fdl; iv. Blood glucose 2 h after an OGTT: \\\u003C 140 mg\u002Fdl; v. HbA1c \\\u003C 5.7% vi. Fasting insulin: \\\u003C 20 µu\u002Fml;\n\nExclusion Criteria:\n\n1. Any condition that in the opinion of the Investigator or designee could increase the risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with the collection of the data, (e.g., currently taking a drug for treatment of obesity);\n2. Intend to have bariatric surgery;\n3. Inability to tolerate to lie still during the scanning procedures (e.g., severe, chronic back pain);\n4. Severe claustrophobia;\n5. Women who are currently pregnant or breast-feeding;\n6. Currently receiving an active obesity study drug (or placebo) or in an obesity clinical trial;\n7. Laboratory Evaluations exclusion: • Oral glucose tolerance test should not be performed in patients who already fulfill the criteria for diabetes mellitus. These include: - History of Type 1 or 2 diabetes mellitus - Prior documentation of a fasting plasma glucose \\>7.0 mmol\u002FL or two or more occasions or clinical symptoms of diabetes e.g. polydipsia, polyuria, ketonuria and rapid weight loss with a random plasma glucose of \\>11.1 mmol\u002FL • Other contraindications for venous access as part of OGTT or blood draws: - Venous fibrosis or shunt grafts in both upper extremities - Ongoing cellulitis or infection, particularly in the upper extremities. - Presence of a hematoma at the site of vascular access. - History of hypoglycemic encephalopathy that can occur with prolonged fasting\n8. MRI exclusion: • Contraindications to MRI (e.g., certain incompatible electronic medical devices that make it potentially unsafe for the individual to participate). All participants must be willing to undergo at least two MRI screenings, supervised by Level II MRI personnel as designated by the American College of Radiology (ACR).","60 Years",{"count":418,"type":22},240,"High body fat at midlife, as evidenced by overweight or obese body mass index (BMI), is increasingly understood as a risk factor for Alzheimer's disease. However, the underlying processes and mechanisms that may underlie this risk remains unknown. With this project, the Investigator proposes to create a new cohort of cognitively normal 120 midlife individuals, age 40-60 years. The investigator and research staff will characterize the participant's overweight or obese status using metabolic tests including, an oral glucose tolerance test, fasting plasma insulin, fasting plasma glucose, and hemoglobin A1c measurements. This testing will generate categories of metabolically abnormal overweight and obese (MAOO), metabolically normal overweight and obese (MNOO), and metabolically normal lean participants (MNLP). Research staff will evaluate differences between these groups on neuroimaging with the newer classification framework of Alzheimer's biomarkers with amyloid (A), tau (T), and neurodegeneration (N), or ATN. Neurodegeneration will be assessed by atrophy on brain MRI as reflected by regional volumes on Freesurfer. Staff will also evaluate MR neuroimaging markers for neuroinflammation using a newer method called diffusion basis spectrum imaging (DBSI), developed at the Mallinckrodt Institute of Radiology at Washington University in St. Louis in collaboration with The Charles F. and Joanne Knight Alzheimer's Disease Research Center (Knight ADRC).",[421,28,29],"Alzheimer Disease","2026-05-07",{"date":424,"type":35},"2026-05-11",{"date":426,"type":35},"2021-10-18",{"date":428,"type":22},"2027-12-31",{"name":430,"class":42},"Cyrus A Raji",{"id":432,"slug":4,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":16,"sex":437,"minAge":438,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":119,"phases":442,"briefSummary":443,"conditions":444,"keywords":451,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":460,"locationsCount":69},"100480983","NCT05543083","Cognitive-Behavioral Therapy and Exercise Training in Adolescents At-Risk for Type 2 Diabetes","CBTeX","Inclusion Criteria:\n\n* Female\n* Age 12-17 years\n* Body Mass Index (BMI)\\>= 85 for age and sex\n* Type 2 Diabetes (T2D) first-or second-degree relative\n* Center for Epidemiologic Studies Depression Scale (CES-D) total score \\>=21\n\nExclusion Criteria:\n\n* T2D\u002F Type 1 Diabetes (T1D) or any major medical condition (e.g. cardiovascular, renal) that would prohibit the ability to participate in exercise training\n* Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) conduct disorder, substance abuse\u002F dependence, obsessive compulsive disorder, panic attacks, post-traumatic stress disorder, anorexia\u002Fbulimia, \\& schizophrenia\n* Insulin sensitizers, weight loss medications \\& chronic steroids\n* Structured weight loss treatment or bariatric surgery\n* Pregnancy, nursing","FEMALE","12 Years","17 Years",{"count":441,"type":22},300,[189],"The investigators are doing this study to learn more about how to prevent type 2 diabetes in teenage girls. The purpose of this study is to find out if taking part in a cognitive-behavioral therapy group, exercise training group, or a combination of cognitive-behavioral therapy and exercise training groups, decreases stress, improves mood, increases physical activity and physical fitness, and decreases insulin resistance among teenagers at risk for diabetes.",[27,445,446,447,448,449,450,29],"Depression","Depressive Disorder","Mood Disorders","Mental Disorder in Adolescence","Hyperinsulinism","Glucose Metabolism Disorders",[452,453],"Adolescent Type 2 Diabetes Prevention","Exercise Training","2026-04-17",{"date":456,"type":35},"2026-04-22",{"date":458,"type":35},"2023-06-02",{"date":257,"type":22},{"name":461,"class":42},"Colorado State University",{"id":463,"slug":4,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":16,"sex":17,"minAge":19,"maxAge":468,"enrollmentInfo":469,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":471,"conditions":472,"keywords":475,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":43},"100430733","NCT04888923","Natural History of the Human Biological Response to Environmental Exposure and Injury","Natural History of The Human Biological Response to Environmental Exposure and Injury","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Ability to provide informed consent.\n3. Able to read and speak English.\n4. Male or female, aged greater than or equal to 18.\n5. Able to travel to the NIEHS CRU for study visits.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Not willing to have samples stored for future use.\n2. Current pregnancy or lactation, by participant verbal confirmation.\n3. Any condition that, in the investigator s opinion, places the participant at undue risk for complications associated with required study procedures.","90 Years",{"count":470,"type":22},2000,"Background:\n\nEnvironmental exposures like pollution, diet, and stress can help cause human diseases, or make them worse. Researchers want to better understand how injury and inflammation are caused by these exposures. They want to collect biological and environmental samples and other data. They may use the samples to measure a range of factors, like hormones, toxins, and chemicals. This will help them improve their studies.\n\nObjective:\n\nTo identify and understand how environmental exposures contribute to human disease.\n\nEligibility:\n\nHealthy adults ages 18 and older\n\nDesign:\n\nParticipants will be screened with questions about their health history, demographics, and medicines they take.\n\nParticipants may give blood, hair, stool, saliva, and\u002For urine samples. They may have a skin punch biopsy to collect skin cells. They may give fingernail or toenail clippings. They may give a sample of exhaled breath.\n\nParticipants may give a sputum sample. They will inhale a saline mist and cough mucus into a cup.\n\nParticipants may have their nasal passages brushed, scraped, or washed.\n\nParticipants may give cheek cell samples. They will swish mouthwash and spit it into a cup.\n\nParticipants who produce sperm may give samples.\n\nParticipants may have bronchoscopy to collect fluid. A saline solution will be put into their lung and then suctioned out, washing areas of the lung.\n\nParticipants may have a pelvic or transvaginal ultrasound. They may have lung function tests.\n\nParticipants may collect household dust, urine, or stool at home.\n\nParticipants will complete surveys about their health, diet, and exposures.\n\nParticipation will last for one or more study visits.\n\nParticipants may be contacted in the future to take part in other studies.",[473,474,29],"Inflammation","Normal Controls",[476,29,473,60],"Blood Collection",{"date":478,"type":35},"2026-04-20",{"date":480,"type":35},"2021-11-16",{"date":482,"type":22},"2031-12-31",{"name":484,"class":68},"National Institute of Environmental Health Sciences (NIEHS)",{"id":486,"slug":4,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":16,"sex":17,"minAge":19,"maxAge":287,"enrollmentInfo":491,"targetDuration":4,"studyType":119,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":43},"100501249","NCT05806801","Metabolic Adaptations to Weight Loss With and Without Exercise","WAX","Inclusion criteria\n\n* Age: 18-40\n* Body Mass Index: 30-40 kg\u002Fm2\n* Weight stable (±3kg for greater than or equal to about 2 months)\n* No regularly planned exercise\u002Fphysical activity\n* Women must have regularly occurring menses and must be premenopausal\n\nExclusion criteria\n\n* EKG abnormalities\n* Evidence\u002Fhistory of cardiovascular disease, diabetes or other metabolic disease\n* Medications known to affect lipid or glucose metabolism\n* Pregnant or lactating\n* Tobacco or e-cigarette use\n* Prior experience of hypersensitivity to insulin, human albumin, and potassium chloride injection.\n* Allergies\u002Fhypersensitivity to local anesthetics of the amide type (e.g., lidocaine)\n* History of hyperkalemia or potential for developing hyperkalemia (including but not limited to taking drugs that may induce hyperkalemia such as cardiac glycosides or potassium sparing diuretics)\n* Anti-coagulant medication (e.g., Coumadin, Rivaroxaban) and Lidocaine allergy\u002Fsensitivity are exclusion criteria for the biopsy procedure.",{"count":492,"type":22},68,[189],"Study Purpose:\n\nThe combination of caloric restriction and exercise is the most common first-line treatment for obesity-related disorders, yet we know very little about how these two very different treatments work together. A deeper understanding about mechanisms underlying the health benefits of adding exercise to a weight loss program will not only aid efforts to optimize more effective lifestyle interventions, but it can also uncover novel targets for the treatment\u002Fprevention of obesity-related diseases.\n\nAlthough a reduction in body fat is the fundamental adaptation to weight loss, we know almost nothing about the effects that adding exercise has on structural and functional changes within fat tissue that may further enhance metabolic health. This is very important because many obesity-related metabolic health complications are tightly linked with abnormalities in abdominal fat tissue. We argue exercise-induced modifications in abdominal fat tissue will reveal persistent health benefits even if some weight is regained\n\nStudy Summary:\n\n10% Weight Loss Phase - Subject participation in the study will involve a series of metabolic tests before, at midpoint, and after undergoing a 10% weight loss program (with or without exercise training depending on group randomization). During this, subjects will be randomized into one of two different experimental groups:\n\n1. Moderate Intensity Continuous Training (MICT) exercise group\n2. No exercise (control) group\n\nFollow-up Phase: After completing the metabolic testing post-weight loss, all study-related diet and exercise supervision will end and subjects will be free to make their own choices regarding diet and exercise\u002Fphysical activity behavior. Subjects will then be asked to complete follow-up testing at 2-, 4- and 6- months post-weight loss.\n\nTotal involvement in the study for each subject will likely be about 10-13 months (4-7 months during weight loss phase, 6 months during follow-up phase).",[28,29,316,200,27,199],"2026-04-10",{"date":498,"type":35},"2026-04-14",{"date":500,"type":35},"2023-07-19",{"date":502,"type":22},"2028-05-31",{"name":41,"class":42},{"id":505,"slug":4,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":16,"sex":17,"minAge":509,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":119,"phases":512,"briefSummary":513,"conditions":514,"keywords":517,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":43},"100478922","NCT05516277","Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder","Inclusion Criteria:\n\n* Community-dwelling Veterans aged 50 years and older\n* Received care from a Veterans Health Administration (VHA) facility in the prior year\n* Diagnosis of PTSD\n* Diagnosis of insomnia disorder\n* Lives within a 50-mile radius of the research offices at the VA Sepulveda Ambulatory Care Center\n\nExclusion Criteria:\n\n* Active substance use or in recovery with less than 90 days of sobriety\n* Too ill to engage in the study procedures (e.g., unable to attend the in-person meetings)\n* Unable to self-consent to participate\n* Unstable housing (as this will impact the research team's ability to retrieve costly and difficult to replace monitoring equipment)\n* Severe cardiovascular or respiratory disease (e.g., ventilatory failure, CHF)\n* Unstable medical or psychiatric disorders (which are a contraindication for behavioral treatment of insomnia)\n* Comorbid sleep disorders (i.e., central sleep apnea syndrome, diagnosed narcolepsy or circadian rhythm sleep-wake phase disorders) based on medical record review and baseline assessment data, or untreated, severe sleep disordered breathing (SDB) as assessed via WatchPAT or previous clinical evaluation (apnea-hypopnea index \\[AHI\\] ≥ 30; or AHI ≥ 15 plus Epworth Sleepiness Scale \\[ESS\\] score ≥ 10) that better explain sleep difficulties","50 Years",{"count":511,"type":22},167,[189],"This pilot pre-post trial will address a gap in knowledge related to addressing modifiable risk factors for cardiometabolic disease through treating residual insomnia, sleep difficulties that remain after successful treatment of another condition, in the context of PTSD in understudied older adults. This study provides a non-medication treatment for PTSD called Cognitive Processing Therapy (CPT) followed by a non-medication sleep education and treatment program (Cognitive Behavioral Therapy for Insomnia, CBT-I) for sleep problems that remain after completing PTSD treatment in older adults with PTSD. The aims of this project are to evaluate 1) the added benefits of treating residual insomnia on sleep and PTSD symptoms; 2) the added benefits of treating residual insomnia following CPT on cardiometabolic risk biomarkers and quality of life; and 3) the durability of the sleep, PTSD, cardiometabolic and quality of life benefits of treating residual insomnia following CPT at 6-month follow-up in older adults with PTSD.",[515,516,169,29],"Posttraumatic Stress Disorder","Insomnia",[518],"Quality of Life",{"date":520,"type":35},"2026-04-15",{"date":522,"type":35},"2023-04-01",{"date":524,"type":22},"2028-03-31",{"name":526,"class":42},"University of California, Los Angeles",{"id":528,"slug":4,"hasResults":11,"nctId":529,"briefTitle":530,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":533,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":535,"conditions":536,"keywords":541,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":43},"100463707","NCT05318196","Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases","NEPHROGENE2","Inclusion Criteria:\n\n* Patients (\\> 18 year of age) with kidney disease or at risk to develop a kidney disease,\n* Patients followed by a practitioner of the Department of Nephrology and Organ Transplantations of the University Hospital of Toulouse (France)\n\nExclusion Criteria:\n\n* consent deny\n* inability of the patient or its family to give consent.","99 Years",{"count":89,"type":22},"Managing patients with renal failure requires an understanding of the molecular mechanisms that lead to its occurrence (i.e. upstream of the disease), its worsening and its persistence (i.e. downstream), while also specifying the risk of worsening renal failure (risk stratification, intolerance to the treatment or complications (infectious, metabolic, cardiovascular, cancer…). Nephrogene 2.0 aims to study these different components of kidney, immune and solid organ transplantation (SOT)-related diseases.",[537,538,539,247,29,540],"Acute Kidney Injury","Chronic Kidney Diseases","Solid-organ Transplantation","Immune Diseases",[542,543,544,545,546],"risk stratification","solid-organ transplantation","cancer","Chronic kidney disease","Acute kidney injury","2026-03-16",{"date":549,"type":35},"2026-03-19",{"date":551,"type":35},"2022-09-05",{"date":553,"type":22},"2032-09-01",{"name":555,"class":42},"University Hospital, Toulouse",{"id":557,"slug":4,"hasResults":11,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":11,"sex":17,"minAge":562,"maxAge":563,"enrollmentInfo":564,"targetDuration":4,"studyType":119,"phases":566,"briefSummary":567,"conditions":568,"keywords":585,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":596,"locationsCount":43},"100560306","NCT06575426","A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus","A Phase I\u002FIIa, Single Site, Open-Label, Ascending Dose Study to Evaluate the Safety and Efficacy of OPF-310 [Encapsulated Porcine Islet Cells for Xenotransplantation] in Subjects With Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n1. Subject must be aged 35 to 65 years of age inclusive, at the time of signing the informed consent.\n2. Subject has an established diagnosis of type 1 diabetes mellitus (T1DM)(in accordance with the American Diabetes Association's criteria), with a minimum duration since diagnosis of 5 years.\n3. If one of the following criteria (either a or b) applies:\n\n   1. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G6, insulin pump: Omnipod® 5 or t:slim X2) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n   2. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G7, insulin pump: Omnipod® 5, t:slim X2, iLet Bionic Pancreas or The Tandem Mobi System) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n4. If one of the following criteria (either a, b or c) applies:\n\n   1. Subject has had a Level 3 (severe) hypoglycemic episode (defined as having cognitive impairment requiring external assistance for recovery) at least three times within the 1 year prior to enrollment recorded in the medical record or patient log.\n   2. Subject has had a Level 3 (severe) hypoglycemic episode at least once within the 1 year prior to enrollment and demonstrates a Clarke Score ≥4, assessed by trained study personnel. The SHE(s) and Clarke Score must be recorded in the medical record or patient log.\n   3. Subject has had TBR \\>1% at glucose levels below 70mg\u002FdL and demonstrates a Clarke Score≥4, assessed by trained study personnel. TBR data used for screening and Clarke score must be recorded in the medical record or patient log.\n5. Subject has C-peptide \\\u003C0.3 ng\u002FmL following a mixed meal tolerance test or undetectable fasting C-peptide.\n6. Hemoglobin A1C (HbA1c) ≤ 9.0\n7. Contraceptive use must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n8. Subject who can agree to cooperate with lifetime follow-up after transplantation.\n9. Subject is capable of providing signed informed consent\n\nExclusion Criteria:\n\n1. Previous history of insulin resistance (defined as an average insulin dose requirement ≥ 0.8 unit\u002Fkg\u002Fday for 1 week prior to enrollment).\n2. Subject has latent autoimmune diabetes in adults (LADA), ketosis-prone (Flatbush) diabetes, or maturity onset diabetes of the young (MODY).\n3. CRP ≥ 10 mg\u002FL.\n4. Clinically unstable thyroid disease (thyroid stimulating hormone (TSH)\\\u003C the lower limit of the normal range of TSH at the site.) Patients with subclinical hyperthyroidism can be rescreened once TSH levels normalize due to treatment or other factors. In addition, patients with transiently abnormal TSH levels may undergo rescreening only once during the screening period.\n5. History of malignancies within the past 5 years, excluding basal and squamous cell carcinoma\n6. Positive serologies or nucleic acid testing for human immunodeficiency virus (HIV), hepatitis C, and hepatitis B.\n7. Active or untreated proliferative diabetic retinopathy. Subjects may be rescreened once they are successfully treated.\n8. Serious comorbid conditions that are likely to affect participation in the study, including:\n\n   1. Within the last 12 months, peripheral vascular disease with previous amputation.\n   2. History of New York Heart Association (NYHA) class II, III or IV congestive heart failure (CHF) and\u002For chronic atrial fibrillation.\n   3. Chronic obstructive pulmonary disease (COPD) or asthma with previous hospitalization for decompensation; a requirement for mechanical ventilation at any stage; or long- term treatment with oral corticosteroids.\n   4. Macroalbuminuria (\\> 300 mg albumin\u002Fgm creatinine).\n   5. Estimated glomerular filtration rate (eGFR) cut-off of \\\u003C 30 ml\u002Fmin for all per Kidney Disease Improving Global Outcomes (KDOQI) and Kidney Disease Outcomes Quality Initiative (KDIGO) consensus.\n9. Use of warfarin or other anticoagulant therapy (except aspirin), or prothrombin time and international normalized ratio (PT-INR) \\> 1.5\n10. Adrenal insufficiency being treated with corticosteroids\n11. Previous pan-peritonitis\n12. Previous cardiovascular or cerebrovascular disease. NOTE: For the purposes of this exclusion criterion, \"previous cardiovascular disease\" is defined as the presence of co-existing cardiac disease, characterized by any of the following conditions:\n\n    1. Recent myocardial infarction (within past one year), or\n    2. Angiographic evidence of non-correctable coronary artery disease, or\n    3. Evidence of ischemia on functional cardiac exam (with a stress echo test recommended for subjects with a history of ischemic disease), or\n    4. Heart failure \\> NYHAII\n13. Patients with hematopoietic stem cell abnormalities (e.g., aplastic anemia, myelodysplastic syndrome)\n14. Patients who received a blood transfusion in the previous 90 days, are anticipated to undergo surgery during the 1-year study period that may require transfusion, or have donated blood within the previous 90 days.\n15. Previous receipt of an organ, skin allograft, or other tissue transplant from an allogeneic human or animal donor.\n16. Treatment with immunosuppressive medication.\n17. Previous abdominal surgery, excluding uncomplicated appendectomy, cholecystectomy, exploratory laparoscopy and hernia repair performed prior to 12 weeks prior to enrollment.\n18. Treatment with any hypoglycemic medication prescribed for glycemic control, other than insulin therapy.\n19. Treatment with acetaminophen or hydroxycarbamide.\n20. Use of any investigational products within 12 weeks of enrollment (before entering run-in) or 5 half-lives of the investigational product, whichever is greater.\n21. Subject has history of allergy to antibiotics (Amphotericin B, Cefazolin, Ciprofloxacin, Gentamicin), which are used during manufacture of OPF-310.\n22. Previous history of insulin allergy (including porcine insulin), pork product allergy or alginate\u002Fseaweed allergy.\n23. Panel reactive antibodies (PRA) \\> 80 %.\n24. Active drug, substance or alcohol addiction.\n25. Body mass index (BMI) \\>27 kg\u002Fm2.\n26. Any other condition that, in the opinion of the Investigator, may interfere with adherence to the study protocol, including dementia, psychiatric disorder, medical condition, or a history of non-adherence to appointments or treatments","35 Years","65 Years",{"count":565,"type":22},13,[270,121],"This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the recommended Phase 2 dose (RP2D) in adult subjects with unstable Type 1 Diabetes Mellitus (T1DM) and a level 3 (severe) hypoglycemic episode at least three times within the 1 year prior to enrollment despite treatment with a closed loop system (CLS) for at least 6 months.",[569,570,571,572,573,574,575,576,577,578,579,580,581,582,583,584,29],"Diabetes Mellitus, Type 1","Hypoglycemia","Islet Cell Transplantation","Type 1 Diabetes","Type 1 Diabetes Mellitus","T1D","T1DM","T1DM - Type 1 Diabetes Mellitus","Type 1 Diabetes (T1D)","Severe Hypoglycemia","Xenotransplantation","Hypoglycemic Episode","Islet Transplantation in Diabetes Mellitus Type 1","Glucose Metabolism Disorders (Including Diabetes Mellitus)","Immune System Diseases","Autoimmune Diseases",[246,586,575,570,587,588,579,589,573,572],"Diabetes Mellitus, Type1","islet cell transplantation","pig islet cell transplantation","Porcine islet cell transplantation","2026-02-26",{"date":592,"type":35},"2026-03-02",{"date":594,"type":35},"2025-06-10",{"date":130,"type":22},{"name":597,"class":280},"Otsuka Pharmaceutical Factory, Inc.",{"id":599,"slug":4,"hasResults":11,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":603,"eligibilityCriteria":604,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":605,"enrollmentInfo":606,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":608,"conditions":609,"keywords":613,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":623,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":43},"100493945","NCT05711758","Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure","Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure: A Pilot Study","PSAM","Inclusion Criteria:\n\n* subjects must be 18-70 years of age\n* eligible for endoscopic and surgical weight loss procedures\n* body mass index (BMI) greater than 35 kg\u002Fm2\n* Individuals must be in excellent mental health\n* able to understand and sign informed consent\n* available to return for all routine follow-up study visits\n\nExclusion Criteria:\n\n* untreated H. pylori infection\n* gastroparesis\n* active smoking\n* an ongoing or a history of treatment with opioids in the last 12 months prior to enrollment\n* previous pyloromyotomy or pyloroplasty\n* gastrointestinal obstruction\n* severe coagulopathy\n* esophageal or gastric varices and\u002For portal hypertensive gastropathy\n* pregnancy or puerperium\n* any inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease)\n* malignant or premalignant gastric diseases (such as high grade dysplasia, gastric cancer, or GIST)\n* severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs)\n* lactation\n* history of gastrointestinal surgery\n* any serious health condition unrelated to their weight that would increase the risk of endoscopy\n* chronic abdominal pain\n* active psychological issues preventing participation in a lifestyle modification program\n* a known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)\n* an inability to provide informed consent\n* use of any medication that may interfere with weight loss\n* use of any medication that may interfere with gastric emptying\n* any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study","70 Years",{"count":607,"type":22},30,"Gastric myotomy has been performed for several years as a means of addressing chronic stenosis after sleeve gastrectomy and treating gastroparesis. The Pylorus Sparing Antral Myotomy (PSAM) technique has the opposite effect by leaving the pylorus intact and extending the myotomy proximally to the distal gastric body. PSAM was initially combined with ESG and shown to delay gastric emptying and provide greater weight loss without impacting tolerability (GCSI score) or the safety profile of the procedure (2 DDW GEM abstracts). PSAM has not been evaluated alone, without concomitant ESG. Since delayed gastric emptying alone is known to promote weight loss, it is thought that PSAM alone (without ESG) may provide similar efficacy, while reducing procedure time and adverse events. There have been no clinical studies that investigate the efficacy of PSAM independent of ESG. This pilot study aims to address this lack of information by evaluating the safety, tolerability, and short-term efficacy of PSAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial.",[28,610,611,29,612],"Obesity, Morbid","Obesity, Primary","Delayed Gastric Emptying Following Procedure",[614,615,616,617,618,213,619,620,621,209,622],"Pylorus Sparing Antral Myotomy (PSAM)","Gastric physiology","Gastric emptying","Pylorus-sparing antral myotomy","Myotomy","TransPyloric Shuttle (TPS)","Intragastric balloon (IGB)","Endoscopic bariatric and metabolic therapies (EBMT)","Gastric Emptying Breath Test",{"date":592,"type":35},{"date":625,"type":35},"2023-09-22",{"date":627,"type":22},"2027-12",{"name":629,"class":42},"Christopher C. Thompson, MD, MSc",{"id":631,"slug":4,"hasResults":11,"nctId":632,"briefTitle":633,"officialTitle":633,"acronym":4,"eligibilityCriteria":634,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":635,"enrollmentInfo":636,"targetDuration":4,"studyType":119,"phases":638,"briefSummary":640,"conditions":641,"keywords":643,"overallStatus":250,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":651,"leadSponsor":653,"locationsCount":69},"100625702","NCT07426068","Clinical Safety Evaluation and Preliminary Efficacy Study of Subcutaneous Myografts Transplantation","Inclusion Criteria:\n\n1. History of long-term bed rest: continuous bed rest for ≥4 weeks, with causes including neurological injury (such as brain death, stroke, or spinal cord injury), recovery after major orthopedic surgery, intensive care unit stay, or activity limitation due to chronic diseases.\n2. Evidence of muscle atrophy: a significant reduction in muscle mass or muscle strength confirmed by clinical assessment and imaging. According to dual-energy X-ray absorptiometry (DXA), appendicular skeletal muscle mass index (ASM\u002Fheight²) \\\u003C 7.0 kg\u002Fm² in men and \\\u003C 5.4 kg\u002Fm² in women, in accordance with EWGSOP2 criteria.\n3. Stable underlying medical conditions, with no acute exacerbation, and an APACHE II score of 0-20.\n4. Absence of severe comorbidities that would contraindicate surgical or transplantation interventions.\n5. Written informed consent obtained from the patient, an immediate family member, or a legal guardian, agreeing to muscle biopsy, with general health status adequate to permit subcutaneous transplantation.\n\nExclusion Criteria:\n\n1. History of malignant tumors.\n2. Coagulation disorders or current use of anticoagulant therapy.\n3. Active infection or immunodeficiency.\n4. Severe cardiac or renal insufficiency (estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m²; New York Heart Association \\[NYHA\\] class III-IV heart failure).\n5. Muscle-related diseases, including hereditary myopathies (such as muscular dystrophy) or acquired myositis (creatine kinase \\> 3 times the upper limit of normal).\n6. Severe local skin lesions or a history of allergic reactions at the injection site.\n7. Use of muscle growth-modulating medications (such as testosterone or growth hormone) within the past 6 months.\n8. Long-term use of corticosteroids or immunosuppressive therapy, including anti-rejection medications following organ transplantation.\n9. Other exclusion criteria: participation in other interventional clinical trials (excluding observational studies).\n10. Any other medical or ethical conditions deemed by the investigator to make the participant unsuitable for enrollment.","80 Years",{"count":637,"type":22},6,[639],"EARLY_PHASE1","This study aims to apply autologous differentiated myocyte subcutaneous transplantation in patients with muscle atrophy to explore its safety, feasibility, and efficacy.",[29,642],"Amyotrophy",[644,645,646],"Autologous myocyte transplantation","muscle atrophy","Muscle endocrine function","2026-02-15",{"date":649,"type":35},"2026-02-23",{"date":75,"type":22},{"date":652,"type":22},"2028-02-01",{"name":654,"class":655},"National Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, China","NETWORK",""]