[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"insulin-resistance\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:insulin-resistance":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,102,0,25,[9,50,78,109,138,169,192,235,262,298,322,348,375,403,431,450,478,504,539,563,585,614,636,663,684],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100610326","the-effects-of-cognitive-behavioral-therapy-on-insulin-resistance-in-people-with-hiv-100610326",false,"NCT07226128","The Effects of Cognitive Behavioral Therapy on Insulin Resistance in People With HIV","A Randomized, Controlled Trial Assessing the Effects of Cognitive Behavioral Therapy to Prevent Worsening Insulin Resistance in Depressed, Virologically-Suppressed, Antiretroviral-Treated Adults With HIV","Inclusion Criteria:\n\n* HIV-1 infection, documented as listed clinically in the participant's electronic medical record by any of the following tests: (1) any licensed rapid HIV test, (2) HIV enzyme test kit at any time prior to study entry, (3) at least one detectable HIV-1 antigen, or (4) at least one detectable plasma HIV-1 RNA viral load.\n* Age ≥ 18 years.\n* Ongoing receipt of stable antiretroviral therapy of any kind for at least 180 days prior to Screening\n* Meets the depression definition for this trial:\n\n  * (1) repeat PHQ-9 ≥10100 result at the Screening Visit (suggesting moderate to severe depressive symptoms), AND\n  * (2) PHQ-9 depressive disorder diagnosis (2 or more of the 9 depressive symptoms, including depressed mood or anhedonia, present in the past 2 weeks), AND\n  * (3) functional impairment (using the tenth PHQ-9 item assessing social\u002Foccupational impairment), AND\n  * (4) no evidence that the direct physiological effects of a substance, medication, or medical condition clearly account for the depressive symptoms, AND\n  * (5) no bipolar or psychotic disorders\n\nNOTE: The use of antidepressant medications is not exclusionary.\n\n* HbA1c \\\u003C 6.5% at Screening\n* HIV-1 RNA level \\\u003C 75 copies\u002FmL at Screening\n\nNOTE: There are no CD4 cell count eligibility criteria for this trial.\n\nExclusion Criteria:\n\n* Inability to complete written, informed consent\n* Inability to read and understand English as seen on a computer screen\n* Diagnosed diabetes mellitus or any previously recorded HbA1c ≥6.5%\n* History of bipolar disorder or a psychotic disorder, including schizophrenia\n\nNOTE: Depressive disorders are not exclusionary.\n\n* Incarceration at the time of any study visit\n* Active suicidality at Entry, as determined by the patient's HIV provider or social worker following a positive response (1, 2, or 3) to PHQ-9 Item #9 and a positive response (yes) to one or more of the three questions (for Question #3, the previous attempt must be within the past 10 years) on the Patient Suicidality Form (see Appendix).\n* Diagnosed disease or process, besides HIV infection, associated with increased systemic inflammation (including, but not limited to, systemic lupus erythematosus, inflammatory bowel diseases, or other collagen vascular diseases).\n\nNOTE: Hepatitis B or C co-infections are NOT exclusionary, but treatment for hepatitis C cannot be provided during study participation\n\n* End stage renal disease requiring renal replacement therapy (dialysis, transplantation).\n* Known or suspected malignancy requiring systemic treatment within 180 days of the Entry Visit.\n\nNOTE: Localized treatment for skin cancers is not exclusionary.\n\n• Therapy for serious medical illnesses within 14 days prior to the Entry Visit\n\nNOTE: Therapy for serious medical illnesses that overlaps with a study visit will result in postponement of that study visit until the course of therapy is completed; postponement outside of the allowed study visit timeframe will result in study discontinuation.\n\n* Pregnancy or breastfeeding during the study.\n* Receipt of investigational agents, cytotoxic chemotherapy, systemic immunosuppressive therapies, systemic glucocorticoids (of any dose), or anabolic steroids at the Entry Visit\n\nNOTE: Physiologic testosterone replacement therapy or topical steroids is not exclusionary. Inhaled\u002Fnasal steroids are not exclusionary as long as the participant is not also receiving HIV protease inhibitors\n\nNOTE: Use of NSAIDS and aspirin are allowed\n\n• Active drug use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if depression treatment improves insulin resistance, or how the body uses insulin to lower blood sugar, in people with HIV on HIV treatment. Researchers will compare an internet-based (online) depression treatment program called cognitive behavioral therapy with depression education. In the online group, participants will undergo 9 weekly treatment sessions. The education group will receive learning materials about depression and will be monitored every month. All participants will have 4 study visits over 12 months.",[27,28,29,30],"HIV","Depression in Adults","Insulin Resistance","Cognitive Behavior Therapy",[32,33,34,35,36],"hiv","depression","insulin resistance","diabetes","cognitive behavioral therapy","RECRUITING","2026-08-20",{"date":40,"type":41},"2026-08-21","ACTUAL",{"date":43,"type":41},"2026-04-10",{"date":45,"type":21},"2029-08-31",{"name":47,"class":48},"Indiana University","OTHER",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":49},"100494101","trial-of-the-combination-of-alpha-lipoic-acid-and-mirabegron-in-women-and-in-men-with-obesity-100494101","NCT05713799","Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity","Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity","* INCLUSION CRITERIA\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Adults 18 to 65 years of age\n2. BMI greater than or equal to 30 kg\u002Fm\\^2 and less than or equal to 45 kg\u002Fm\\^2\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Hypersensitivity and associated allergic reactions to mirabegron or alpha-lipoic acid (or similar drug substances or components).\n2. Abnormal bladder function, diagnosis of bladder outlet obstruction, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB).\n3. Type 1 diabetes mellitus; type 2 diabetes mellitus; or any person taking exogenous insulin therapy or any medication that is a hypoglycemic agent. (type 1 or Type 2 Diabetes mellitus, fasting serum glucose \\>125 mg\u002FdL, and\u002For an HbA1c test \\>6.5%).\n4. Elevated resting blood pressure \\>140\u002F90 mmHg.\n5. Individuals with eGFR \\\u003C60 ml\u002Fmin\u002F1.72 m\\^2 and a urinary albumin\u002Fcreatinine ratio UACR\\>300 mg\u002Fg.\n6. Hypo- or hyper-thyroid disease (TSH \\>5.0, or \\\u003C0.4 MIU\u002FL) that is controlled for less than one year or someone currently taking thyroid hormone replacement.\n7. Anemia, defined by hemoglobin \\\u003C11.5 g\u002FdL (females) or \\\u003C13.5 g\u002FdL (males); sickle cell anemia or other blood disorders; and\u002For wound healing problems.\n8. Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment.\n9. A clinically significant abnormal ECG and\u002For QTc interval above normal\n10. Moderate hepatic impairment (Child-Pugh Class B) or above\n11. Elevated liver enzymes \\>75 U\u002FL (ALT or AST)\n12. Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics\n13. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months.\n14. Individuals that have been on a very low-calorie diet (\\\u003C800 kcal\u002Fd), self-reported weight loss \\>5% in the preceding six months, or those taking weight loss medications.\n15. History of seizure disorder.\n16. Addiction to alcohol or substances of abuse within the last 5 years.\n17. Self-reported current alcohol consumption of more than 2 servings of alcohol per day.\n18. Self-reported current use of nicotine and\u002For tobacco products.\n19. Current use of any drugs known to:\n\n    1. Have major drug-drug interactions with mirabegron or alpha-lipoic acid\n    2. Be CYP2D6 substrates\n    3. Prolong QT interval\n    4. Alter glucose metabolism or cause insulin resistance (in last six months)\n    5. Treat diabetes mellitus\n    6. Treat hypertension\n    7. Be drugs of abuse\n20. Inability to provide informed consent.\n21. Unwilling or unable to eat metabolic meals, as determined by dietitian consult.\n22. Individuals with significant medical comorbidities or other factors that would render the individual s participation unsafe or affect the outcome of the study as assessed by the investigator.",true,"65 Years",{"count":60,"type":21},60,[62],"PHASE2","Background:\n\nObesity and related illnesses cause at least 2.8 million deaths each year worldwide. Few treatments exist for obesity that are safe and widely available. A study drug (mirabegron \\[MG\\]) combined with a supplement (alpha-lipoic acid \\[ALA\\]) may help.\n\nObjective:\n\nTo learn how MG and ALA can help the body process food.\n\nEligibility:\n\nPeople aged 18 to 65 years with a body mass index between 30 and 45 kg\u002Fm2.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam. They will have blood and urine tests and a test of their heart function. They will speak with a dietician.\n\nThe study has two phases. Each phase begins with a 2-day stay in the clinic; then the participant will take the study drugs at home for about 4 weeks, followed by another 2-day stay in the clinic. They will also have outpatient visits about 2 weeks after each clinic stay.\n\nDuring the clinic stays, participants will undergo many tests:\n\nThey will have a plastic tube (catheter) inserted into a vein in each arm. These will be used to draw blood and to infuse glucose (sugar) and insulin.\n\nThey will have imaging scans.\n\nThey will have a clear hard plastic shield placed over their head to measure oxygen and carbon dioxide as they breathe.\n\nParticipants will take the study drugs at home. Both MG and ALA are taken by mouth with water. During one phase, participants will take MG plus a placebo. A placebo looks like the study drug but doesn t contain medicine....",[29,65],"Obesity",[65,67,29,68],"Insulin Sensitivity","Placebo","NOT_YET_RECRUITING",{"date":40,"type":41},{"date":72,"type":21},"2026-08-26",{"date":74,"type":21},"2030-03-01",{"name":76,"class":77},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":49},"100652893","phase-1-alpelisib-challenge-test-act-100652893","NCT07778524","Alpelisib Challenge Test (ACT)","Alpelisib Challenge Test (ACT) for Assessment of Pancreatic β-Cell Reserve, Pilot & Feasibility Study","Inclusion Criteria:\n\n* Adults aged 18-70 years\n* Able to understand wrifen and spoken English and\u002For Spanish\n* Body mass index of 18-45 kg\u002Fm2 (or 18-42 kg\u002Fm2 for those of Asian ancestry)\n\n  * For Lean group: BMI 18.0-24.9 kg\u002Fm2 (or 18.0-22.9 kg\u002Fm2 for those of Asian ancestry)\n  * For Overweight group: BMI 25.0-29.9 kg\u002Fm2 (or 23.0-27.4 kg\u002Fm2 for those of Asian ancestry)\n  * For Obesity group: BMI 30.0-45.0 kg\u002Fm2 (or 27.5-42 kg\u002Fm2 for those of Asian ancestry)\n\nExclusion Criteria:\n\n* Inability to provide informed consent in English or Spanish\n* Unwillingness to fast (except water) for up to 18 hours\n* Unwillingness not to get out of bed and to use bedpan\u002Furinal to void for up to 15 hours\n* Documented weight change of ≥ 5.0% of baseline within the previous 3 months\n* Abnormal blood pressure\n\n  * Systolic blood pressure \\\u003C 90 mm Hg or \\> 160 mm Hg, and\u002For\n  * Diastolic blood pressure \\\u003C 55 mm Hg or \\> 100 mm Hg\n* Abnormal resting heart rate \\\u003C 55 bpm or ≥ 110 bpm\n\n  * Sinus tachycardia that has been extensively worked up and considered benign by the recruit's personal physician may be permitted at the PI's discretion\n  * Sinus bradycardia between heart rates of 45 and 54 bpm may be permitted at the PI's discretion if in a clinically appropriate setting (e.g., toned athlete, taking beta blockers)\n* Abnormal (i.e., non-regular) heart rhythm detected on physical exam\n* Abnormal screening serum electrolytes judged by the PI to be potentially clinically significant\n* Liver function abnormalities (either of the following)\n\n  * Transaminases (AST or ALT) \\> 3.0 x the upper limit of normal\n  * Total bilirubin \\> 1.25 x the upper limit of normal\n* Laboratory evidence of diabetes mellitus:\n\n  * Hemoglobin A1c ≥ 6.5%, and\u002For\n  * Fasting plasma glucose ≥ 126 mg dL-1\n* Positive qualitative β-hCG (i.e., pregnancy test) in women of childbearing potential\n* Women currently pregnant\n* Women currently breastfeeding\n* History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes):\n\n  * Hemoglobin A1c ≥ 6.5%, or rapid rise in documented HbA1c values causing clinical concern for evolving insulin deficiency\n  * Plasma glucose ≥ 126 mg\u002FdL after 8-h fast\n  * Plasma glucose of ≥ 200 mg\u002FdL at 2 h after ingestion of a 75-g glucose load\n  * Random plasma glucose ≥ 200 mg\u002FdL associated with typical hyperglycemic symptoms, diabetic ketoacidosis, or hyperglycemic-hyperosmolar state\n* History of gestational diabetes mellitus within the previous 5 years\n* Use of most antidiabetic medications within the 90 days prior to screening\n\n  * Exceptions: thiazolidinediones, sulfonylureas, meglitinides, DPP4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, amylin mimetics, acarbose, insulin\n  * Metformin is acceptable provided that recruits meet all of the inclusion criteria at screening\n* Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)\n* Cardiovascular diseases (N.B. uncomplicated hypertension is not exclusionary)\n\n  * Atherosclerotic cardiovascular disease\n  * Stable or unstable angina\n  * Myocardial infarction\n  * Ischaemic or hemorrhagic stroke\n  * Peripheral arterial disease (claudication)\n  * Use of dual antiplatelet therapy (aspirin + P2Y12 inhibitor)\n  * History of percutaneous coronary intervention\n  * Congestive heart failure (NYHA Class ≥ 2)\n  * Severe valvular heart disease (e.g., aortic stenosis)\n  * Pulmonary hypertension\n* Advanced or severe liver disease, including but not limited to:\n\n  * Advanced liver fibrosis, as determined by non-invasive testing\n  * Cirrhosis of any etiology\n  * Autoimmune hepatitis or other rheumatologic disorder affecting the liver\n  * Biliopathy (e.g., progressive sclerosing cholangitis, primary biliary cholangitis)\n  * Chronic liver infection (e.g., viral hepatitis, parasitic infestation)\n  * Hepatocellular carcinoma\n  * Infiltrative disorders (e.g., sarcoidosis, hemochromatosis, Wilson disease)\n* Psychiatric diseases causing functional impairment that:\n\n  * Are or have been decompensated within 1 year of screening, and\u002For\n  * Require use of anti-dopaminergic antipsychotic drugs associated with significant weight gain\u002Fmetabolic dysfunction (e.g., clozapine, olanzapine)\n* Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation\n* Bleeding disorders, including due to anticoagulation, or significant anemia (see above)\n* Active malignancy, or hormonally active benign neoplasm, except allowances for:\n\n  * Non-melanoma skin cancer\n  * Differentiated thyroid cancer (AJCC Stage I only)\n* Clinical concern for increased risk of volume overload, including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n* Use of certain medications currently or within 30 days prior to screening:\n\n  * Prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 30 d prior to screening, except allowances for:\n\n    * Use of drugs prescribed for indications other than the exclusionary diagnoses\u002Fpurposes listed above (e.g., ACEi\u002FARB used for uncomplicated hypertension rather than for congestive heart failure, etc.)\n    * Note, as above, that antidiabetic drugs except metformin within 30 d of screening are excluded\n  * Oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 30 days; topical and inhaled formulations are permitted\n* History of certain weight-loss (bariatric) surgery, including:\n\n  * Roux-en-Y gastric bypass\n  * Biliopancreatic diversion\n  * Restrictive procedures (lap band, sleeve gastrectomy) performed within the past 6 months\n* Clinical concern for alcohol overuse based on chart review and\u002For by recruit's report of more than 14 standard drinks per week for males or more than 7 standard drinks per week for females\n* Regular tobacco use (smoking more than 1 cigarette per week) or regular nicotine vaping (daily)\n* Clinical concern for use of illicit drugs other than marijuana or lawfully prescribed medications based on recruit's report, chart review, and point-of-care urine drug test at screening\n* History of or ongoing febrile illness within 14 days of screening\n* Any other disease or condition or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and\u002For interfere with the analysis of study data.\n* Known allergy\u002Fhypersensitivity to any component of the medicinal product formulations (including soy, cow dairy, or gluten), other biologics, venipuncture materials, plastics, adhesive or silicone, or ongoing clinically important allergy\u002Fhypersensitivity as judged by the investigator.\n* Concurrent enrollment in another clinical study of any investigational drug\u002Fbiologic therapy within 5 half-lives of an investigational agent or biologic.","70 Years",{"count":87,"type":21},15,[89],"PHASE1","The goal of this study is to test a potentially easier method for measuring how much insulin a person is capable of producing than the current gold-standard method, the \"hyperglycemic clamp.\" Participants will come in for a two-day (overnight) visit in which they will first undergo a \"hyperglycemic clamp,\" in which they receive an intravenous (into the vein) infusion of glucose (sugar) in order to measure the maximum amount of insulin their body produces in response. They will then consume a series of three standardized meals throughout the rest of the day. At 23:00, they will take a single dose of alpelisib, a drug that interferes within insulin's actions in the body. Then, the following morning, they will undergo a \"Mixed Meal Tolerance Test\" in which they consume a standardized liquid nutritional beverage and have blood drawn periodically before and during the test.",[29,92,93,94],"Type 2 Diabetes","Obesity & Overweight","Healthy Adult Participants",[96,97,98,65,99,100],"Insulin resistance","Type 2 diabetes","Hyperinsulinemia","Overweight","Healthy volunteers","2026-08-18",{"date":40,"type":41},{"date":104,"type":21},"2026-09-01",{"date":106,"type":21},"2028-08-31",{"name":108,"class":48},"Columbia University",{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":134,"leadSponsor":136,"locationsCount":49},"100652281","inositol-and-metformin-administration-in-mediterranean-diet-and-low-carbohydrate-diets-in-women-with-pcos-100652281","NCT07770711","Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS","Comparison of Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With Polycystic Ovary Syndrome","Inclusion Criteria:\n\n* Women aged 20-40\n* Diagnosed with PCOS (Rotterdam, 2004)\n* Insulin resistant (newly diagnosed or diagnosed within the last 3 months)\n* Obese according to the World Health Organization (2006) in grades 1 and 2 (BMI: 30-40 kg\u002Fm²)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Those undergoing\u002Fcontemplating IVF treatment\n* Early menopause diagnosis\n* Diabetes diagnosis, use of oral antidiabetic agents\n* Chronic diseases (liver, kidney diseases, cancer)\n* Psychiatric illnesses\n* Those taking routine medication for any reason\n* Use of hormonal contraceptive methods within the last 3 months\n* Active smokers and alcohol users or social drinkers\n* Change in body weight of more than 10% in the last 6 months for any reason","FEMALE","20 Years","40 Years",{"count":120,"type":21},90,[24],"Polycystic ovary syndrome (PCOS) is a common endocrine disorder frequently associated with obesity, insulin resistance (IR), and metabolic dysfunction. Although lifestyle modification is recommended as first-line therapy, the optimal dietary approach for women with PCOS remains uncertain. This randomized, controlled, open-label, parallel-group trial aims to compare the effects of a Mediterranean diet (MD) and a low-carbohydrate diet (LCD), each combined with metformin, inositol, or folic acid (active control), in obese women with PCOS and IR. A total of 102 participants will be randomly assigned to one of six intervention groups and followed for two months. Anthropometric measurements, body composition, biochemical parameters, and hedonic hunger will be assessed at baseline and after the intervention. The primary outcome is the change in insulin resistance, assessed by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), from baseline to 2 months. Secondary outcomes include changes in body composition, metabolic and biochemical parameters, and hedonic hunger.",[124,29,125],"PCOS (Polycystic Ovary Syndrome)","Obesity (BMI>30)",[127,128,34,129,130],"Mediterranean diet","low-carbohydrate diet","inositol","pcos","2026-08-13",{"date":101,"type":41},{"date":38,"type":21},{"date":135,"type":21},"2027-06",{"name":137,"class":48},"Dicle University",{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":150,"conditions":151,"keywords":156,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":4},"100652253","phase-3-efficacy-and-safety-of-semaglutide-versus-placebo-on-cardiometabolic-profile-in-patients-with-schizophrenia-with-metabolic-syndrome-100652253","NCT07770282","Efficacy and Safety of Semaglutide Versus Placebo on Cardiometabolic Profile in Patients With Schizophrenia With Metabolic Syndrome","Efficacy and Safety of Semaglutide Versus Placebo on Cardiometabolic Profile in Patients With Schizophrenia With Metabolic Syndrome: A Multicentre, Double-Blind, Randomised Controlled Trial (ESCaMS Trial)","Inclusion Criteria:\n\n* Clinically diagnosed schizophrenia (ICD-11) on a second-generation antipsychotic (SGA) for more than 6 months.\n\n  * Metabolic syndrome per NCEP ATP III definition.\n  * Aged above 25 years, any gender.\n  * Patient \u002F Legally Authorised Representative (LAR) provides voluntary written informed consent.\n\nExclusion Criteria:\n\n* ● On clozapine, aripiprazole, or a combination of SGAs.\n\n  * Any contraindication to semaglutide.\n  * Comorbid severe psychiatric, medical or neurological disorder.\n  * History of organicity or significant head injury.\n  * Pregnant or breastfeeding.","60 Years",{"count":147,"type":21},600,[149],"PHASE3","Patients with schizophrenia on second-generation antipsychotics have a high burden of metabolic syndrome and elevated cardiovascular risk, with few effective treatment options. This multicentre, double-blind, placebo-controlled randomised trial evaluates whether adjunctive oral semaglutide 3 mg once daily, added to treatment as usual, reduces 10-year cardiovascular risk (QRISK3) and improves insulin resistance, lipids, weight and metabolic biomarkers over 24 weeks compared with placebo, while confirming psychiatric safety and tolerability.",[152,153,154,155,29],"Schizophrenia Disorder","Metabolic Syndrome","Antipsychotic-induced Weight Gain","Cardiovascular Risk",[157,158,159,160,161],"Semaglutide","Metabolic syndrome","QRISK3","Cardiometabolic risk","Schizophrenia",{"date":101,"type":41},{"date":164,"type":21},"2026-12-01",{"date":166,"type":21},"2030-12-30",{"name":168,"class":48},"All India Institute of Medical Sciences, Bhubaneswar",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":57,"sex":17,"minAge":177,"maxAge":58,"enrollmentInfo":178,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":49},"100632655","determining-cell--and-spatially-distinct-skeletal-muscle-transcriptional-aberrations-in-insulin-resistance-100632655","NCT07516509","Determining Cell- and Spatially-distinct Skeletal Muscle Transcriptional Aberrations in Insulin Resistance","Determining Cell- and Spatially-distinct Skeletal Muscle Transcriptional Aberrations With Insulin Resistance","POINTS 2","Inclusion Criteria:\n\n* All Groups\n\n  1. 30 to 65 years of age\n  2. Stable weight (No Gain\u002FLoss of \\>10 lbs in 6 months)\n  3. Sedentary (≤ 1 continuous exercise\u002Fweek)\n  4. Non-smoker\n  5. Resting Blood Pressure ≤ 150mmHg systolic and ≤ 95 mmHg diastolic\n\nGroup A - Lean individuals with insulin sensitivity (IS-Lean)\n\n1. BMI 18-25 kg\u002Fm2\n2. Hemoglobin A1c ≤ 5.6% at screening\n3. Blood glucose level ≤ 140 mg\u002FdL 2hr after a 75g oral glucose tolerance test\n\nGroup B - Individuals with obesity and insulin sensitivity (IS-Obesity)\n\n1. BMI 30-40 kg\u002Fm2\n2. Hemoglobin A1c ≤ 5.6% at screening\n3. Blood glucose level ≤ 140 mg\u002FdL 2hr after a 75g oral glucose tolerance test\n\nGroup C - Individuals with obesity and insulin resistance (IR-Obesity)\n\n1. BMI 30-40 kg\u002Fm2\n2. Hemoglobin A1c ≤ 6.4 % at screening\n3. Blood glucose level 140-199 mg\u002FdL 2hr after a 75g oral glucose tolerance test\n\nExclusion Criteria:\n\n1. Clinically significant CVD including h\u002Fo MI, within the past year\n2. Peripheral Vascular Disease\n3. Diagnosed with Type I or Type II diabetes\n4. Hepatic, renal, muscular\u002Fneuromuscular, or active hematologic\u002Foncologic disease\n5. Previous history of pulmonary emboli\n6. Peripheral Neuropathy\n7. Anemia (Hematocrit \\\u003C34%, Hemoglobin \\\u003C 14 gm\u002FdL for men and \\\u003C12.3 gm\u002FdL for women) at screening\n8. Currently pregnant (pregnancy test performed on day of DEXA scan in women of child-bearing potential); post-partum during the last 12 months; lactating during the last 12 months; planning to become pregnant during the participation period\n9. Polycystic Ovarian Syndrome (PCOS) (self-report)\n10. Hospitalization for COVID-19 infection in the past 12 months; individuals who tested positive for COVID-19 but were not hospitalized must be symptom-free at least 14 days\n11. Partial and\u002For full hysterectomy (self-report)\n12. Not willing to archive biospecimens for future use\n13. Any contraindications to exercise testing according to ACSM guidelines\n14. Inability and\u002F or unwillingness to comply with the protocol as written\n15. Active alcohol or substance abuse (Past 5 Years)\n16. Positive toxicology result from screening visit or chronic use of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Methadone, Opiate, THC, Cannabis, Tricyclics, or Oxycodone.\n17. Dyslipidemia (fasting triglycerides \\>500 mg\u002FdL; low-density lipoprotein cholesterol (LDL-C) \\>190 mg\u002FdL; total cholesterol \\>300 mg\u002FdL);\n18. ALT \\>80, AST\\>80, Alk Phos \\>240 if a participant presents with liver functions out of these ranges at screening the MI or PI can give discretion to participate\n19. Proteinuria (defined as \\> 1+) at screening\n20. Kidney disease (creatinine \\>1.6 mg\u002Fdl or estimated glomerular filtration rate \\\u003C60 mL\u002Fmin\u002F1.73m2);\n21. Self-reported chronic, active, or latent infection requiring chronic antibiotic or anti-viral treatment; Human Immunodeficiency Virus (HIV); active hepatitis B or C undergoing antiviral therapy.\n22. Receiving active treatment (including monoclonal antibodies) for autoimmune disorders within the last 6 months;\n23. Hypothyroidism (sTSH\\>8) at screening or on thyroid replacement therapy\n24. Abnormal bleeding or coagulopathy (self-report) or history of a bleeding disorder or clotting abnormality\n25. History of cancer (other than non-melanoma skin cancer) within the last 5 years (not in remission); anti-hormonal therapy (e.g., for breast or prostate cancer) within the last 6 months;\n26. Previous bariatric or other surgery for obesity\n27. Females currently on hormone replacement therapy (HRT) less than 6 months\n28. Females with an irregular menstrual cycle\n29. Previous difficulty with lidocaine or other local anesthetic\n30. ACS symptoms:\n\n    * Positive ECG (\\> 2mm ST segment depression) without PCP cardiologist permission to participate\n    * Signs or symptoms of cardiovascular decomposition (eg. hypotensive response to exercise)\n    * Onset of angina or angina like symptoms, shortness of breath, change in heart rhythm, signs of poor perfusion (light-headedness), tightness.\n31. The following medication use is exclusionary;\n\n    * Dose change for any chronic-use drug in the last 3 months;\n    * Any medications that can alter glucose homeostasis (eg. steroids, glucocorticoids, nicotinic acid). Acute therapy (5-7 days) is not exclusionary however; participant must be agreeable to a washout period of 5-7 days prior to day of biopsy.\n    * Blood thinners such as Coumadin, Lovenox etc. Aspirin is not exclusionary however; participant must be agreeable to a washout period of \\> 10 days prior to day of biopsy\n    * All Weight loss medications including but not limited toGLP-1 agonists- Wegovy, liraglutide, semaglutide, Trulicity (dulaglutide), Phentermine and Contrave\n    * Cardiovascular: beta blockers and centrally acting anti-hypertensive drugs, anticoagulants, antiarrhythmics, and antiplatelet drugs (other than aspirin ≤100 mg\u002Fday);\n    * Psychiatric: chronic use of medium- or long-acting sedatives and hypnotics, including all benzodiazepines (short-acting non-benzodiazepine sedative-hypnotics are allowed), mood stabilizers, antiepileptic drugs, stimulants, Attention-Deficit\u002FHyperactivity Disorder (ADHD) drugs, anti-psychotic drugs, anti-depressant medication (e.g. Bupropion, selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine re-uptake inhibitors (SNRIs)).\n    * Pulmonary\u002FInflammation: chronic oral steroids (occasional use of inhaled steroids are allowed), burst\u002Ftaper oral steroids more than once in the last 12 months, B2-agonists (allowed if on stable dose at least 3 months).\n    * Genitourinary: 5-alpha reductase inhibitors, daily use of phosphodiesterase type 5 inhibitor.\n    * Hormonal: androgenic anabolic steroids, anti-estrogens, anti-androgens, estrogens and\u002For progestins used for reasons other than birth control, growth hormone, insulin like growth factor-I, growth hormone releasing hormone,\n    * any drugs used to treat diabetes mellitus or lower blood glucose including metformin, thiazolidinediones, SGLT-2 inhibits or insulin\n    * any drugs used specifically to induce muscle growth\u002Fhypertrophy or augment exercise-induced muscle hypertrophy\n    * Pain\u002FInflammation: narcotics and narcotic receptor agonists, regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen, muscle relaxants ≥2 days per week\n    * Other: chronic systemic antimicrobials (antibiotic, antiviral, antifungal, antiparasite, etc.) for any reason, high-potency topical steroids if ≥10% surface area using rule of 9s, continuous\u002Fchronic use of antibiotics or other anti-infectives for treatment or prevention, monoclonal antibodies, anti-rejection medications\u002Fimmune suppressants. Participants can be re-screened after a 3 month washout period if antimicrobial use is only used acutely \\\u003C 2 weeks.\n32. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete the study.","30 Years",{"count":179,"type":21},36,"OBSERVATIONAL","The purpose of this study is to find new signs or signals in muscle cells that can help us understand when the body isn't responding well to insulin (a condition called insulin resistance).",[29],"2026-08-10",{"date":185,"type":41},"2026-08-12",{"date":187,"type":41},"2026-06-11",{"date":189,"type":21},"2028-12",{"name":191,"class":48},"AdventHealth Translational Research Institute",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":12,"sex":116,"minAge":118,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":216,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":49},"100648817","prebiotic-inulin-for-late-reproductive-individuals-100648817","NCT07724522","Prebiotic Inulin for Late-Reproductive Individuals","A Placebo Randomized Cross-Over Controlled Trial of Inulin Supplementation to Improve Cardiometabolic, Gut, and Vaginal Microbiome in Perimenopausal Women","PILI","Inclusion Criteria:\n\n* Body mass index: 25 - 40 kg\u002Fm2;\n* Menstrual cycle irregularity (cycle length outside 21 - 35 days or variation \\> 7 days) or\u002Fand ≥ 2 skipped cycles and interval of ≥ 60 days of amenorrhea; with or without hot flashes or\u002Fand night sweats;\n* Weight stable within the last 3 months (body weight fluctuations within the 5% of their habitual body weight);\n* Spending ≥ 6 hours sitting;\n* \\\u003C 150 minutes per week (50 minutes per day, 3 days per week OR 30 minutes per day, 5 days per week) of moderate to vigorous structured physical activity (i.e., planned intentional physical activity, not incidental movement).\n\nExclusion Criteria:\n\n* Recent antibiotic use oral or vaginal (≥ 6months);\n* Diagnosed with any chronic disease (e.g., any gastrointestinal condition like IBD, type 2 diabetes, or cancer);\n* Prescription of hormone replacement therapy, hormonal contraceptives, probiotics, GLP-1 medications, or weight loss medications\n* Smoking;\n* Recent blood donation (within the past 8-12 weeks);\n* Significant weight changes (≥5%) in the last 4 weeks;\n* Use of dietary supplements (unless discontinued 4 weeks prior);\n* Participants taking long-term, stable medications for chronic conditions such as hypertension or hyperlipidemia will not be excluded if their medication regimen has been unchanged for at least 2 years, as these treatments are part of their usual health status. Recent medication changes (within the past 6 months), initiation of new prescriptions, or use of medications known to affect metabolic, vascular, vaginal, hormonal, or gastrointestinal function will result in exclusion.\n* Fructose intolerance.","55 Years",{"count":202,"type":21},27,[24],"This study aims to evaluate the effects of 2 weeks of inulin supplementation in perimenopausal women with overweight or obesity. The primary questions this study seeks to answer are:\n\n1. Does 2 weeks of inulin supplementation alter the gut and vaginal estrobolome compared with placebo?\n2. Does 2 weeks of inulin supplementation affect cardiovascular health compared with placebo?\n3. Does 2 weeks of inulin supplementation affect skeletal muscle health compared with placebo?\n\nResearchers will compare inulin with a placebo (a similar-looking supplement that does not contain inulin) to determine whether inulin influences gut and vaginal microbial function, cardiovascular health, and skeletal muscle health during the perimenopausal transition.\n\nParticipants will:\n\n* Take either inulin or a placebo for 2 weeks, followed by a 2- to 4-week washout period, and then switch to the other supplement for an additional 2 weeks.\n* Attend 8 study visits over approximately 12 to 16 weeks for assessments and sample collection.\n* Complete weekly phone calls to monitor symptoms, supplement adherence, and dietary intake.\n* Wear a Fitbit device throughout the study to monitor physical activity.",[93,206,207,208,209,210,211,212,213,214,215,29],"Perimenopausal Women","Prebiotics","Inulin","Muscle, Skeletal","Cardiovascular Diseases (CVD)","Microbiota","Gastrointestinal Microbiome","Dietary Fiber","Women Health","Vascular Health",[217,218,219,99,65,220,221,222,223,224,225,208,215],"Perimenopause","Nutrition","Menopause transition","Cardiometabolic Health","Vascular function","Randomized Controlled Trial","Gut microbiome","Vaginal microbiome","Supplements","2026-08-07",{"date":228,"type":41},"2026-08-11",{"date":230,"type":41},"2026-08-01",{"date":232,"type":21},"2028-02",{"name":234,"class":48},"George Washington University",{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":245,"conditions":246,"keywords":250,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":4,"leadSponsor":260,"locationsCount":49},"100143840","study-of-the-effect-of-innate-on-the-inflammatory-response-to-endotoxin-100143840","NCT01143480","Study of the Effect of Innate on the Inflammatory Response to Endotoxin","Study of the Effect of Innate Immunity on the Inflammatory Response to Endotoxin","* INCLUSION CRITERIA:\n* Male or female 18 years of age or older\n* Participants must be able to understand and provide written informed consent to participate in the study\n* Participants must be able to travel to the CRU\n* Willing and able to fast after midnight the night prior to their study appointment.\n* Healthy participants as defined by the International Red Cross guidelines (Healthy means that an individual feels well and can perform normal activities. If the individual has a chronic condition such as diabetes or high blood pressure, healthy also means that they are being treated and the condition is under control).\n\nEXCLUSION CRITERIA:\n\n* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 5 days prior to enrollment visit (e.g., Motrin, ibuprofen, naproxen, and Advil)\n* Use of acetaminophen (Tylenol) within 5 days prior to enrollment visit\n* Use of cholesterol lowering drugs (statins) within 30 days prior to enrollment visit (e.g., Zocor, Mevacor, Lipitor, and Crestor)\n* Use of immunosuppressants or other immune-modifying drugs \\[e.g., Rituxan, Humira, Enbrel, Cyclosporin (Neoral, Sandimmune, and SangCya), and Azathioprine (Imuran)\\], Monoclonal antibodies \\[e.g., infliximab (Remicade)\\], and corticosteroids (e.g., prednisone, prednisolone and dexamethasone)\n* Current treatment for cancer with chemotherapy or radiation\n* Confirmed or suspected immunosuppressive or immunodeficient condition\n* GI or respiratory Illness within 5 days prior to enrollment visit, including cold or allergies\n* Smoked tobacco, chewed tobacco or used electronic cigarettes within 2 weeks prior to enrollment visit (for participants who provide a urine specimen, this will be defined by urine cotinine \\>200 ng\u002FmL at visit)\n* Alcohol consumption greater than 2 standard drinks (1 standard drink contains 15 g of ethanol) per day within the last 24 hours prior to the enrollment visit\n* Body weight \\\u003C 50 kg (\\\u003C110 lbs)\n* Temperature \\> 37.6 C; blood pressure \\\u003C 90\u002F50 mm Hg or \\> 170\u002F95 mm Hg; pulse rate \\\u003C 50 or \\>100 beats\u002Fminute\n* Pregnant or suspected pregnancy\n* Chronic Kidney Disease\n\nThe PI may review medication use on a case by case basis and make a medical determination on the participant s eligibility. In these cases, the PI determination will be documented in the participant s chart.","100 Years",{"count":244,"type":21},725,"Background:\n\n\\- Innate immunity is the process by which white blood cells and other parts of the immune system sense and respond to potential infections by causing an inflammation. Researchers are interested in studying how the body responds to certain environmental factors, and whether the body s response can contribute to chronic illnesses or diseases such as asthma and certain types of cancers.\n\nObjectives:\n\n\\- To examine how specific genes and proteins in blood cells respond to environmental exposures.\n\nEligibility:\n\n\\- Healthy volunteers between 18 and 45 years of age.\n\nDesign:\n\n* The study will involve one visit of 45 to 60 minutes.\n* Participants will be screened with a brief physical examination and finger stick to determine if they are eligible to donate blood for the study, and will complete a questionnaire about any medications or other drugs (e.g., cigarettes) they may be taking.\n* Participants will provide a blood sample for research purposes.",[247,248,153,29,249],"Asthma","Atherosclerosis","Cancer",[251,252,253,254,255],"Endotoxin","Innate Immunity","Natural History","Healthy Volunteer","HV","2026-08-06",{"date":226,"type":41},{"date":259,"type":41},"2012-07-30",{"name":261,"class":77},"National Institute of Environmental Health Sciences (NIEHS)",{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":57,"sex":17,"minAge":270,"maxAge":18,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":280,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":295,"locationsCount":297},"100610097","a-sensory-strategy-to-cut-sugary-beverages-in-africanamerican-and-latine-adolescents-100610097","NCT07223151","A Sensory Strategy to Cut Sugary Beverages in African\u002FAmerican and Latine Adolescents","Trading Sugar for Sparkles in Adolescents, A Sensory Approach for Reducing Added Sugar From Sweetened Beverages","SPARKLE","Inclusion Criteria:\n\n* Adolescents ages 12 to 18 who display a \"sweet-liker\" pattern, characterized by a preference for higher concentrations of sugar in beverages, specifically identifying 0.3M (10.3% sucrose) or above as their most liked sample.\n* Adolescents consumes sugar-sweetened soda greater than or equal to 2 times per week. Adolescents must also indicate a willingness to drink study beverages; not currently dieting\u002Fchanging diet.\n\nExclusion Criteria:\n\n* Adolescent participant is pregnant, since pregnancy affects taste perception\n* Participant is allergic or intolerant to the items we are testing.\n* Adolescent with type 1 or type 2 diabetes (self-declared or detected at screening visit through fasting glucose)\n* Use of GLP-1 receptor agonists intended for weight loss.","12 Years",{"count":272,"type":21},63,[24],"The goal of this clinical trial is to test whether replacing sugary sodas with unsweetened, flavored sparkling waters can reduce added sugar intake and improve health in Black\u002FAfrican American and Latine adolescents with obesity who prefer sweet-tasting beverages. The main questions it aims to answer are:\n\n* Does replacing sugary sodas with water change liking for sugary drinks, and water?\n* Do shifts in liking for sweetness lead to improved diet quality and cardiometabolic health?\n\nResearchers will compare replacing sugary sodas with one of three alternative beverages: unsweetened sparkling water, plain water, and beverages with gradually reduced sugar to determine which strategy is most effective.\n\nParticipants will:\n\n* Replace sugary sodas with study drinks for 4 weeks\n* Complete taste tests to measure their liking for and sensory experience of sweetness over 8-weeks\n* Provide dietary recalls, body measurements, and blood samples over 8-weeks",[276,277,278,29,279],"Obesity, Adolescent","Dietary Sugars","Taste Perception","Feeding Behavior",[65,281,282,278,29,283,284,285,286,287,288,289,222],"Adolescent","Sugar-Sweetened Beverages","Sweet Taste Preference","Latine Youth","African American Youth","Dietary Intervention","Beverage Replacement","Sugar Reduction","Sensory Evaluation","2026-08-04",{"date":256,"type":41},{"date":293,"type":41},"2025-07-25",{"date":135,"type":21},{"name":296,"class":48},"Nana Gletsu Miller",3,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":57,"sex":17,"minAge":145,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":307,"conditions":308,"keywords":310,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":49},"100579158","a-comparison-of-neuromuscular-recruitment-in-trained-and-untrained-adults-100579158","NCT06820658","A Comparison of Neuromuscular Recruitment in Trained and Untrained Adults","Inclusion Criteria\n\n* Participant must have a BMI between 18.5 and 38\n* Participant be aged between 60 and 85\n* Regularly exercises at least 5 days a week a minimum of 30 minutes per day.\n* Engages in less than 2 days of exercise less than 30 minutes each day.\n* Participant must use the Mayo Clinic patient online portal.\n* Participant must be able to understand English without the need of an interpreter.\n* Must be willing to be contacted for research\n* Participant must be willing and capable to provide consent.\n* Participants shall be generally healthy as deemed acceptable by the principal investigator\n* Men and women will be participant in this study. Women cannot be pregnant during this study.\n\nExclusion Criteria:\n\n* Surgical History - Gastric surgery, pacemaker placement, weight loss surgery, metabolic and obstetric surgery.\n* Smokers will be excluded from the study.\n* Medications: Insulins, common diabetic drugs, anti-hyperglycemic drugs, beta blockers cardiac selective, beta-blockers noncardiac selective, oral steroids, opioids anti-depressants, and hormones\n* Conidiations and Diagnosis: Disorder of coronary artery, hepatic failure, gastroparesis, disorder of the adrenal gland, drug related disorders, substance abuse, malignant neoplastic disease, psychotic disorders, disorder of skeletal muscle, finding of brain, chronic kidney disease, renal failure syndrome, disorder of pulmonary circulation, cerebrovascular disease, neuro developmental disorder, disorder of immune function, disorder of central nervous system.\n* Participants are not to have an abnormal value as part of a lipid panel within the past 6 months.\n* Participant will be excluded if they have recreational drug use or a history of alcohol abuse\n* Inability or unwillingness of individual or legal guardian\u002Frepresentative to give written informed consent.\n* Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.\n* Participant will be excluded if they have epilepsy.\n* Participant will be excluded if they have cranial metal\u002Fdevice implants\n* Participant will be excluded if they are pregnant","85 Years",{"count":306,"type":21},80,"The objective of the study is to use neurological techniques to obtain quantitative measurements of nervous system control of skeletal muscle activity in adults aged 60-85 who are either long-term resistance exercisers or who are untrained.",[309,29],"Healthy",[311,312],"neuromuscular","transcranial magnetic stimulation","2026-08-03",{"date":315,"type":41},"2026-08-05",{"date":317,"type":41},"2025-02-26",{"date":319,"type":21},"2028-10-01",{"name":321,"class":48},"Mayo Clinic",{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":17,"minAge":270,"maxAge":18,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":347},"100575313","effect-of-tele-exercise-on-cardiorespiratory-fitness-in-paediatrics-100575313","NCT06770660","Effect of Tele-exercise on Cardiorespiratory Fitness in Paediatrics","Evaluating the Effectiveness of Telemedicine-based Exercise Programme in Improving Cardiorespiratory Fitness in Asian Paediatric Population: a Randomised Controlled Trial","Inclusion Criteria:\n\n* 12 to 17 years (secondary school students)\n* able to participate in school physical education lessons\n\nExclusion Criteria:\n\n* less than 12 years or 18 years and older (non-secondary school students)\n* has medical or musculoskeletal condition(s) preventing participation in school physical education lessons or exercise",{"count":330,"type":21},122,[24],"The goal of this clinical trial is to learn if telemedicine exercise programme can improve the cardiorespiratory fitness (how well your body delivers oxygen to muscles and organs) and insulin resistance in Asian children with low cardiorespiratory fitness levels. The main questions it aims to answers are:\n\n* Does telemedicine exercise programme improve the number of 20-metre laps the participant is able to run?\n* Does telemedicine exercise programme improve the insulin sensitivity using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) formula?\n\nResearchers will compare the telemedicine exercise programme to current active lifestyle programme (e.g., daily step count monitoring) to see if telemedicine exercise programme is more effective in improving cardiorespiratory fitness.\n\nParticipants will:\n\n* participate in weekly telemedicine exercise programme or adhere to current active lifestyle recommendations through daily step count reporting for 10 weeks\n* visit the clinic for pre- and post-programme cardiorespiratory fitness assessments and blood taking",[334,29],"Cardiorespiratory Fitness",[336,337,338,34],"paediatric","cardiorespiratory fitness","telemedicine",{"date":315,"type":41},{"date":341,"type":41},"2025-05-02",{"date":343,"type":21},"2027-12",{"name":345,"class":346},"KK Women's and Children's Hospital","OTHER_GOV",2,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":12,"sex":116,"minAge":18,"maxAge":356,"enrollmentInfo":357,"targetDuration":358,"studyType":180,"phases":4,"briefSummary":359,"conditions":360,"keywords":362,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":371,"leadSponsor":373,"locationsCount":4},"100649507","evaluation-of-serum-preptin-levels-in-patients-with-polycystic-ovary-syndrome-100649507","NCT07736079","Evaluation of Serum Preptin Levels in Patients With Polycystic Ovary Syndrome","Evaluation of Serum Preptin Levels and Their Relationship With Insulin Resistance in Patients With Polycystic Ovary Syndrome","PREPTIN-PCOS","Inclusion Criteria:\n\n* Female participants aged 18-45 years\n* Diagnosis of PCOS according to Rotterdam criteria\n* BMI \\\u003C30 kg\u002Fm²\n* No PCOS treatment during the previous 6 months\n* Not pregnant or breastfeeding\n* No active infection\n* No rheumatologic or inflammatory disease\n* No chronic systemic disease\n* Written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years or \\>45 years\n* Pregnancy or breastfeeding\n* PCOS treatment within the previous 6 months\n* Active infection\n* Rheumatologic or inflammatory disease\n* Hypertension\n* Diabetes mellitus\n* Chronic kidney disease\n* Refusal to participate","45 Years",{"count":60,"type":21},"12 Weeks","Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders in women of reproductive age and is strongly associated with insulin resistance and metabolic dysfunction. Preptin is a pancreatic peptide co-secreted with insulin and has been implicated in glucose metabolism and insulin resistance. However, limited data exist regarding serum preptin levels in patients with PCOS.\n\nThe aim of this study is to evaluate serum preptin levels in women diagnosed with PCOS and to investigate the relationship between preptin levels and insulin resistance parameters.",[361,29],"Polycystic Ovary Syndrome (PCOS)",[363,29,364,365,366],"Polycystic Ovary Syndrome","Preptin","Biomarker","Hyperandrogenism","2026-07-28",{"date":369,"type":41},"2026-07-30",{"date":369,"type":21},{"date":372,"type":21},"2026-09-30",{"name":374,"class":48},"GÜLDEN ANATACA",{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":383,"targetDuration":385,"studyType":180,"phases":4,"briefSummary":386,"conditions":387,"keywords":390,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":49},"100649406","evaluation-of-neuregulin-4-nrg4-levels-in-obese-and-non-obese-patients-with-type-2-diabetes-mellitus-100649406","NCT07734558","Evaluation of Neuregulin-4 (NRG4) Levels in Obese and Non-Obese Patients With Type 2 Diabetes Mellitus","Evaluation of the Relationship Between Serum Neuregulin-4 (NRG4) Levels, Obesity Status, and Antidiabetic Treatment Regimens in Patients With Type 2 Diabetes Mellitus: A Prospective Observational Study","NRG4-T2DM","Inclusion Criteria:\n\n* Age 18-65 years\n* Newly diagnosed treatment-naïve T2DM\n* T2DM treated for at least 6 months\n* BMI \\>30 kg\u002Fm²\n* BMI \\\u003C25 kg\u002Fm²\n* No pregnancy\n* No breastfeeding\n* No active infection\n* No inflammatory disease\n* Written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Pregnancy\n* Breastfeeding\n* Active infection\n* Rheumatologic disease\n* Refusal to participate",{"count":384,"type":21},125,"1 Day","This prospective observational study aims to evaluate serum Neuregulin-4 (NRG4) concentrations in obese and non-obese adults with Type 2 Diabetes Mellitus (T2DM) and to investigate their association with obesity status, insulin resistance, and different antidiabetic treatment regimens. Participants will be categorized into five predefined groups according to obesity status and treatment regimen, including SGLT2 inhibitor users, non-SGLT2 oral antidiabetic therapy users, SGLT2 combination therapy users, newly diagnosed treatment-naïve patients, and healthy controls. Clinical, anthropometric, and laboratory parameters including fasting plasma glucose, HbA1c, estimated glomerular filtration rate (eGFR), body mass index, waist circumference, waist-to-hip ratio, and serum NRG4 concentrations will be evaluated. The study aims to determine whether NRG4 may serve as a novel biomarker reflecting metabolic status and treatment response in patients with T2DM.",[388,389,29],"Type 2 Diabetes Mellitus (T2DM)","Obesity Type 2 Diabetes Mellitus",[391,392,393,65,394],"Neuregulin-4","NRG4","Type 2 Diabetes Mellitus","Adipokine","2026-07-27",{"date":397,"type":41},"2026-07-29",{"date":399,"type":21},"2026-06",{"date":401,"type":21},"2026-12-30",{"name":374,"class":48},{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":17,"minAge":410,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":419,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":49},"100648951","impact-of-preoperative-oral-carbohydrate-loading-on-insulin-resistance-in-pediatric-cardiac-surgery-patients-100648951","NCT07729280","Impact of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Cardiac Surgery Patients","The Effect of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 2-16 years.\n* ASA physical status 2 or 3\n* Good tolerance of enteral feeding\n\nExclusion Criteria:\n\n* History of type 1 diabetes mellitus.\n* History of thyroid insufficiency treated with thyroid medication.\n* History of adrenal insufficiency treated with corticosteroids.\n* History of gastroesophageal reflux disease.\n* Patients receiving preoperative parenteral nutrition.\n* Emergency or urgent cardiac surgery.","2 Years","16 Years",{"count":413,"type":21},44,[24],"Surgical stress and preoperative fasting can induce insulin resistance, characterized by impaired cellular response to insulin and resulting hyperglycemia. In pediatric patients undergoing cardiac surgery, this metabolic stress response may negatively affect postoperative recovery. Although preoperative oral carbohydrate loading, defined as administering a carbohydrate-rich beverage before surgery rather than prolonged fasting, has demonstrated efficacy in reducing postoperative insulin resistance in adults, evidence supporting its use in pediatric cardiac surgery remains limited.\n\nThis randomized controlled trial aims to determine whether preoperative oral carbohydrate loading reduces perioperative insulin resistance, as measured by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), in pediatric patients undergoing cardiac surgery. The study will compare outcomes between children who receive an oral carbohydrate beverage prior to surgery and those who follow standard preoperative fasting protocols.",[417,29,418],"Cardiac Surgery","Pediatric Cardiac Surgery",[420,421,96,422],"Cardiac surgery","Carbohydrate loading","Glycemic variability","2026-07-24",{"date":395,"type":41},{"date":426,"type":21},"2026-08-25",{"date":428,"type":21},"2026-11-01",{"name":430,"class":48},"Rifdhani Fakhrudin Nur",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":57,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":437,"targetDuration":4,"studyType":22,"phases":439,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":49},"100641635","early-phase-1-interplay-of-central-and-peripheral-vascular-effects-of-insulin-in-obesity-100641635","NCT07653464","Interplay of Central and Peripheral Vascular Effects of Insulin in Obesity","Inclusion Criteria:\n\n* 18 to 65 years of age\n\nIndividuals with obesity and comorbid IR\n\n* BMI 30-45 kg\u002Fm2\n* Waist circumference ≥102 cm (men) or ≥88 cm (women)\n* HOMA-IR ≥2.5\n\nHealthy normal weight adults\n\n* BMI 18-25 kg\u002Fm2\n* Waist circumference \\\u003C94 cm (men) and \\\u003C80 cm (women)\n* HOMA-IR \\\u003C2\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding\n* Unable to provide consent\n* Diabetes or polycystic ovarian syndrome\n* Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease, stroke\n* Nerve\u002Fneurologic disease\n* Uncontrolled hypertension (systolic blood pressure \\>180 mmHg and\u002For diastolic blood pressure \\>100 mmHg)\n* Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)\n* Current smoking, tobacco, nicotine use\n* Use of pharmacological therapy for weight loss\n* Body weight change \\>10% within the last 6 months\n* Adherence to \\>150 min\u002Fweek of moderate-to-vigorous physical activity\u002Fexercise\n* Participation in any other research study or medical procedure involving significant ionizing radiation exposure in the past 12 months\n* Claustrophobia\n* Non-MRI compatible metal implants",{"count":438,"type":21},64,[440],"EARLY_PHASE1","Determine the impact of obesity with insulin resistance on the neurovascular response to brain insulin stimulation.",[125,29],{"date":367,"type":41},{"date":445,"type":21},"2026-10",{"date":447,"type":21},"2032-06",{"name":449,"class":48},"University of Missouri-Columbia",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":57,"sex":17,"minAge":458,"maxAge":200,"enrollmentInfo":459,"targetDuration":4,"studyType":22,"phases":461,"briefSummary":462,"conditions":463,"keywords":466,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":476,"locationsCount":49},"100510997","small-extracellular-vesicles-and-insulin-action-100510997","NCT05933707","Small Extracellular Vesicles and Insulin Action","Effect of Small Extracellular Vesicles From Adipose Tissue on Insulin Action","SEV","Inclusion Criteria:\n\n* Metabolically healthy lean subjects must have a BMI ≥18.5 and ≤24.9 kg\u002Fm²; Subjects with obesity must have a BMI ≥30.0 and ≤50.0 kg\u002Fm²\n* Metabolically healthy lean and people with metabolically healthy obesity must have intrahepatic triglyceride (IHTG) content ≤5%; fasting plasma glucose concentration \\\u003C100 mg\u002Fdl, 2-hr oral glucose tolerance plasma glucose concentration \\\u003C140 mg\u002Fdl, hemoglobin A 1C (HbA1c) ≤5.6% and HOMA-IR \\\u003C2.5.\n* People with metabolically unhealthy obesity must have intrahepatic triglyceride (IHTG) content ≥5.6%; HOMA-IR ≥2.5, and HbA1c 5.7%-6.4%, or fasting plasma glucose concentration ≥100 mg\u002Fdl, or 2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≥140 mg\u002Fdl.\n\nExclusion Criteria:\n\n* History of diabetes, liver disease other than NAFLD or other serious diseases,\n* Consume excessive amounts of alcohol (\\>21 units\u002Fweek for men and \\>14 units\u002Fweek for women),\n* Take medications that could affect the study outcome measures, engage in regular exercise (\\>120 min\u002Fweek),\n* Are pregnant or lactating","25 Years",{"count":460,"type":21},72,[24],"The goals of this research study are to: 1) understand why some people with obesity are protected from developing conditions such as type 2 diabetes and cardiovascular disease while others are more likely to develop obesity-related conditions; 2) assess the effect of small extracellular vesicles (sEVs also called exosomes), obtained from human participants, on metabolic function in cultured cells and in mice.",[65,29,464,465],"Metabolically Healthy Obesity","Obesity, Metabolically Benign",[65,467,468,469],"Weight Loss","Exosomes","Extracellular vesicles","2026-07-15",{"date":472,"type":41},"2026-07-17",{"date":474,"type":41},"2023-06-14",{"date":106,"type":21},{"name":477,"class":48},"Washington University School of Medicine",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":57,"sex":17,"minAge":484,"maxAge":485,"enrollmentInfo":486,"targetDuration":4,"studyType":22,"phases":488,"briefSummary":489,"conditions":490,"keywords":492,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":501,"locationsCount":503},"100647536","effects-of-exercise-sequence-and-meal-sequence-on-weight-management-among-children-and-adolescents-with-overweight-or-obesity-the-step-trial-100647536","NCT07712068","Effects of Exercise Sequence and Meal Sequence on Weight Management Among Children and Adolescents With Overweight or Obesity: The STEP Trial","Inclusion Criteria:\n\nTo be included in the study, participants must be between 10 and 17 years old and have a Body Mass Index equal to or greater than the 95th percentile for their age and sex, which meets the Chinese screening standard for overweight and obesity in school-aged children and adolescents. Additionally, participants and their legal guardians must have signed a service contract and paid in full for the commercial weight loss camp service before signing the study consent form. Participants must possess basic communication skills and the ability to comply with study instructions. They must also pass the mandatory pre-camp exercise risk medical screening, which includes blood and urine tests, blood pressure, resting electrocardiograms, and exercise electrocardiograms. Finally, participants and their legal guardians must provide dual signed informed consent.\n\nExclusion Criteria:\n\nIndividuals are excluded from the study if they have been diagnosed with secondary obesity or genetic obesity syndromes. Furthermore, individuals who have taken medications affecting body weight or bone metabolism within the past three months are not eligible to participate. The study also excludes individuals with clinically diagnosed eating disorders, depression, or other severe psychiatric illnesses. Individuals who are unable or unwilling to cooperate with venous blood sampling or other biological sample collections are excluded as well. Finally, individuals with severe cardiopulmonary dysfunction, severe scoliosis, or other clear medical contraindications to exercise cannot participate in the trial.","10 Years","17 Years",{"count":487,"type":21},480,[24],"The goal of this clinical trial is to learn how the order of exercise and the order of eating food affect weight management in overweight and obese children and adolescents. The main questions it aims to answer are whether doing aerobic or anaerobic exercise first changes weight loss results, and whether eating vegetables and proteins before carbohydrates improves health outcomes compared to a standard diet. Furthermore, the study asks how the exercise order and eating order work together to affect weight and health. Researchers will compare four different groups to see if these specific exercise and eating orders work better to treat obesity. Participants will stay at a closed weight loss camp for 28 days and do daily aerobic and anaerobic exercises in a randomly assigned order. They will eat meals in either a strict order, consuming vegetables and proteins first, or a standard order. Throughout the trial, participants will give blood, urine, stool, saliva, and sweat samples for lab tests, while also checking their body weight, body composition, and heart rate. Finally, they will answer surveys about their diet, physical activity, hunger, and tiredness.",[93,29,491],"Inflamation",[493,494,495],"child and adolescent obesity","obesity & overweight","child and adolescent insulin resistance","2026-07-13",{"date":472,"type":41},{"date":499,"type":21},"2026-07",{"date":372,"type":21},{"name":502,"class":48},"Peking University",9,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":17,"minAge":117,"maxAge":145,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":519,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":49},"100645658","kodo-millet-porridge-and-its-effects-on-gut-health-and-metabolic-syndrome-100645658","NCT07703371","Kodo Millet Porridge and Its Effects on Gut Health and Metabolic Syndrome","Impact of Dietary Fiber-Rich Kodo Millet Porridge Supplementation on Gut Microbiome and Metabolic Syndrome","KMGMS","Inclusion Criteria\n\n* Adults aged 20-60 years.\n* Willingness to provide informed consent.\n* Willingness to consume Kodo millet porridge daily for 12 weeks.\n* No planned changes in diet or physical activity during the study.\n* Overweight or obese (BMI ≥ 25 kg\u002Fm²), placing them at risk for metabolic disorders.\n\nExclusion Criteria\n\n* Known allergies to millet or any porridge ingredients.\n* Individuals who are taking on-counter dietary fiber and probiotics supplements\n* History of any chronic gastrointestinal diseases (e.g., IBD, gastritis, irritable bowel syndrome).\n* Pregnant or lactating women.\n* Antibiotic use in last 3 months.\n* Alcohol abuse, more than 2 drink per day\n* Presence and usage of medications for any serious chronic illnesses, including uncontrolled diabetes (HbA1c \\> 9), cardiovascular disease (aldosterone antagonists, alpha blockers, alpha-beta blockers, anticoagulants, antiplatelets, angiotensin-converting enzyme inhibitors, angiotensin 2 receptor blockers, beta blockers, calcium channel blockers, diuretics, digoxin) , renal disease, neurological or mental disorders, coagulation disorders, and cancer.",{"count":513,"type":21},50,[24],"Dietary fiber are components in foods that are not digested by human gastrointestinal enzymes (alpha amylase and alpha glucosidase) but are instead broken down and fermented by gut microbes. The byproducts generated during fermentation in the large intestine, primarily short-chain fatty acids (SCFA), bile acids, indoles, and their derivatives, circulate through the circulatory system to the liver, lungs, brain, adipose tissue, and muscles, where they modulate metabolism (suppress lipogenesis and alleviate insulin resistance) and immune function. Individuals who are overweight or obese frequently exhibit gut dysbiosis, characterized by lower SCFA producing commensals. This condition predisposes them to metabolic disorders such as insulin resistance, dyslipidemia, and hypertension, and contributes to conditions including type 2 diabetes, cardiovascular disease, and metabolic dysfunction-associated steatotic liver disease. Preclinical and clinical research have demonstrated that the consumption of fiber-rich foods maintains or restores gut microbiota health and diminishes the risk of metabolic disorders. Kodo millet (Paspalum scrobiculatum), a small millet, is rich in dietary fiber and we have developed a palatable kodo millet porridge beverage enriched with polyphenols and dietary fiber. The purpose of this study is to examine the effects of consuming Kodo millet porridge beverage as a nutritional supplement for 3 months, on gut microbiome richness (composition and diversity) and metabolic health in overweight or obese people.",[93,153,517,29,518],"Gut Dysbiosis","Dyslipidemia",[520,213,521,522,523,153,65,517,518,524,525,526,527,528,529],"Kodo Millet","Gut Microbiome","Short-Chain Fatty Acids","16S rRNA Sequencing","Glycemia","Prebiotic","Small Millet","Porridge","Antioxidant","Inflammation","2026-07-11",{"date":532,"type":41},"2026-07-14",{"date":534,"type":41},"2026-06-01",{"date":536,"type":21},"2026-11-16",{"name":538,"class":48},"JSS MEDICAL COLLEGE, JSS ACADEMY OF HIGHER EDUCATION AND RESEARCH",{"id":540,"slug":541,"hasResults":12,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":548,"briefSummary":549,"conditions":550,"keywords":552,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":559,"leadSponsor":561,"locationsCount":297},"100645460","diabetes-glycemic-assessment-in-newly-confirmed-episodes-100645460","NCT07690163","DIabetes GLycemic Assessment in Newly Confirmed Episodes","Evaluation of Continuous Glucose Monitoring Systems for Optimizing Glycemic Control in Patients With Newly Diagnosed Type 2 Diabetes: A Postmarketing Clinical Analysis","DI-GLANCE","Inclusion Criteria:\n\n* Age of 18 years and older.\n* Newly diagnosed Type 2 Diabetes Mellitus according to ADA (American Diabetes Association) criteria (Fasting Plasma Glucose ≥ 7.0 mmol\u002FL, or 2-hour Post-Prandial Glucose ≥ 11.1 mmol\u002FL during OGTT, or HbA1c ≥6.5%).\n* Time since the initial diagnosis of T2D must not exceed 3 months ( less 90 days) at the time of screening.\n* HbA1c level between 6.5% and 9.5% (inclusive) at screening.\n* Patients may be lifestyle-controlled or receiving any stable non-insulin anti-diabetic therapy (including Metformin, SGLT2 inhibitors, GLP-1 receptor agonists, DPP-4 inhibitors, or Sulfonylureas) as monotherapy or combination therapy.\n* Ability to provide written informed consent and willingness to adhere to the study protocol and follow-up schedule.\n\nExclusion Criteria:\n\n* Diagnosis or suspicion of Type 1 Diabetes, Latent Autoimmune Diabetes in Adults (LADA) (e.g., positive anti-GAD antibodies if tested), or secondary types of diabetes (e.g., pancreatic or drug-induced).\n* Any prior or current use of insulin therapy.\n* Severe microvascular or macrovascular complications (proliferative retinopathy, severe diabetic nephropathy with eGFR \\\u003C 45 mL\u002Fmin\u002F1.73m², diabetic foot ulcers, severe peripheral neuropathy).\n* Endocrine disorders (e.g., Itsenko-Cushing syndrome, acromegaly) that affect glycemia.\n* History of myocardial infarction, stroke, unstable angina, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) within the past 6 months.\n* Active malignancy, decompensated heart failure (NYHA Class III or IV), or chronic infectious diseases.\n* Pregnant or breastfeeding women, or women of childbearing potential not using highly effective contraception.\n* Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant.\n* Participation in another clinical study within the last 3 months.",{"count":306,"type":21},[24],"This is a prospective, open-label, randomized controlled trial involving 80 adult patients with newly diagnosed T2DM (diagnosed within the last 3 months) recruited at the Bogomolets National Medical University. Participants may be lifestyle-controlled or receiving stable non-insulin anti-diabetic medications. Participants will be randomized in a 1:1 ratio to either the Real-Time Continuous Glucose Monitoring group (CGM group) or the control group (standard Self-Monitoring of Blood Glucose \\[SMBG\\] using conventional glucometers).\n\nThe gathered data will help determine whether the real-time visual feedback provided by CGM systems superiorly improves glycemic variability, optimizes metabolic parameters, and enhances patient adherence to lifestyle interventions and pharmacological treatment compared to conventional SMBG methods in the early stages of T2D.",[551,389,93,29],"Type 2 Diabetes (T2DM)",[553,554,34,555,556],"obesity","continuous glucose monitoring","traditional glycemia self-monitoring","type 2 diabetes",{"date":532,"type":41},{"date":470,"type":21},{"date":560,"type":21},"2027-03-31",{"name":562,"class":48},"Nazarii Kobyliak",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":57,"sex":17,"minAge":570,"maxAge":18,"enrollmentInfo":571,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":49},"100516659","understanding-metabolism-and-inflammation-risks-for-diabetes-in-adolescents-100516659","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","14 Years",{"count":572,"type":21},175,"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.",[92,29,65,575,576],"Metabolic Disease","PreDiabetes","2026-07-10",{"date":496,"type":41},{"date":580,"type":41},"2023-09-06",{"date":582,"type":21},"2027-09",{"name":584,"class":48},"University of Michigan",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":17,"minAge":177,"maxAge":58,"enrollmentInfo":592,"targetDuration":4,"studyType":22,"phases":594,"briefSummary":595,"conditions":596,"keywords":603,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":49},"100646888","effectiveness-of-supervised-and-unsupervised-mhealth-based-exercise-interventions-on-clinical-outcomes-in-adults-with-type-2-diabetes-and-obesity-within-a-primary-care-context-100646888","NCT07685080","\"Effectiveness of Supervised and Unsupervised mHealth-based Exercise Interventions on Clinical Outcomes in Adults With Type 2 Diabetes and Obesity Within a Primary Care Context\"","Effectiveness of Supervised and Unsupervised mHealth-based Exercise Interventions on Clinical Outcomes in Adults With Type 2 Diabetes and Obesity Within a Primary Care Context: a Randomized Controlled Trial Protocol","Inclusion Criteria:\n\n* Diagnosed with both type 2 diabetes mellitus and obesity\n* Aged between 30 and 65 years\n* Body Mass Index (BMI) between 30 and 40 kg\u002Fm²\n* Glycated hemoglobin (HbA1c) greater than 6.5% (48 mmol\u002Fmol)\n* Fasting plasma or capillary blood glucose equal to or greater than 126 mg\u002FdL (7.0 mmol\u002FL)\n* Willing and able to provide informed consent to participate in the study\n* Available and willing to commit to a 20-week intervention period\n* Able and willing to use a smartphone and receive text messages\n* Able and willing to use a wearable device (smartwatch) and its associated mobile application\n\nExclusion Criteria:\n\n* Presence of any obesity-related comorbidity requiring clinical referral, including eating disorders, pseudotumor cerebri, sleep apnea, hypoventilation syndrome, or orthopedic problems that limit physical activity\n* Presence of psychiatric or medical conditions that would prevent compliance with the study protocol\n* History of a cardiovascular event (myocardial infarction, stroke, heart failure episode, or revascularization procedure) in the past 6 months\n* Presence of any medical condition that contraindicates participation in the proposed physical activity program\n* Current use of insulin therapy\n* Presence of orthopedic or other physical limitations that may interfere with the ability to exercise safely\n* Currently undergoing treatment for a malignant tumor (other than non-melanoma skin cancer)\n* Currently receiving treatment for, or diagnosed with, an eating disorder\n* Planned bariatric or weight-loss surgery (e.g., liposuction, gastric band, gastric bypass) within the next 5 months\n* Currently pregnant, given birth in the last 6 months, breastfeeding in the last 3 months, or actively planning a pregnancy in the next 5 months\n* Currently enrolled in, or planning to enroll in, a weight loss program during the study period\n* Lost more than 5 kilograms of body weight in the past 3 months",{"count":593,"type":21},126,[24],"Type 2 diabetes (T2D) and obesity are two of the most common chronic conditions worldwide, and they frequently occur together. Both conditions are closely linked to physical inactivity, which is currently recognized as a major risk factor for a wide range of diseases. Although structured exercise programs have shown benefits for people living with these conditions, maintaining long-term participation remains a significant challenge. The rise of mobile health (mHealth) technologies - such as smartphone apps and wearable devices - offers a promising new way to support people in becoming and staying more physically active.\n\nThis study aims to compare the effects of two different 20-week exercise intervention programs versus standard medical care in adults aged 30 to 65 who have been diagnosed with both T2D and obesity.\n\nParticipants will be randomly assigned to one of three groups:\n\nGroup 1 (Supervised Training): Participants will attend two in-person, supervised exercise sessions per week at a local sports facility, each lasting 60 minutes. Sessions will be led by a qualified trainer and will include strength, flexibility, and functional exercises. Participants will also receive weekly motivational text messages and group health coaching.\n\nGroup 2 (Unsupervised mHealth Training): Participants will follow the same exercise plan independently using a mobile application (ActiVital), which is part of the Andalusian Physical Activity Prescription Plan (PAPEF). They will receive their weekly training schedule through the app and will also receive text messages and group health coaching.\n\nGroup 3 (Control Group): Participants will continue with their usual medical care without any structured exercise program.\n\nAll participants across the three groups will be provided with a Fitbit Charge 6 wearable device to monitor daily physical activity and health indicators.\n\nThe study's central hypothesis is that both structured supervised exercise and app-guided unsupervised exercise will lead to meaningful improvements in clinical indicators - such as blood glucose levels, glycated hemoglobin (HbA1c), blood lipids, and blood pressure - as well as in body composition, physical fitness, sleep quality, and overall quality of life, when compared to standard care alone. It is also hypothesized that the mHealth approach will show particular benefits in terms of adherence, self-management, and scalability.\n\nA total of 126 participants will be recruited through the Primary Care Center of Osuna (Seville, Spain), with measurements taken before and after the 20-week intervention period. The study will help determine which type of exercise program is most effective and feasible for people managing both type 2 diabetes and obesity in a primary care setting.",[597,65,29,598,599,600,601,602],"Diabetes Mellitus, Type 2","Sedentary Behaviors","mHealth","Physical Exercise","Primary Care","Wearable Devices",[597,65,599,604,600],"Wearable","2026-07-02",{"date":607,"type":41},"2026-07-06",{"date":609,"type":21},"2026-10-01",{"date":611,"type":21},"2027-04-01",{"name":613,"class":48},"Escuela Universitaria de Osuna",{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":621,"targetDuration":4,"studyType":22,"phases":622,"briefSummary":623,"conditions":624,"keywords":627,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":633,"leadSponsor":635,"locationsCount":49},"100623974","phase-1-effect-of-insulin-lowering-on-lipogenesis-100623974","NCT07403604","Effect of Insulin Lowering on Lipogenesis","Human Models of Selective Insulin Resistance: Diazoxide, Part I","Inclusion Criteria:\n\n* Adults aged 18-65 years\n* Body mass index of 30-45 kg\u002Fm2\n* Able to understand written and spoken English and\u002For Spanish\n* Able to have pre-randomization screening labs drawn and study protocol initiated within 60 days of eligibility determination\n* Presence of uncomplicated metabolic dysfunction-associated steatotic liver disease (MASLD) by vibration-controlled transient elastography (VCTE)\n\n  * Steatosis score of S1-S3\n  * Fibrosis score of F0-F2 (Note that if VCTE result is available from within past 6 months, then do not have to repeat VCTE for study purposes)\n* Evidence of insulin resistance, represented by any or all of the following criteria:\n\n  * Meeting either of the American Diabetes Association's definitions for prediabetes or impaired fasting glucose (IFG) on screening labs:\n\n    * Prediabetes: Hemoglobin A1c 5.7-6.4%\n    * IFG: plasma glucose of 100-125 mg dL-1 after ≥ 8-h fast\n  * Homeostasis Model of Insulin Resistance (HOMA-IR) score ≥ 2.73\n* Fasting hyperinsulinemia (fasting insulin level ≥ 13 μU\u002FmL) on screening labs\n* Written informed consent (in English or Spanish) and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations.\n\nExclusion Criteria:\n\n* Unable to provide informed consent in English or Spanish\n* Concerns arising at screening visit (any of the following):\n\n  * Documented weight loss of ≥ 5.0% of baseline within the previous 3 months\n  * Abnormal blood pressure (including on treatment, if prescribed)\n\n    * Systolic blood pressure (SBP) \\\u003C 90 mm Hg or \\> 160 mm Hg, and\u002For\n    * Diastolic blood pressure (DBP) \\\u003C 60 mm Hg or \\> 100 mm Hg\n  * Resting heart rate \\\u003C 55 bpm or ≥ 110 bpm\n  * Abnormal screening electrocardiogram (or if on file, performed within previous 90 days)\n  * Laboratory evidence of diabetes mellitus:\n\n    * Hemoglobin A1c ≥ 6.5%, and\u002For\n    * Fasting plasma glucose ≥ 126 mg\u002FdL\n  * Positive qualitative serum β-human chorionic gonadotropin (β-hCG, i.e., pregnancy test) in women of childbearing potential\n  * Liver function abnormalities: transaminases (aspartate aminotransferase or alanine aminotransferase) \\> 3.0 x the upper limit of normal, and\u002For total bilirubin \\> 1.25 x the upper limit of normal\n  * Abnormal screening fasting triglycerides \\> 500 mg\u002FdL\n  * Abnormal screening serum electrolytes that are considered clinically significant according to the clinical judgment of the PI\n  * Creatinine equating to estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n  * Abnormal screening blood counts (any of the following):\n\n    * Hemoglobin \\\u003C 10 g\u002FdL\n    * White blood cell count below the lower limit of normal for sex\n    * Platelet count below the lower limit of normal for sex\n  * Uric acid level above the upper limit of normal\n* Reproductive concerns\n\n  * Women currently pregnant (tested by serum and\u002For urine β-hCG)\n  * Women currently breastfeeding\n* Concerns related to glucose metabolism\n\n  * History of having met any of the American Diabetes Association's definitions of diabetes mellitus (i.e., overt diabetes):\n\n    * Hemoglobin A1c ≥ 6.5%\n    * Plasma glucose ≥ 126 mg\u002FdL after 8-h fast\n    * Plasma glucose of ≥ 200 mg\u002FdL at 2 h after ingestion of a 75-g glucose load\n    * Random plasma glucose ≥ 200 mg\u002FdL associated with typical hyperglycemic symptoms, diabetic ketoacidosis, or hyperglycemic-hyperosmolar state\n  * History of gestational diabetes mellitus within the previous 5 years\n  * Use of antidiabetic medications except metformin within the 90 days prior to screening\n  * Clinical concern for absolute insulin deficiency (e.g., type 1 diabetes, pancreatic disease)\n* Concerns related to lipid metabolism\n\n  * Known diagnoses of familial hypercholesterolemia, familial combined hyperlipidemia, or familial hyperchylomicronemia\n  * Use of fibrates, prescription-strength omega-3 fatty acids, or high-dose niacin within the 90 days prior to screening:\n* Known, documented history (i.e., not to be newly screened\u002Ftested for study purposes), at the time of screening, of any of the following medical conditions:\n\n  * Pancreatic pathology, including but not limited to neoplasia, pancreatitis, pancreatectomy\n  * Cardiovascular disease (N.B. uncomplicated hypertension is not exclusionary)\n\n    * Atherosclerotic cardiovascular disease: stable or unstable angina, myocardial infarction, ischaemic or hemorrhagic stroke, or transient ischaemic attack, peripheral arterial disease (claudication), use of dual antiplatelet therapy (aspirin + P2Y12 inhibitor), history of percutaneous coronary intervention\n    * Heart rhythm abnormalities\n    * Congestive heart failure of any New York Heart Association class\n    * Symptomatic valvular heart disease (e.g., aortic stenosis)\n    * Pulmonary hypertension\n  * Chronic kidney disease, Stage 3 or higher (estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F 1.73 m2), of any cause\n  * Chronic liver disease other than uncomplicated MASLD, including but not limited to:\n\n    * Advanced liver fibrosis, as determined by non-invasive testing, including fibrosis scores of F3-F4 on VCTE\n    * Cirrhosis of any etiology\n    * Autoimmune hepatitis or other rheumatologic disorder affecting the liver\n    * Biliopathy (e.g., progressive sclerosing cholangitis, primary biliary cholangitis)\n    * Chronic liver infection (e.g., viral hepatitis, parasitic infestation)\n    * Hepatocellular carcinoma\n    * Infiltrative disorders (e.g., sarcoidosis, hemochromatosis, Wilson disease)\n  * Gout\n  * Chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)\n  * Malabsorptive conditions\n  * Active seizure disorder (including controlled with antiepileptic drugs)\n  * Psychiatric diseases that are or have been decompensated within 1 year of screening, and\u002For require use of antipsychotic drugs associated with significant weight gain\u002Fmetabolic dysfunction (e.g., clozapine, olanzapine), monoamine oxidase inhibitors, tricyclic antidepressants, or lithium\n  * Known glucose-6-phosphate dehydrogenase (G6PD) deficiency\n  * Other clinically significant endocrinopathies\n  * Venous thromboembolic disease (deep vein thrombosis or pulmonary embolism) or any required use of therapeutic anticoagulation\n  * Active malignancy, or hormonally active benign neoplasm, except allowances for non-melanoma skin cancer and differentiated thyroid cancer (Stage I only)\n  * Clinical concern for increased risk of volume overload or hypotension (SBP \\\u003C90 and\u002For DBP \\\u003C60 mm Hg), including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n* Clinical concern for increased risk of volume overload or hypotension (SBP \\\u003C90 and\u002For DBP \\\u003C60 mm Hg), including due to medications and\u002For heart\u002Fliver\u002Fkidney problems, as listed above\n* Use of certain medications currently or within 90 d prior to screening:\n\n  * Prescribed medications used for any of the indications in the preceding list of excluded conditions, or their use within 90 d prior to screening, except allowances for:\n\n    * Statins for primary prevention of cardiovascular disease\n    * Use of drugs prescribed for indications other than the exclusionary diagnoses\u002Fpurposes listed above (e.g., non-hydantoin antiepileptic drugs used for non-seizure indications, angiotensin converting enzyme inhibitor\u002Fangiotensin receptor blocker used for uncomplicated hypertension rather than for congestive heart failure, etc.)\n    * Vasodilating drugs for any indication: hydralazine, nitrates, phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil), minoxidil (oral)\n    * Phenytoin or fosphenytoin for any indication\n    * Oral or parenteral corticosteroids (at greater than prednisone 5 mg daily, or equivalent) for more than 3 days within the previous 90 days; topical and inhaled formulations are permitted\n* History of certain weight-loss (bariatric) surgeries, including:\n\n  * Roux-en-Y gastric bypass\n  * Biliopancreatic diversion\n  * Restrictive procedures (lap band, sleeve gastrectomy) performed within past year\n* Clinical concern for alcohol overuse, including based on chart review and\u002For by participant's report of consuming more than 14 standard drinks per week for males or more than 7 standard drinks per week for females\n* Regular use of tobacco, either daily or an average of at least 1 cigarette per day, and\u002For nicotine vaping more than 1 day per week\n* Positive urine drug screen, except for lawfully prescribed medications or marijuana\u002Ftetrahydrocannabinol positivity, provided that the participant agrees not to use it during the same period that they will abstain from alcohol)\n* Atypical circadian rhythm, such as due to night shift work, within 30 days of screening or expected within 30 days of each treatment period\n* History of severe infection or ongoing febrile illness within 14 days of screening\n* Any other disease or condition or laboratory value that, in the opinion of the investigator, would place the participant at an unacceptable risk and\u002For interfere with the analysis of study data.\n* Known allergy\u002Fhypersensitivity to any component of the medicinal product formulations (including sulfa drugs), other biologics, intravenous (IV) infusion equipment, plastics, adhesive or silicone, history of infusion site reactions with IV administration of other medicines, or ongoing clinically important allergy\u002Fhypersensitivity as judged by the investigator.\n* Concurrent enrollment in another clinical study of any investigational drug therapy or use of any biologicals within 5 half-lives of an investigational agent or biologic",{"count":7,"type":21},[89],"The goal of this clinical trial is to compare a one-week course of diazoxide (2 mg\u002Fkg per dose x 14 doses) and placebo in people with obesity and insulin resistance (IR) with metabolic dysfunction-associated steatotic liver disease (MASLD). The main question it aims to answer are how mitigation of compensatory hyperinsulinemia with diazoxide affects hepatic de novo lipogenesis, a major contributor to MASLD pathophysiology.\n\nParticipants will:\n\n* Take 14 doses of placebo over 7 days, followed 4-12 weeks later by either 14 doses of diazoxide (at 2 mg per kg of body weight per dose \\[mpk\\]) or another 14 doses of placebo, over 7 days\n* Take 18 doses of heavy (deuterated) water (50 mL each) over 7 days, twice\n* Have blood drawn and saliva collected after an overnight fast on four mornings over the course of the study\n* Undergo insulin suppression tests (IST) to assess the degree of insulin resistance at the end of each 1-week study period\n* Consume their total calculated daily caloric needs as divided into three meals per day\n\nResearchers will compare blood tests at the beginning and end of each 1-week study period in participants randomized (like the flip of a coin) to receive either placebo followed by diazoxide or placebo followed by placebo, to see how the drug treatment affects de novo lipogenesis, serum insulin, plasma glucose, and other serum lipid parameters (triglycerides, free fatty acids), among others.",[98,29,625,626,65],"Non-Alcoholic Fatty Liver Disease","Prediabetic State",[98,29,628,625,629],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Triglycerides","2026-07-01",{"date":607,"type":41},{"date":630,"type":41},{"date":634,"type":21},"2029-09-30",{"name":108,"class":48},{"id":637,"slug":638,"hasResults":12,"nctId":639,"briefTitle":640,"officialTitle":641,"acronym":642,"eligibilityCriteria":643,"healthyVolunteers":57,"sex":17,"minAge":118,"maxAge":85,"enrollmentInfo":644,"targetDuration":4,"studyType":22,"phases":646,"briefSummary":647,"conditions":648,"keywords":651,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":49},"100642973","food-and-metabolism-study-100642973","NCT07624500","Food and Metabolism Study","Effects of Avocado on Triglyceride Metabolism in Individuals With Insulin Resistance","FAM","Inclusion Criteria:\n\n* Men or women, 40-70 years of age.\n* Fasting triglycerides (TG) \\>115 mg\u002FdL.\n* Insulin resistance as measured by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) \\>2.5.\n* Able to provide informed consent.\n* Able to comply with and perform the procedures requested by the protocol, specifically eat all the meals and snacks provided by the study which will be almost all your food (\\~ 80% of calories per day).\n* Able to come to the clinic up to 6 times during the study.\n* Able to maintain usual physical activity pattern.\n* Able to avoid\u002Fabstain from alcohol and vigorous physical activity for 24 hours prior to and during study visit.\n\nExclusion Criteria:\n\n* Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or interventions.\n* Fasting blood sugar ≥125 mg\u002FdL. Men and women with blood pressure \\>160 mmHg (systolic) \u002F 100 mmHg (diastolic) at the screening visit.\n* Men and women with history of diabetes cardiovascular events, respiratory, renal, gastrointestinal, hepatic or eye disease or surgery- within a year.\n* Men and women who have or had cancer other than non-melanoma skin cancer in the past 5 years.\n* Men and women taking over the counter or prescription medications or dietary supplements that may interfere with study procedures or endpoints.\n* Men and women who are on a specialized diet (vegan, vegetarian, keto, etc.). - - Men and women who consume nuts or peanuts daily or most days of the week.\n* Men and women who are not weight stable (+\u002F-10lbs in previous 2 months). Men and women who have excessive use of drugs or alcohol (ie., addictions) within the past 2 years.\n* Men and women with documented physical or mental disease\u002Fcondition, which might limit participation in or completion of the study or, that, in the opinion of the investigator, could interfere with the interpretation of the study results.\n* Women who are known to be pregnant or who are intending to become pregnant over the course of the study.\n* Women who are lactating.\n* Major trauma or a surgical event within 2 months (or longer depending on trauma or event) and after consultation with PI. Has used antibiotics within the previous 2 months.\n* History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.\n* Excessive coffee and tea consumers (\\> 4 cups\u002Fd).\n* Donated blood within the last 3 months.\n* Women who are taking an unstable dose and brand of hormonal contraceptives and\u002For a stable dose and brand for less than 6 months.\n* Unusual working hours (working overnight).",{"count":645,"type":21},82,[24],"In this study, Investigators are interested in looking at the influence of eating avocados regularly, which are rich in healthy fats, fibers, and unique carbohydrates, on triglyceride and glucose metabolism in people with prediabetes and insulin resistance.",[649,29,629,650],"Prediabetes","Lipids Metabolism",[629,96,652,653],"Glucose metabolism","Lipids metabolism","2026-06-29",{"date":630,"type":41},{"date":657,"type":41},"2026-06-03",{"date":659,"type":21},"2027-12-31",{"name":661,"class":662},"Clinical Nutrition Research Center, Illinois Institute of Technology","INDUSTRY",{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":669,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":671,"targetDuration":4,"studyType":22,"phases":672,"briefSummary":673,"conditions":674,"keywords":676,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":678,"startDateStruct":680,"completionDateStruct":681,"leadSponsor":683,"locationsCount":297},"100639897","prediabetes-glycemic-impact-and-data-evaluation-100639897","NCT07599072","PREdiabetes GLycemic Impact and Data Evaluation","Evaluation of the Impact of Continuous Glucose Monitoring (CGM) Systems on Glycemic Control in People With Prediabetes: Postmarketing Clinical Study","PRE-GLIDE","Inclusion Criteria:\n\n* Age of 18 years and older.\n* Presence of prediabetes diagnosed according to criteria of the American Diabetes Association\n* Persons who treated with diet and exercise alone or metformin on a stabilized dose for at least 3 months before the study;\n* Ability to comply with protocol requirements and maintain a patient diary.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Presence of type 1 or type 2 diabetes;\n* Decompensated liver or kidney diseases (GFR \\\u003C 45 ml\u002Fmin\u002F1. 73 m²);\n* Active cardiovascular diseases within 12 months of Visit 1, such as myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study;\n* Endocrine disorders (e.g., Itsenko-Cushing syndrome, acromegaly) that affect glycemia;\n* Pregnancy or lactation;\n* Mental or cognitive impairments that would interfere with study participation;\n* Daily use of any form of steroid medication (oral, inhaled, injected) within the last 3 months;\n* Recent use of any CGM within the last 12 months;\n* Known allergy to sensor materials;\n* Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant;\n* Participation in another clinical study within the last 3 months.",{"count":306,"type":21},[24],"This prospective, randomized controlled trial evaluates whether real-time continuous glucose monitoring (CGM) improves glycemic control and lifestyle adherence in adults with prediabetes compared to conventional self-monitoring methods over a 3-month period. By analyzing metabolic markers and behavioral data, the study aims to determine the effectiveness of 24-hour monitoring as a personalized tool that increases patient adherence to lifestyle changes compared to conventional SMBG methods.",[675,93,29],"Pre Diabetic",[677,553,554,34,555],"prediabetes",{"date":679,"type":41},"2026-06-30",{"date":630,"type":21},{"date":682,"type":21},"2027-06-30",{"name":562,"class":48},{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":689,"acronym":690,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":17,"minAge":117,"maxAge":177,"enrollmentInfo":692,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":694,"conditions":695,"keywords":700,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":704,"lastUpdatePostDateStruct":705,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":710,"locationsCount":49},"100645093","the-muscle-monitor-early-skeletal-muscle-indicators-of-insulin-resistance-and-cardiometabolic-risk-100645093","NCT07678736","The Muscle Monitor: Early Skeletal Muscle Indicators of Insulin Resistance and Cardiometabolic Risk","The Muscle Phenotype and Cardiometabolic Health Monitoring Project","MUSCLE MONITOR","Inclusion Criteria:\n\n* Sex: Males and females\n* Age: 20-30 years\n* BMI \\\u003C35\n* Healthy (no diagnosed chronic disease)\n\nExclusion Criteria:\n\n* Chronic disease deemed to affect study outcomes\n* Disease that increase haemorrhage risk\n* Daily intake of medication that could confound study outcomes\n* Regular smokers\n* Active pregnancy\n* Immobilization (inactivity due to injury or illness, e.g. cast or brace) for more than a week in the month prior to the study or for more than 4 weeks in the past 6 months prior to the study\n* Very high structured physical exercise level (\\>10 h\u002Fweek).\n* Participants not willing to adhere to standardized meal prescriptions included in the study protocols will also be excluded (due to e.g. allergies or specific dietary preferences)",{"count":693,"type":21},250,"Insulin resistance is an early etiological factor in the development of type-2 diabetes (T2D), which constitutes a large societal health burden with an expected additional rise in the years to come.\n\nSkeletal muscle is the body's largest lean tissue mass and the major site of glucose disposal in response to insulin stimulation. Prior studies have suggested that a fast skeletal muscle phenotype, including a predominant fast muscle fiber composition, reduced capillary density, low fat oxidation and muscle oxidative capacity may be implicated in insulin resistance and TD2 development. However, key questions pertain in relation to the cause and effect of these relationships as well as the interaction with potential confounders and effect-modifiers including life-style factors (e.g. diet and physical activity levels) and general participant characteristics (e.g. body composition and training status).\n\nIn the present project, we therefore aim to derive muscle fiber type and extensively map the proteomic signature of the early stages of insulin resistance in a large cross-sectional study using a young and apparently healthy cohort prior to T2D development, including a thorough participant characterization. We will recruit \\~250 participants (men and women) in the age of 20-30 years and conduct extensive phenotyping and tissue sampling across one laboratory-based test day and a scan visit, as well as measurements of physical activity level and glucose handling in free-living conditions with wearable sensors.\n\nThe study has a longitudinal aspect as participants will be re-invited at 5-year intervals for up to 20 years to delineate the trajectory of metabolic health in relation to muscle phenotype measures.\n\nThe results of the project are expected to lead to significant advancements in our understanding of the importance of muscle phenotype for early-stage insulin resistance and metabolic health trajectories. Such understanding has potentially important clinical implications, as it can open new avenues for targeted interventions and individualized early preventive strategies to counter or delay the progression of insulin resistance and associated metabolic and cardiovascular disorders.",[29,696,697,698,699],"Insulin Resistance and Type 2 Diabetes","Cardiometabolic Risk Factors","Physical Activity","Muscle Fiber Type",[701,702,703],"Insulin sensitivity","Skeletal muscle","Physical activity","2026-06-24",{"date":630,"type":41},{"date":707,"type":41},"2025-05-19",{"date":709,"type":21},"2046-12-31",{"name":711,"class":48},"University Ghent"]