[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prediabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prediabetes":61},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,131,0,25,[9,45,80,107,133,160,187,226,251,276,303,347,378,401,429,461,494,514,535,559,580,608,634,669,695],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100524721","a-randomized-comparison-of-stage-based-care-versus-risk-factor-based-care-for-prevention-of-cardiovascular-events-100524721",false,"NCT06112418","A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events","A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events","TRANSFORM","Inclusion Criteria:\n\n1. Provided electronic or written informed consent\n2. Men \\> 55, women \\> 65 years of age\n3. Type 2 diabetes mellitus requiring pharmacologic therapy, prediabetes (most recent HbA1c 5.7 to 6.4% and\u002For fasting glucose 100-125 mg\u002FdL \\[5.6-6.9 mmol\u002FL\\]) and\u002For metabolic syndrome. Metabolic syndrome is defined as \\> 3 of the following criteria (International Diabetes Federation 2006):\n\n   * Body mass index ≥ 27 kg\u002Fm2 or abnormal waist circumference defined as ≥ 80 cm (31.5 inches) for women, ≥ 94 cm (37 inches) for men; for South and East Asian men (e.g., Asian Indian, Chinese, Japanese) ≥ 90 cm (35.4 inches)\n   * Fasting triglycerides ≥ 150 mg\u002FdL (1.7 mmol\u002FL) or treated hypertriglyceridemia\n   * HDL-cholesterol (HDL-C) \\\u003C 40 mg\u002FdL (1.03 mmol\u002FL) in men, \\\u003C50 mg\u002FdL (1.29 mmol\u002FL) in women or treatment for this lipid abnormality\n   * Systolic blood pressure (BP) ≥ 130 and\u002For diastolic BP≥ 85 mm Hg and\u002For treated hypertension\n   * Fasting blood glucose ≥ 100 mg\u002FdL (5.6 mmol\u002FL) or HbA1c ≥ 5.7%\n4. Have a device (e.g., smartphone, tablet, computer) for communication with the central cardiologist-led team managing drug treatment for the personalized care group\n\nExclusion Criteria:\n\n1. History of symptomatic CVD defined as prior MI, exertional or unstable angina, ischemic stroke, claudication, arterial revascularization for atherosclerosis or other CVD being actively managed by a cardiologist, e.g. atrial fibrillation, heart failure\n2. Planned arterial revascularization\n3. Inability to complete screening CCTA or any condition that would increase the risk associated with CCTA or increase likelihood of uninterpretable scan including:\n\n   1. eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation (www.kidney.org\u002Fprofessionals\u002Fkdoqi\u002Fgfr\\_calculator)\n   2. Allergy to iodinated contrast or history of contrast-induced nephropathy (including adverse reaction to contrast at screening CCTA) or screening laboratory values consistent with untreated hyperthyroidism. Participants with elevated thyroid-stimulating hormone (TSH) may be enrolled but should be referred to their physician for evaluation for treatment.\n   3. Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment\n   4. Weight \\> 300 lbs. (136 kg) or above manufacturer-recommended limit for scanner and table at the site\n   5. Inability to hold breath for \\> 10 seconds\n   6. Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \\> 80 beats per minute at screening or prior to CCTA)\n   7. Contraindication to dosing with beta blocker or nitroglycerin on day of screening CCTA\n   8. Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA\n4. Unsuitable as a trial participant in the opinion of the investigator for reasons including significant left main stenosis (e.g. ≥ 70%; site will be notified by Cleerly), other health condition with life expectancy \\\u003C 3 years or being at risk of poor compliance with study procedures (e.g., active substance abuse or untreated mental illness that, in the opinion of the investigator, is likely to adversely affect adherence or retention)",true,"ALL","55 Years",{"count":22,"type":23},7500,"ESTIMATED","INTERVENTIONAL",[26],"NA","TRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.",[29,30,31],"Diabetes Mellitus, Type 2","PreDiabetes","Metabolic Syndrome","RECRUITING","2026-08-18",{"date":35,"type":36},"2026-08-19","ACTUAL",{"date":38,"type":36},"2024-03-06",{"date":40,"type":23},"2029-03-05",{"name":42,"class":43},"Cleerly, Inc.","INDUSTRY",125,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":19,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100627464","phase-3-vitamin-d-and-type-2-diabetes---treat-to-target-100627464","NCT07448974","Vitamin D and Type 2 Diabetes - Treat-To-Target","Vitamin D and Type 2 Diabetes, Treat-To-Target","D2d-TTT","Inclusion Criteria:\n\n1. High-risk prediabetes (\"at high risk for type 2 diabetes\") defined by meeting the following 2 prediabetes criteria established by the American Diabetes Association (ADA) in the 2010 clinical practice guidelines:\n\n   1. Fasting plasma glucose (FPG) 100-125 mg\u002FdL, inclusive\n   2. Hemoglobin A1c (HbA1c) 5.7-6.4%, inclusive\n2. Age 30-74 years, inclusive\n3. Body Mass Index ≥ 23.0 and ≤ 35.0 kg\u002Fm2\n4. Provision of signed and dated written informed consent prior to any study procedures.\n\n   Exclusion Criteria:\n5. History of diabetes (ICD10 diabetes code E08.X through E13.X) or meeting a diabetes glycemic criterion at screening, as defined by the ADA guidelines (FPG ≥ 126 mg\u002FdL or HbA1c ≥ 6.5%).\n6. History (past 2 years) of hyperparathyroidism, symptomatic or asymptomatic (i.e., radiographic) nephrolithiasis or hypercalcemia.\n7. Any medical condition (past 2 years) that in the opinion of the site investigator may increase risk for nephrolithiasis or hypercalcemia during the trial (e.g., sarcoidosis).\n8. If older than 70 years, history (past 1 year) of a fall.\n9. Use of tanning devices within 12 weeks of the baseline visit and unwilling to stop use of tanning devices for the duration of the study.\n\n   Medications and Supplements\n10. Use (past 6 months) of hypoglycemic pharmacotherapy (oral or injectable medication approved by the FDA for type 2 diabetes) for any condition (e.g., prediabetes, diabetes, polycystic ovarian syndrome, MASLD, sleep apnea) or any other medication that may affect glycemia (e.g., hydroxychloroquine)\n11. Current use of medications approved by the FDA for weight management (e.g., incretin receptor agonists) or planned use during the study.\n12. Use of supplements containing vitamin D at total doses higher than 1000 IU\u002Fday within 8 weeks of the baseline visit and unwillingness to limit vitamin D supplementation dosage to no higher than 1000 IU\u002Fday during the study. Because supplements vary widely in vitamin D content (e.g., may include cod liver or cod liver oi), participants will bring all supplements to the site for a review by the research team.\n13. Use of supplements containing calcium at total doses higher than 600 mg\u002Fday within 1 week of the baseline visit and unwillingness to limit calcium supplementation dosage to no higher than 600 mg\u002Fday during the study.\n14. Current use of medications or conditions (e.g., untreated celiac disease) that would interfere with the absorption or metabolism of vitamin D.\n15. Use of an anticonvulsant drug started within 6 months of screening. Stable regimen of anticonvulsants is allowed.\n16. History of intolerance to vitamin D supplements, allergic to any content of the study drug or unwilling to take vitamin D supplements (e.g., someone who eats a vegan diet and would object to the cholecalciferol ingredient which is produced from cholesterol extracted from sheep wool harvested from healthy living sheep).\n\n    Other Medical History\n17. Severe symptomatic cardiovascular disease based on history (unstable angina, dyspnea on exertion, paroxysmal nocturnal dyspnea, arrhythmia, congestive heart failure NYHA class II or higher, claudication)\n18. History (past 1 year) of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass graft.\n19. History (past 1 year) of cerebrovascular disease (stroke, transient ischemic attack).\n20. Any type of cancer (past 5 years) except for basal cell skin cancer. Prostate cancer (for men over age 55) or well-differentiated thyroid cancer not expected to require treatment (except for suppression with thyroid hormone) over the next 3 years, are not exclusions. People with history of squamous cell cancer of the skin, which was completely excised and with no evidence of metastases, are eligible.\n21. History (past 6 months) of treatment with oral (for \\> 7 days) or intravenous glucocorticoids or disease likely to require oral or intravenous glucocorticoid therapy during the study. Inhaled glucocorticoid use is not an exclusion. Epidural or intra-articular glucocorticoid injections are not exclusions, but study visits need to be conducted at least two weeks after the injection. Persons with adrenal insufficiency treated with physiologic doses of glucocorticoids who are otherwise stable are not excluded.\n22. History (past 1 year) of substance abuse or unstable psychiatric disorder that in the opinion of the site investigator would impede competence or adherence with study procedures or hinder completion of the study or increase risk.\n23. History of bariatric surgery (e.g., Roux-en-Y gastric bypass, gastric sleeve) or planned bariatric surgery in the next 2 years.\n24. Extreme (over 18 hours) intermittent fasting diets because prolonged fasting downregulates CYP2R1 activity.\n25. A life-threatening event within 30 days of screening or currently planned major surgery.\n26. Any other active medical condition (including but not limited to liver disease, wasting illness, HIV, tuberculosis, oxygen-dependent chronic obstructive pulmonary disease, organ transplant, Cushing's syndrome) that in the opinion of the site investigators would interfere with the study objectives, impede competence or adherence with study procedures or increase risk.\n27. Uncontrolled hypertension (systolic blood pressure \\> 160 mm Hg or diastolic blood pressure \\> 100 mm Hg).\n28. Poor venous access.\n\n    Laboratory Evaluation\n29. Serum liver transaminase higher than 3 times the normal range for the clinical site's laboratory, within 18 months of screening.\n30. Anemia (hematocrit \\\u003C 32 for women, \\\u003C 36 for men), whole blood transfusion (within 18 months of screening) or chronic requirement, whole blood donation (within 3 months of screening) or other condition (hemolysis, hemoglobinopathy) rendering HbA1c results unreliable as indicator of chronic glycemia. Participants who donate platelets are not excluded.\n31. Low platelet count (\\\u003C 100,000) within 18 months of screening.\n32. Chronic kidney disease, defined as estimated glomerular filtration rate \\[GFR\\] \\\u003C 50 mL\u002Fmin per 1.73 m2 from creatinine level and GFR calculated by the new Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations that omit race within 18 months of screening.\n33. Hypercalcemia, defined as serum calcium concentration ≥ upper limit of normal within 18 months of screening.\n34. Hypercalciuria, defined as spot urine (morning void) calcium-creatinine ratio \\> 0.275 within 18 months of screening.\n35. Baseline serum 25(OH)D level greater than 100 ng\u002FmL.\n\n    Other\n36. Participation (within 30 days of screening) in another interventional research study, and unwillingness to refrain from participating in another intervention study during the study.\n37. Previous randomization in the study. Participants who did not qualify after screening may be screened again if the prior reason for exclusion has been addressed (e.g., high blood pressure is treated).\n38. Any other reason that in the opinion of the site investigator would interfere with the study objectives, impede adherence with study procedures or hinder completion of the study or increase risk.\n\n    Women only\n39. Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to become pregnant in the next 2 years. History of gestational diabetes is not an exclusion criterion.\n40. Currently breastfeeding.\n41. Use of oral contraceptives or menopausal hormone therapy started within 3 months of baseline. .\n\n    Continuous Glucose Monitoring specific\n42. Regular use of personal CGM and unwillingness to refrain from using personal CGM for the duration of the study.\n43. Use of hydroxyurea or regular use of high doses of acetaminophen (may impact CGM).\n44. Extensive skin changes (e.g., skin breakdown, rash) making CGM sensor use problematic.\n45. Significant skin sensitivity to adhesive (making CGM sensor unfeasible).","30 Years","74 Years",{"count":56,"type":23},100,[58],"PHASE3","This study tests whether taking a weekly dose of vitamin D, with the dose adjusted to reach a target blood vitamin D level, can help control blood sugar levels in adults at high risk of developing type 2 diabetes (prediabetes).\n\nResearch suggests that vitamin D may play a role in blood sugar control. The goal of this study is to see whether adjusting the dose of vitamin D to reach a specific blood vitamin D level improves blood sugar control compared with a placebo (a look-alike pill without vitamin D).\n\nOne hundred adults aged 30 to 74 with prediabetes will take part. Participants will be randomly assigned (by chance) to receive either weekly vitamin D supplements or a placebo. Neither the participants nor the research team will know which group a participant is in during the study.\n\nParticipants in the vitamin D group will start with one specific dose. After three months, a blood test will be used to decide whether the dose should stay the same or be increased to reach the target vitamin D level. Participants in the placebo group will continue taking the placebo each week.\n\nAll participants will be followed for about 18 months. During the study, they will attend scheduled study visits, have blood tests, and wear a continuous glucose monitor, a small device that measures blood sugar levels throughout the day and night. The research team will also make periodic phone calls to check on health changes, medication use, and study participation.\n\nThe main outcome of the study is the proportion of time that the participants' blood sugar levels remains in a healthy range.",[61,62],"Prediabetes","Type 2 Diabetes (T2DM)",[64,65,66,67,68,69],"vitamin D","cholecalciferol","continuous glucose monitoring","diabetes prevention","prediabetes","type 2 diabetes","2026-08-14",{"date":33,"type":36},{"date":73,"type":36},"2026-08-04",{"date":75,"type":23},"2031-03",{"name":77,"class":78},"Tufts Medical Center","OTHER",1,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":24,"phases":91,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":79},"100651690","effect-of-csir-developed-high-protein-low-glycaemic-index-rice-on-glycaemic-response-in-individuals-with-prediabetes-100651690","NCT07762768","Effect of CSIR-Developed High-Protein, Low-Glycaemic Index Rice on Glycaemic Response in Individuals With Prediabetes","Effect of CSIR-Developed High-Protein, Low-Glycaemic Index Rice on Glycaemic Response in Individuals With Prediabetes: An Acute and Subacute Crossover Study","Inclusion Criteria:\n\n* Age 18-60 years\n* Individuals with prediabetes, defined by oral glucose tolerance test (OGTT) as:\n\n  * Fasting plasma glucose ≥100 mg\u002FdL and \\\u003C126 mg\u002FdL, and\u002For\n  * 2-hour plasma glucose ≥140 mg\u002FdL and \\\u003C200 mg\u002FdL following ingestion of 75 g anhydrous glucose\n* Willingness to participate and comply with study procedures\n\nExclusion Criteria:\n\n* Diagnosed diabetes mellitus\n* Acute infections or any debilitating illness\n* History of hepatic, pancreatic, renal, or cardiovascular disease\n* Abnormal liver or renal function tests\n* Recent (\\\u003C3 months) weight change ≥5% or use of weight-altering medications\n* Use of glucose-lowering medications\n* Pregnancy or lactation\n* Known allergy or intolerance to study foods\n* Any condition that, in the investigator's opinion, may interfere with study participation","18 Years","60 Years",{"count":90,"type":23},36,[26],"This is a randomized, controlled, two-phase crossover study will be conducted in adults aged 18-60 years with prediabetes to compare the effects of a CSIR-developed high-protein, low-glycaemic index rice with conventional rice. Phase I will evaluate acute postprandial glucose, insulin, C-peptide, GLP-1, and hunger\u002Fsatiety responses, while Phase II will assess 72-hour continuous glucose monitoring (CGM) outcomes, including mean glucose and glycaemic variability. Eligible participants will be randomly assigned to receive both rice types in a crossover manner, with each participant serving as their own control. Individuals with diabetes, major systemic illnesses, abnormal liver or renal function, pregnancy, or glucose-lowering medication use will be excluded.",[61],[95,96,61],"High-Protein, Low-Glycaemic Index Rice","Conventional Rice","NOT_YET_RECRUITING","2026-08-11",{"date":100,"type":36},"2026-08-13",{"date":102,"type":23},"2026-09-01",{"date":104,"type":23},"2027-02-28",{"name":106,"class":78},"Diabetes Foundation, India",{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":18,"sex":19,"minAge":53,"maxAge":20,"enrollmentInfo":115,"targetDuration":4,"studyType":24,"phases":117,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":79},"100601127","training-induced-muscle-adipose-ev-communication-100601127","NCT07106450","Training Induced Muscle-Adipose EV Communication","Muscle-derived Extracellular Vesicles and Their Interactions With Adipocytes in Human Metabolic Dysfunction","TIMER2","Inclusion Criteria:\n\n* Age 30-55 years\n* Sedentary lifestyle (exercise \\\u003C1 day\u002Fweek for at least 3 months prior to enrollment)\n* Able to provide informed consent\n* For Control Group: BMI \\\u003C 27 kg\u002Fm², normal glucose tolerance, no more than 1 feature of metabolic syndrome\n* For Prediabetic Group: BMI \\> 30 kg\u002Fm², at least 3 features of metabolic syndrome including prediabetes (defined as fasting plasma glucose 100-125 mg\u002FdL OR 2-hour post-load glucose on 75g OGTT 140-199 mg\u002FdL OR HbA1C 5.7-6.4%)\n\nExclusion Criteria:\n\n* Pregnancy (confirmed by pregnancy test in women of childbearing potential)\n* Type 2 diabetes mellitus\n* Cardiovascular contraindications to resistance exercise\n* Medical conditions that would interfere with muscle or adipose tissue biopsy procedures\n* Use of medications that significantly affect glucose metabolism or exercise response\n* Active participation in structured exercise programs (\\>1 day\u002Fweek) within 3 months of enrollment\n* Inability to safely participate in resistance exercise protocol",{"count":116,"type":23},40,[26],"This study examines how muscle cells communicate with fat cells through tiny packages called extracellular vesicles (EV) during exercise. These vesicles carry important molecules that may affect how the body processes sugar and fat. The research team observed significant variability in the adipose response to exercise, and used this variability to gain further insight into the mechanism through which mature microRNA-1 (miR-1) changes in adipose tissue. The investigators selected six subjects with the highest increase in miR-1 abundance in adipose tissue after exercise and compared them with the six subjects that had the most dramatic decrease in miR-1 abundance after exercise. The research team observed that participants intrinsically vary in their ability to endocytose EV into adipose tissue. It is unclear whether this variance in receptivity is a cause or consequence of the significant difference in EV-delivery of miR-1 to adipose tissue.",[61],[121,122,123],"muscle","extracellular vesicles","adipose","2026-08-07",{"date":126,"type":36},"2026-08-10",{"date":128,"type":23},"2026-09",{"date":130,"type":23},"2028-09-30",{"name":132,"class":78},"Yuan Wen",{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100633644","pharmacist-led-continuous-glucose-monitoring-for-prediabetes-100633644","NCT07529366","Pharmacist-Led Continuous Glucose Monitoring for Prediabetes","Redefining Prediabetes Care: Pharmacist-Led Continuous Glucose Monitoring to Drive Lifestyle Change","Inclusion Criteria:\n\n* adults 18-70 years of age\n* prediabetes (HbA1c 5.7-6.4%)\n* compatible smartphone with the Dexcom Stelo sensor system\n* have not have worn a CGM in the last 6 months prior to enrollment\n\nExclusion Criteria:\n\n* any of the following forms of diabetes: type 1 diabetes, type 2 diabetes, monogenic diabetes, cystic fibrosis-related diabetes, post- transplant diabetes, latent autoimmune diabetes\n* problematic hypoglycemia in the prior 6 months \\[defined as recurrent (more than one) level 2 hypoglycemic events (glucose \\\u003C54mg\u002FdL ) that persist despite multiple attempts to adjust medication(s) and\u002For modify the diabetes\u002Ftreatment plan or a history of one level 3 hypoglycemic event (glucose \\\u003C54mg\u002FdL) characterized by altered mental and\u002For physical state requiring third-party assistance for treatment of hypoglycemia\\]\n* pregnant, or planning to become pregnant during the study time frame\n* currently receiving or planned to receive dialysis during the study time frame - current use of systemic steroids for any condition\n* a known allergy to medical grade adhesives,\n* use of any CGM device in the past 6 months\n* history of a diagnosed eating disorder\n* current use of a second-generation antipsychotic at the time of consent (aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)\n* subjects lacking capacity to provide informed consent","70 Years",{"count":116,"type":23},"OBSERVATIONAL","The goal of this observational study is to determine if a pharmacist-led program involving continuous glucose monitoring (CGM) improves glucose control and health behavior in people with prediabetes. The main questions it aims to answer are:\n\n1. Determine impact of pharmacist-led CGM on glycemic control in people with prediabetes. Researchers will compare change in hemoglobin A1c at 12 weeks with pharmacist-led CGM versus a historical cohort of subjects with prediabetes receiving no CGM. The investigators will also assess change in CGM-derived glycemic metrics from baseline to end of the CGM wear period in the intervention group.\n2. Evaluate impact of pharmacist-led CGM on health behavior change in people with prediabetes in the intervention group. Participants will be asked to complete the Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF-36) at baseline, at the end of week 4, and at the end of the study so that researchers can measure the effects in the intervention group on health behavior change.",[61],[68,66,146,147,148,149,150,151],"pharmacist","health behavior","Hemoglobin A1c","endocrinology","primary care","CGM","2026-08-05",{"date":126,"type":36},{"date":102,"type":23},{"date":156,"type":23},"2027-07-31",{"name":158,"class":78},"University of South Florida",2,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":167,"minAge":168,"maxAge":20,"enrollmentInfo":169,"targetDuration":4,"studyType":24,"phases":171,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":79},"100618074","effects-of-a-mediterranean-diet-with-cycling-and-rowing-exercise-on-blood-sugar-in-women-with-prediabetes-100618074","NCT07326891","Effects of a Mediterranean Diet With Cycling and Rowing Exercise on Blood Sugar in Women With Prediabetes","Continuous Glucose Monitoring in Prediabetics on a Mediterranean Diet With Sequentially Added Cycling and Rowing Training: Study Protocol for a Prospective Non-Randomized Study","Inclusion Criteria:\n\n* Having a diagnosis of prediabetes (within the last 1 year)\n\n  * Impaired Fasting Glucose (IFG) 100-125 mg\u002Fdl\n  * OGTT result 2-hour postprandial Impaired Glucose Tolerance (IGT) 140-199 mg\u002Fdl\n  * HbA1c 5.7-6.4%\n* Being between 22-55 years of age\n* Being female\n* Body Mass Index 18-34.9 kg\u002Fm2\n* Meeting the criteria in the American College of Sports Medicine (ACSM) and American Heart Association (AHA) cardiovascular disease risk assessment scoring system\n* Not engaging in regular planned exercise or physical activity (sedentary)\n\nExclusion Criteria:\n\n* Diabetes\n* Being pregnant\n* No self-reported low iron concentrations or anaemia\n* Use of medication, insulin, or weight loss injections known to affect lipid and glucose metabolism\n* Presence of cardiovascular disease\n* Current smoking or excessive alcohol consumption\n* Presence of abnormal electrocardiogram (ECG)\n* Presence of autonomic neuropathy\n* Presence of uncontrolled hypertension (systolic blood pressure \\>135 mmHg, diastolic blood pressure \\>85 mmHg)\n* Joint-muscle-bone injury limiting exercise","FEMALE","22 Years",{"count":170,"type":23},30,[26],"The goal of this clinical trial is to learn how a Mediterranean-style diet, with and without added exercise, affects blood sugar control in women with prediabetes. Prediabetes means blood sugar levels are higher than normal but not yet type 2 diabetes. Healthy eating and regular physical activity can help prevent diabetes.\n\nThe investigators aim to answer two main questions:\n\n1. Does adding a supervised program of cycling and rowing exercises to the diet lead to better blood sugar control than the diet alone?\n2. Do women who recently returned to normal blood sugar levels respond differently to the exercise program than those who currently have high blood sugar?\n\nParticipants will be placed into one of three groups based on current blood sugar levels and medical fitness for exercise:\n\n* Group 1 (Diet only): Will follow a Mediterranean eating plan for 12 weeks.\n* Group 2 (Diet + Exercise, Current High Blood Sugar): Will follow the same diet and also do supervised exercise (cycling, then rowing) three times a week for 8 weeks.\n* Group 3 (Diet + Exercise, Recent Normal Blood Sugar): Will follow the same diet and exercise program as Group 2. These women had prediabetes in the past year but now have normal blood sugar levels.\n\nAll participants will follow the study protocol for 12 weeks, which includes the following key components:\n\n* Dietary Intervention: Adherence to a Mediterranean-style eating plan, which emphasizes high intake of vegetables, fruits, whole grains, legumes, olive oil, and fish.\n* Continuous Glucose Monitoring: Wearing a continuous glucose monitoring (CGM) device-a small, minimally invasive sensor placed on the upper arm-during multiple 10-day periods. This device tracks interstitial glucose levels throughout the day and night to assess daily glucose patterns.\n* Blood Sampling and Analysis: Providing fasting blood samples for the measurement of glycemic and metabolic health markers. These include fasting plasma glucose, hemoglobin A1c (HbA1c), fasting insulin, and 2-hour oral glucose tolerance test (OGTT) results.\n* Anthropometric Assessments: Undergoing standardized measurements of height, body weight, body fat percentage (via bioelectrical impedance), waist circumference, and Body Mass Index (BMI) at scheduled intervals.\n* Questionnaires: Completing validated surveys to assess habitual dietary intake, sleep quality and duration, and levels of physical activity.\n\nInvestigators will compare changes in blood sugar control and other health measures from the start to the end of the 12-week study among the three groups.",[61],[61,175,176,177,178],"Continuous Glucose Monitoring","Mediterranean Diet","Glycaemic Variability","Aerobic Exercise",{"date":180,"type":36},"2026-08-06",{"date":182,"type":36},"2025-12-15",{"date":184,"type":23},"2026-12",{"name":186,"class":78},"Begüm Yücesoy Güneysu",{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":19,"minAge":194,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":24,"phases":198,"briefSummary":199,"conditions":200,"keywords":208,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":222,"leadSponsor":224,"locationsCount":79},"100650884","long-term-effects-of-avocado-consumption-on-health-in-pre-diabetic-individuals-100650884","NCT07752225","Long-term Effects of Avocado Consumption on Health in Pre-diabetic Individuals","Effects of Long-term Avocado Consumption on Brain and Peripheral Cardiovascular Health in Pre-diabetic Individuals","Inclusion Criteria:\n\n* Men and women, aged between 40-75 years\n* Pre-diabetes: (A1C of 5.7%-6.4%, a fasting plasma glucose (FPG) of 100-125 mg\u002FdL, or a 2-hour oral glucose tolerance test (OGTT) result of 140-199 mg\u002FdL)\n* BMI ³ 25 kg\u002Fm2\n* Fasting serum total cholesterol \\\u003C 8.0 mmol\u002FL\n* Systolic blood pressure \\\u003C 160 mmHg and diastolic blood pressure \\\u003C 100 mmHg\n* Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study\n\nExclusion Criteria:\n\n* Age less than 40 years old or older than 75 years\n* BMI \\\u003C 25 kg\u002Fm2\n* Type 1 or type 2 diabetes\n* habitual consumption of more than 1 avocado\u002F week\n* Left-handedness\n* Fasting serum total cholesterol \\> 8.0 mmol\u002FL\n* Current smoker, or smoking cessation \\\u003C 12 months\n* Abuse of drugs\n* More than 3 alcoholic consumptions per day\n* Use medication to treat blood pressure, lipid or glucose metabolism\n* Use of an investigational product within another biomedical intervention trial within the previous 1-month\n* Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis\n* Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident\n* Contra-indications for MRI imaging (e.g. pacemaker, surgical clips\u002Fmaterial in body, metal splinter in eye, claustrophobia)\n* Blood donation in the 8 weeks before the start of the study\n* Difficulties to draw blood","40 Years","75 Years",{"count":197,"type":23},34,[26],"Primary aim of the study is to assess the effect of 12-week daily avocado consumption on cerebral blood flow and markers of cardio- and vascular health in both, the periphery and the brain, in pre-diabetic individuals with overweight or obesity. Secondary objective is to assess the effects of 12-week daily avocado consumption on brain insulin sensitivity after intranasal insulin delivery, vascular function, markers of metabolic health, cognition, and psychological well-being. For that purpose a total of 34 men and women between the ages of 40-75 years old, will participate in a randomised crossover intervention study.",[61,201,202,203,204,205,206,207],"Brain Insulin Sensitivity","Cerebral Blood Flow","Satiety and Food Intake","Food Reward","Brain Health","Vascular Function","Obesity & Overweight",[209,210,211,202,212,213,214,215,216,217,218],"Avocados","Brain insulin sensitivity","Brain vascular function","CBF","pCASL MRI","CANTAB","Overweight","Obesity","cognitive performance","brain health","2026-08-03",{"date":124,"type":36},{"date":102,"type":23},{"date":223,"type":23},"2028-08-31",{"name":225,"class":78},"Maastricht University Medical Center",{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":233,"enrollmentInfo":234,"targetDuration":4,"studyType":24,"phases":236,"briefSummary":237,"conditions":238,"keywords":239,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":159},"100572955","effects-of-autonomic-nervous-system-modulation-by-heart-rate-variability-biofeedback-training-with-resonant-frequency-breathing-on-glucose-metabolism-in-individuals-with-prediabetes-100572955","NCT06739993","Effects of Autonomic Nervous System Modulation by Heart Rate Variability Biofeedback Training With Resonant Frequency Breathing on Glucose Metabolism in Individuals With Prediabetes","RwHRVBFinPD","Inclusion Criteria:\n\n* Presence of prediabetes Fasting glucose: 100-125 mg\u002Fdl (5.6-6.9 mmol\u002FL) and\u002For HbA1c in %: 5.7-6.4 (39-47 mmol\u002Fmol Hb) and\u002For 2-hour value of the 75 g OGTT: 140-199 mg\u002Fdl (7.8-11.0 mmol\u002FL)\n\n  * This is checked using a 75 g OGTT in a screening visit.\n* Age between 18 and 65 years\n* BMI between 20 and 40 kg\u002Fm²\n\nExclusion Criteria:\n\n* Diabetes mellitus\n* Malignant diseases within the last 5 years before randomization\n* History of gastrointestinal surgery\n* Pancreatic diseases other than pancreatic lipomatosis\n* Acute diseases or infections\n* Regular intake of cardiac drugs that affect heart rate within the last 4 weeks before the first measurement (e.g. beta-receptor blockers, antiarrhythmics, etc.)\n* Intake of centrally acting drugs\n* Medical contraindications to a meaningful interpretation of the heart rate analysis (e.g. patients with pacemakers, atrial fibrillation or other arrhythmias)\n* Chronic diseases (particularly metabolic diseases, heart diseases, blood diseases)\n* Endocrinological disease other than substituted hypothyroidism\n* Mental illnesses\n* Intake of drugs that can affect blood sugar metabolism (e.g. steroids)","65 Years",{"count":235,"type":23},60,[26],"Approximately 20% of adults have prediabetes in Germany. Prediabetes is defined as a condition with glucose levels outside the normal range but not yet meeting the criteria for type 2 diabetes. The pathogenesis of prediabetes, as well as of type 2 diabetes, involves whole-body insulin resistance associated with inadequate insulin secretion. These two central processes of glucose regulation are modulated by the brain. The brain communicates via the autonomic nervous system (ANS) with metabolically important organs in the periphery to modulate insulin sensitivity and insulin secretion. These processes are impaired in individuals with prediabetes and diabetes. An ANS sympathovagal imbalance has also been observed in individuals with prediabetes. There are no specific therapeutic approaches to improve ANS sympathovagal imbalance. It is assumed that resonant frequency breathing (RFB) maximizes heart rate variability (HRV) through rhythmization of breathing, heartbeat, and blood pressure. Through this state of coherence, the activity of the parasympathetic nervous system is upregulated, and the activity of the sympathetic nervous system is suppressed, leading to an increase in modulation of ANS activity. Several studies have demonstrated that heart rate variability-biofeedback (HRV-BF) interventions improve HRV, reduce stress and anxiety, and alleviate symptoms in patients with various medical conditions. To the best of current knowledge, no study has investigated the effect of HRV-BF-RFB on glucose metabolism. Therefore, the proposed randomized controlled non-blinded trial aims to gain evidence about the effect of HRV-BF-RFB compared to an anti-stress program on glucose metabolism in individuals with prediabetes. Glucose metabolism is characterized using the 75 g oral glucose tolerance test. There are two potential mechanisms by which HRV-BF-RFB may improve glucose metabolism in individuals with prediabetes: (a) a 0°-phase relationship between heart oscillations and breathing, maximizing the amplitude of respiratory sinus arrhythmia (RSA), and (b) activation of the cholinergic anti-inflammatory pathway. The investigators hypothesized that in individuals with prediabetes, the HRV-BF-RFB intervention will improve glucose metabolism and glucose variability.",[61],[68,240,241,242,243],"glucose metabolism","heart rate variability-biofeedback training","resonance frequency breathing","oral glucose tolerance test",{"date":152,"type":36},{"date":246,"type":36},"2025-05-14",{"date":248,"type":23},"2027-03-31",{"name":250,"class":78},"Johannes Gutenberg University Mainz",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":24,"phases":260,"briefSummary":261,"conditions":262,"keywords":267,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":274,"locationsCount":79},"100434950","human-immunodeficiency-virus-hiv-food-insecurities-100434950","NCT04943861","Human Immunodeficiency Virus (HIV) Food Insecurities","Exploring the Consequences of Food Insecurity and Harnessing the Power of Peer Navigation and mHealth to Reduce Food Insecurity and Cardiometabolic Comorbidities Among Persons With HIV","Inclusion Criteria:\n\n* participant must be a patient of the Wake Forest Infectious Diseases Specialty Clinic\n* be living with HIV\n* ≥18 years of age\n* provide informed consent\n\nExclusion Criteria:\n\n* unable to speak English or Spanish\n* have cognitive impairment that would prevent participation",{"count":259,"type":23},200,[26],"The objectives of this study are to better understand how FI (food insecurities) contributes to the development of cardiometabolic comorbidities among PWH (People with HIV) and to test a novel bilingual FI intervention designed to reduce these comorbidities among food insecure PWH. The PI and staff will conduct this study in partnership with the Wake Forest Infectious Diseases Specialty Clinic, one of the largest Ryan White-funded clinics in North Carolina, which serves more than 2,000 PWH annually from a predominantly rural catchment area that includes South Central Appalachia. This area has high rates of both FI and HIV.",[263,264,265,30,266],"Food Insecurities","Cardiometabolic Comorbidities","HIV","Type 2 Diabetes Mellitus (T2DM)",[268],"Food Insecurity","2026-07-31",{"date":73,"type":36},{"date":272,"type":36},"2023-12-01",{"date":104,"type":23},{"name":275,"class":78},"Wake Forest University Health Sciences",{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":18,"sex":19,"minAge":87,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100549925","small-steps-for-big-changes---healthy-cities-implementation-science-100549925","NCT06440395","Small Steps for Big Changes - Healthy Cities Implementation Science","Small Steps for Big Changes: Implementing an Evidence-Based Diabetes Prevention Program Into Diverse Urban Communities","HCIS","Patients\n\nInclusion Criteria:\n\n* Community-dwelling adults aged 18 years or older\n* able to read and speak English\n* has prediabetes assessed by one of the following means: (a) physician-diagnosed prediabetes, (b) HbA1c values between 5.7 - 6.4% (American Diabetes Association, 2012), (c) an American Diabetes Association risk questionnaire score indicating increased risk (\\>5)\n* Individuals who have previously been diagnosed with type 2 diabetes but who are in remission (defined as achieving glycated hemoglobin (A1C) of \\\u003C 6.4% without any diabetes-related medications for a minimum of 3 months) will be eligible to participate.\n\nExclusion Criteria:\n\n\\- Patients currently diagnosed type 2 diabetes with an HbA1c of 6.5% or greater.\n\nOrganizational partners\n\nInclusion criteria:\n\n\\- Senior leadership and\u002For management of our Canadian YMCA delivery partner organizations\n\nExclusion criteria: N\u002FA\n\nSite leads\u002Fmanagers\n\nInclusion criteria:\n\n\\- YMCA staff who manage\u002Fcoordinate programs (e.g., general manager of health programs) for each site willing to act as SSBC site lead champion.\n\nExclusion criteria: N\u002FA\n\nCoaches\n\nInclusion criteria:\n\nSite staff certified as SSBC coaches to deliver the program.\n\nExclusion criteria: N\u002FA",{"count":285,"type":23},4400,"Small Steps for Big Changes (SSBC) is a diet and exercise counselling program that significantly reduces the risk of developing Type 2 Diabetes (T2D). In partnership with YMCAs in Canada spanning 8 provinces, the aim of this study is to scale-up program delivery and evaluate the implementation and effectiveness of SSBC. To evaluate implementation, the number of staff trained\u002Fpatients enrolled, attendance, sessions delivered as planned, delivery costs, and number of sites continuing to deliver the program will be examined. To evaluate program effectiveness, changes in patient health (e.g., T2D status, blood glucose, weight, exercise, diet) will be measured over 2 years following program completion.",[30],[289,290,291,292,293],"Implementation Science","Exercise Behaviour","Diet Behaviour","Adherence","Health Behaviour Change","2026-07-30",{"date":219,"type":36},{"date":297,"type":36},"2024-06-03",{"date":299,"type":23},"2029-09",{"name":301,"class":78},"University of British Columbia",12,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":18,"sex":19,"minAge":194,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":313,"conditions":314,"keywords":327,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":346},"100650085","health-for-hungary-h4h---longitudinal-collection-of-blood-samples-and-corresponding-data-100650085","NCT07743021","Health for Hungary (H4H) - Longitudinal Collection of Blood Samples and Corresponding Data","Health for Hungary - Longitudinal Collection of Blood Samples and Corresponding Data for Longterm Evaluation of Innovative Diagnostic Techniques in Subjects Without Clinically Relevant Disorders at Baseline to Institute Molecular Fingerprinting Reference Norms","H4H","Low- and Moderate-risk Cohort:\n\nInclusion Criteria:\n\n1. Signed informed consent form (ICF) of the study.\n2. Age \\> 40 years.\n3. Willingness to fill in the study questionnaire.\n4. No clinically relevant symptoms as assessed by the investigator, subjects with existing medical conditions may be eligible given that they are symptom free and that full treatment of the condition is medically confirmed.\n5. Willingness to participate in future visits.\n\nExclusion Criteria:\n\n1. Self-reported pregnancy (no test).\n2. Indications of clinically relevant medical conditions in self-reported healthy subjects.\n3. Self-reported symptom-free HIV, HCV and HBV infections. If HIV, HBV or HCV serology test is done and any of them are positive, the subject will be considered a screen failure.\n4. Any conditions preventing blood-draw.\n5. Vulnerable subjects.\n6. Foreseeable lack of compliance.\n7. Participation in another sample collection project of the same sponsor, in order to avoid double evaluation of the same subject.\n8. Participation (currently or in the past month) in an early phase clinical trial (phases I and II) involving testing of pharmaceutical products, if the last dose of pharmaceutical product administration was within 30 days of the first sample collection, and \u002F or further pharmaceutical product administration is planned.\n9. Vaccination within the last 14 days.\n\nHigh-risk Cohort:\n\nInclusion Criteria:\n\n1. Signed informed consent form (ICF) of the study.\n2. Age \\> 50 years.\n3. Willingness to fill in the study questionnaire.\n4. Willingness to participate in future visits and medical investigations, the presence of at least 2 of the following 3 risk factors (inclusion criteria #5-7):\n5. Hypertension, receiving antihypertensive treatment.\n6. Dyslipidemia\u002F Hypercholesterolemia (\\>5.2mmol\u002FL total cholesterol level), on or not on statin-treatment.\n7. Active or former smoker, with smoking history of at least 20 pack-years, and\u002For the presence of intermediate lung nodule on prior LDCT testing.\n8. No clinically relevant symptoms as assessed by the investigator; subjects with existing medical conditions may be eligible given that they are symptom free and that treatment of the condition is well documented.\n\nExclusion Criteria:\n\n1. Self-reported pregnancy (no test).\n2. Cardiovascular disease (including obstructive coronary artery disease, peripheral artery disease, aortic aneurysm) or other clinically significant heart disease (congenital, valvular heart disease, cardiomyopathy, heart failure and heart disease requiring ICD \\[implantable cardioverter defibrillator\\] or pacemaker therapy).\n3. Interstitial lung disease or severe COPD (chronic obstructive pulmonary disease) in GOLD stages 3 or 4.\n4. Active cancer or malignant disease with less than 5 years history of remission.\n5. Indications of clinically relevant medical conditions in self-reported healthy subjects, especially if (a) the condition requires regular or constant specialist checkups, or (b) pharmacological therapy indicates the presence of significant NCDs or multimorbidity, i.e., chronic polypharmacy (use of 5 or more medications at enrollment or over the last 6 months), or drug therapy necessitating a specialist input for initiation or management (e.g., combined anti-diabetic treatment with two or more medications).\n6. Self-reported symptom-free HIV, HCV and HBV infections. If HIV, HBV or HCV serology test is done and any of them are positive, the subject will be considered a screen failure.\n7. Any conditions preventing blood-draw or CT scans.\n8. Vulnerable subjects.\n9. Foreseeable lack of compliance.\n10. Participation in another sample collection project of the same sponsor, in order to avoid double evaluation of the same subject. 'High-risk' subjects enrolled in the low- and moderate-risk arm of the H4H study might be reallocated to the high-risk study arm after the first 4-5 visits.\n11. Participation (currently or in the past month) in an early phase clinical trial (phases I and II) involving testing of pharmaceutical products, if the last dose of pharmaceutical product administration was within 30 days of the first sample collection, and\u002For further pharmaceutical product administration is planned.\n12. Vaccination within the last 14 days of sample collection.",{"count":312,"type":23},15000,"The Health for Hungary (H4H) study collects blood samples and corresponding health data to investigate healthy aging and health-to-disease transitions in middle-aged and elderly participants.\n\nIndications Studied:\n\nApparently healthy, symptom-free participants are enrolled and followed up to study the onset of new-onset diseases with special emphasis on non-communicable diseases (NCDs).\n\nStudy Design:\n\nSingle-country, multicenter, prospective, longitudinal survey.\n\nObjectives:\n\nThe study aims to establish reference ranges of blood parameters using routine clinical blood tests and high-information-content methods, including proteomics, metabolomics and the so-called infrared molecular fingerprinting.\n\nThe study also aims to identify novel biomarkers of major non-communicable diseases, including atherosclerotic cardiovascular disease, cancer, diabetes and chronic respiratory disease.",[315,316,317,318,319,320,321,322,323,324,62,61,325,326],"Non-communicable Diseases (NCD)","Neoplams","Cancer","Lung Cancer (NSCLC)","Cardiovascular Diseases (CVD)","Atherosclerotic Cardiovascular Disease (ASCVD)","Peripheral Artery Disease (PAD)","Coronary Artery Disease (CAD)","Stroke (CVA) or TIA","Diabetes Mellitus (DM)","Chronic Respiratory Diseases","Chronic Obstructive Pulmonary Disease (COPD)",[328,329,330,331,332,333,334,335,336,337],"Personalized health","Molecular fingerprints","Longitudinal health monitoring","Early-stage disease detection","Innovative research platforms","Precision care","Proteomics","Metabolomics","in vitro diagnostics","Prevention medicine","2026-07-29",{"date":219,"type":36},{"date":341,"type":36},"2021-07-27",{"date":343,"type":23},"2030-12-31",{"name":345,"class":78},"Center for Molecular Fingerprinting Research Nonprofit LLC",33,{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":18,"sex":19,"minAge":354,"maxAge":355,"enrollmentInfo":356,"targetDuration":4,"studyType":24,"phases":358,"briefSummary":359,"conditions":360,"keywords":363,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":79},"100647824","comparative-effects-of-high-intensity-interval-training-and-continuous-endurance-training-among-prediabetic-patients-100647824","NCT07713030","Comparative Effects of High-Intensity Interval Training and Continuous Endurance Training Among Prediabetic Patients","Comparative Effects of High-Intensity Interval Training and Continuous Endurance Training on Glycemic Control, BMI, Vo₂ Max, Pulmonary Function, and Physical Activity Among Prediabetic Patients","Inclusion Criteria:\n\n* Sedentary lifestyle (Individuals reporting minimal structured physical activity e.g., \\\u003C30 minutes of exercise per week) .\n\n  * Stable Medical Condition (No history of significant cardiovascular events, uncontrolled hypertension, or other major comorbidities).\n  * Stable Body Weight (Stable body weight with changes less than 3 kg in the past 6 months).\n\nExclusion Criteria:\n\n* uncontrolled hypertension\n\n  * history of heart disease\n  * myocardial infarction\n  * stroke\n  * Use of Specific Medications (Current use of insulin or other medications affecting glucose metabolism or exercise response)\n  * Severe Obesity (Individuals with a BMI ≥ 40 kg\u002Fm)\n  * High fasting blood glucose (Fasting blood glucose of \\>100mg.dl-1)\n  * Previous history of respiratory problems\n  * Smoking","35 Years","54 Years",{"count":357,"type":23},80,[26],"Prediabetics is a condition where blood sugar levels are normal but not yet high enough to be diagnosed as type 2 diabetes. This phase offers a crucial point for timely intervention to delay or prevent type 2 diabetes. The objective of the study will be to find the effects of high intensity interval and continuous endurance training on glycemic control, BMI, Vo2 Max, pulmonary function and physical activity among prediabetic patients. Study design will be randomized control trial. Total 80 participants will be enrolled in study. The data will be collected from faculty of Riphah International University, Lahore. The study will be completed within 8 months after approval of synopsis. A simple random sampling will be used to assign the groups; group A and group B. Group A will be assigned high intensity interval training and group B will be assigned to continuous training.",[30,361,362],"Pre Diabetes","Prediabetic State",[364,365,366,367,368],"BMI","vo2 Max","glycemic control","Physical Activity","High-Intensity Interval Training","2026-07-17",{"date":371,"type":36},"2026-07-20",{"date":373,"type":36},"2026-05-01",{"date":375,"type":23},"2026-08-01",{"name":377,"class":78},"Riphah International University",{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":19,"minAge":88,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":24,"phases":389,"briefSummary":390,"conditions":391,"keywords":392,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":397,"leadSponsor":399,"locationsCount":79},"100646060","community-dining-walking-and-glucose-in-older-adults-100646060","NCT07695675","Community Dining, Walking, and Glucose in Older Adults","Subsidized Community Dining as Social Welfare Infrastructure for Healthy Aging: A Randomized Crossover Field Study of Postmeal Walking and Glycemic Profiles in Older Adults","CD-WALK","Inclusion Criteria:\n\n* Community-dwelling adults aged 60 to 79 years\n* Eligible for the local elderly meal subsidy\n* Prediabetes or elevated glycemic risk, defined as HbA1c 5.7% to 6.4% or fasting plasma glucose 100 to 125 mg\u002FdL\n* Able to consume meals orally\n* Able to walk independently without a walking aid\n* Able to attend the community dining site safely\n* Able and willing to wear a continuous glucose monitor and activity tracker\n* Able and willing to follow the home-meal plan and study procedures\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* HbA1c ≥6.5% or fasting plasma glucose ≥126 mg\u002FdL\n* Diagnosed diabetes\n* Use of insulin or glucose-lowering medication\n* Severe cognitive impairment\n* Acute illness or recent hospitalization\n* Severe gastrointestinal disease affecting usual food intake or gastric emptying\n* Severe renal, hepatic, cardiovascular, or neurologic disease that would make participation unsafe\n* Skin conditions preventing continuous glucose monitor use\n* Food allergy or dietary restrictions incompatible with the standardized meal plan","79 Years",{"count":388,"type":23},15,[26],"This study will examine whether eating lunch and dinner at a subsidized community dining site affects postmeal walking and blood glucose patterns in older adults. Participants will be community-dwelling adults aged 60 to 79 years who are eligible for a local elderly meal subsidy and have prediabetes or elevated blood glucose risk.\n\nEach participant will complete two 6-day meal conditions in random order. In one condition, participants will eat lunch and dinner at home. In the other condition, participants will eat lunch and dinner at a subsidized community dining site. Participants will wear a continuous glucose monitor and an activity tracker so the study team can measure postmeal glucose levels, daily glucose patterns, and steps after meals.\n\nThe study will compare community dining with home eating to determine whether community dining increases postmeal walking, improves postmeal glucose responses, and affects loneliness and meal experience.",[61],[393,394,175,367],"Older Adults","Postprandial Glucose",{"date":371,"type":36},{"date":375,"type":23},{"date":398,"type":23},"2026-12-31",{"name":400,"class":78},"Yang Zhang",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":19,"minAge":194,"maxAge":233,"enrollmentInfo":408,"targetDuration":4,"studyType":24,"phases":410,"briefSummary":411,"conditions":412,"keywords":413,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":79},"100647986","cardiometabolic--cognitive-effects-of-peanut-butter-in-prediabetes-100647986","NCT07714096","Cardiometabolic & Cognitive Effects of Peanut Butter in Prediabetes","Peanut Butter Glycemic Control, Cognition and Cardiovascular Health","Inclusion Criteria:\n\n* Age 40-65 years\n* BMI 25 to 40 kg\u002Fm2\n* HbA1c 5.7-6.4%\n* Low habitual intake of peanut butter (\\\u003C0.5 Tablespoons\u002Fday on average)\n* Have a smartphone device or be willing to use one provided by the study\n\nExclusion Criteria:\n\n* Hemoglobin \\\u003C13.2 g\u002FdL for men or \\\u003C 11.7 g\u002FdL for women at screening\n* Fasting triglycerides \\>350 mg\u002FdL at screening\n* LDL-cholesterol ≥190 mg\u002FdL assessed by the Martin-Hopkins equation at screening\n* ≥10% change in body weight within the 6 months prior to enrollment\n* Blood pressure \\>140\u002F90 mmHg at screening\n* Diagnosed type 1 or type 2 diabetes\n* Takes any (prescription or over-the-counter) anti-hypertensive, lipid-lowering, glucose-lowering or body weight altering drugs\n* Intake of supplements that affect the outcomes of interest (i.e., lipids, blood pressure, glucose, body weight, and microbiome) and are unwilling to cease during the study period.\n* Unwilling to refrain from starting to take any supplements, vitamins, nutritional products, or health foods that are not prescribed by a doctor for the duration of the study\n* Self-reported history of diagnosed liver, kidney, or autoimmune disease\n* Self-reported history of a prior cardiovascular event (e.g., stroke, heart attack)\n* Self-reported history of diagnosed neurological disease (e.g. Alzheimer's Disease, Parkinson's Disease, Multiple Sclerosis)\n* Current pregnancy or intention of pregnancy within the next 12 months\n* Lactation within the prior 6 months\n* Peanut allergy\u002Fintolerance\u002Fsensitivity\u002Fdislike\n* Antibiotic use within the prior four weeks\n* Oral steroid use within the prior four weeks\n* Use of tobacco or nicotine-containing products within the past 6 months\n* History of cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer within the past 5 years (eligible if ≥5 years without recurrence)\n* Participation in another clinical trial within 60 days of baseline\n* Currently following a restricted or weight-loss diet\n* Prior bariatric surgery\n* Intake of \\>14 alcoholic drinks\u002Fweek and\u002For not willing to avoid alcohol consumption for 48 hours prior to test visits\n* Does not speak and\u002For understand English\n* Unwilling to refrain from donating blood and\u002For plasma during the study\n* Weight \\\u003C110 lb\n* Unwilling to contact study staff before enrolling in other health-related research and avoid participating in any research that may interfere with this study\n* For individuals taking thyroid medication: abnormal thyroid stimulated hormone (TSH) concentration, or change in dose of thyroid medication within the last 6 months\n* Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits",{"count":409,"type":23},56,[26],"The purpose of this study is to look at the effect of consuming peanut butter at breakfast on blood sugar control, cognitive function, and heart disease risk factors in middle-aged adults with prediabetes.",[61],[414,415,416,417,418,366,419,420],"diet","nutrition","peanut butter","cognition","heart disease","cardiovascular disease","diabetes","2026-07-15",{"date":371,"type":36},{"date":424,"type":23},"2027-01-18",{"date":426,"type":23},"2028-10-31",{"name":428,"class":78},"Penn State University",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":88,"enrollmentInfo":435,"targetDuration":4,"studyType":24,"phases":437,"briefSummary":438,"conditions":439,"keywords":444,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":79},"100592056","pilot-study-of-bottarga-supplementation-a-little-known-sustainable-blue-food-100592056","NCT06988462","Pilot Study of \"Bottarga\" Supplementation: A Little-known, Sustainable \"Blue\" Food","* Adults aged 18-60 years\n* Residents of Massachusetts\n* Presence of at least one metabolic abnormality (low HDL cholesterol, elevated LDL cholesterol, elevated triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes\n* Not pregnant\n* Willing to consume a nutritional supplement and comply with study procedures\n\nExclusion Criteria:\n\n* Use of any medications for diabetes (except metformin), dyslipidemia (except statins), or immunosuppression\n* Current use of any supplements containing n-3 fatty acids\n* Current use of illicit drugs (other than marijuana)\n* Use of hormone therapy (except oral contraceptives)\n* Known allergies to fish, seafood, or any fish-derived products, including bottarga\n* Pregnancy\n* Clinical evidence or history of hepatic or renal insufficiency\n* Immunodeficiency conditions\n* History of non-skin cancer\n* Participation in other clinical research studies",{"count":436,"type":23},20,[26],"This pilot study aims to explore the potential benefits of consuming Greek bottarga (grey mullet fish roe) in individuals with at least one metabolic abnormality (low HDL cholesterol, high LDL cholesterol, high triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes.\n\nBefore initiating the crossover randomized controlled trial (RCT), the investigators will conduct a preliminary dose-testing study in five adults with at least one metabolic abnormality. Participants will undergo clinical assessments before and after the dietary intervention to evaluate changes in metabolic health markers. Following this phase, the investigators will proceed with a randomized, controlled crossover trial involving 20 eligible adult participants. This main study phase will compare the metabolic effects of daily bottarga supplementation with those of a calorically matched dairy product over an 8-week intervention period, with a 2-week washout period between interventions.\n\nThe investigators anticipate that bottarga supplementation will improve lipid profiles, inflammation markers, and insulin resistance, thereby supporting the potential use of sustainable blue foods as part of a healthy diet.",[61,440,441,207,442,443],"Diabetes","High Cholesterol\u002FHyperlipidemia","Triglycerides","HDL Cholesterol",[445,446,447,448,449,450,451,452,420],"Bottarga","pre diabetes","inflammation","sustainability","nutritional intervention","overweight","metabolic abnormalities","lipid profile",{"date":454,"type":36},"2026-07-16",{"date":456,"type":36},"2025-10-17",{"date":458,"type":23},"2027-03-01",{"name":460,"class":78},"Cambridge Health Alliance",{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":19,"minAge":53,"maxAge":140,"enrollmentInfo":468,"targetDuration":4,"studyType":24,"phases":470,"briefSummary":473,"conditions":474,"keywords":475,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":493},"100647242","phase-1-safety-and-dose-response-of-bletilla-formosana-in-prediabetic-subjects-100647242","NCT07704944","Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects","A Phase I\u002FII Randomized, Double-Blind, Placebo-Controlled Pilot Trial Evaluating the Safety and Dose-Response of Bletilla Formosana in Prediabetic Subjects","Inclusion Criteria:\n\n1. Adults aged 30-70 years.\n2. Prediabetes defined by any of the following:\n3. Fasting Plasma Glucose (FPG) of 100-125 mg\u002FdL, or\n4. Glycated hemoglobin (HbA1c) of 5.7%-6.4%.\n5. Willingness to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n1. Established type 1 or type 2 diabetes mellitus, or recent use of oral antidiabetic agents or insulin (within 3 months).\n2. Abnormal liver function, defined as Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 2-fold the upper reference limit (≥2 × ULN) at screening.\n3. Abnormal renal function, defined as serum creatinine (Cr) \\>1.5 mg\u002FdL or Estimated Glomerular Filtration Rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m².\n4. Gastrointestinal disorders that may affect drug absorption, such as gastrostomy, enterostomy, severe chronic diarrhea, or malabsorption syndrome.\n5. Severe comorbidities within the past 6 months, including major stroke, myocardial infarction, major trauma, or major surgery.\n6. Recent use of medications (within 1 month) that may significantly alter blood glucose or lipids, such as systemic corticosteroids or non-stable doses of lipid-lowering agents.\n7. Malignant tumor under active treatment, or immunodeficiency\u002Fautoimmune disorders requiring immunosuppressive therapy.\n8. Psychiatric disorders or cognitive impairment that may affect protocol compliance.\n9. Active use of other investigational drugs within 3 months prior to screening.\n10. Pregnancy or lactation.",{"count":469,"type":23},94,[471,472],"PHASE1","PHASE2","This study evaluates the safety and preliminary efficacy of Bletilla formosana (BF), a traditional herbal medicine, in adults with prediabetes. Prediabetes is a high-risk condition where blood sugar levels are elevated, often leading to type 2 diabetes. While lifestyle changes are the standard treatment, researchers are exploring herbal supplements as a complementary way to support metabolic health. Preclinical research has shown that BF possesses anti-inflammatory properties and may help regulate blood glucose. Participants in this study will be randomly assigned to receive either a high dose of BF, a low dose of BF, or a placebo (an inactive substance) for 12 weeks. The total study duration is approximately 24 weeks, involving four clinic visits for blood tests and safety monitoring to see how BF affects blood sugar markers and inflammation.",[61],[61,476,477,478,479,480,481,482,483,484],"Bletilla formosana","Traditional Chinese Medicine","Herbal Medicine","Glycemic Control","Anti-inflammatory","Dose-Response Relationship","Phase I\u002FII Trial","Randomized Controlled Trial","Safety and Tolerability","2026-07-14",{"date":421,"type":36},{"date":488,"type":23},"2026-07-01",{"date":490,"type":23},"2027-08-01",{"name":492,"class":78},"Chang Gung Memorial Hospital",3,{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":140,"enrollmentInfo":501,"targetDuration":4,"studyType":24,"phases":503,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":79},"100491618","metabolic-and-inflammatory-outcomes-of-the-ketogenic-diet-comparing-saturated-and-unsaturated-fat-sources-100491618","NCT05681468","Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources","KETO-IM","Inclusion Criteria:\n\n* Having overweight or obesity and HbA1C ≥ 5.7% at screening\n\nExclusion Criteria:\n\n* Individuals with specific nutritional habits preventing them from adhering to nutritional recommendations\n* Pregnant women\n* People on dialysis or recommended to follow a low-protein diet (base on glomerular filtration rate)\n* Familial hypercholesterolemia or hypertriglyceridemia\n* Transitioning trans-gender\n* For safety purposes, other individuals would be excluded if are under unstable health conditions.",{"count":502,"type":23},175,[26],"The goal of this clinical trial is to compare a healthy KETO diet supplemented with canola oil (KETO-Can) compared to a traditional KETO diet high in saturated fat (KETO-Sat) and low-fat diet (LFD) in adults at high risk of or diagnosed with type 2 diabetes. The main question\\[s\\] it aims to answer are:\n\n* Effects on CVD risk factors (plasma cholesterol, TG, ApoB100, glucose, insulin and HbA1C).\n* Effects on systemic inflammation and immune function.\n* Adherence to interventions.\n\nParticipants will be randomized into 1 of the dietary treatments during which they will follow a Keto or a low-fat diet.\n\nComparisons among groups at 3 and 6 months of intervention will be conducted.",[30,29,506],"Overweight and Obesity",{"date":454,"type":36},{"date":509,"type":36},"2023-09-18",{"date":511,"type":23},"2027-01-31",{"name":513,"class":78},"University of Alberta",{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":19,"minAge":521,"maxAge":233,"enrollmentInfo":522,"targetDuration":4,"studyType":24,"phases":524,"briefSummary":525,"conditions":526,"keywords":527,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":532,"leadSponsor":534,"locationsCount":4},"100610607","mediterranean-diet-and-blood-sugar-study-100610607","NCT07229781","Mediterranean Diet and Blood Sugar Study","Glycemic Effects of a Mediterranean-Style Dietary Pattern Containing Potatoes in Adults With Prediabetes","Inclusion Criteria:\n\n* Age 25-65 years\n* Prediabetes assessed by an HbA1c of 5.7-6.4% or fasting glucose 100-125 mg\u002FdL at screening\n* BMI 25-40 kg\u002Fm2 at screening\n\nExclusion Criteria:\n\n* HbA1c ≥6.5% at screening\n* LDL-C (calculated with the Martin-Hopkins equation) ≥190 mg\u002FdL at screening\n* Hemoglobin \\\u003C13.2 g\u002FdL at screening\n* Fasting triglycerides \\>350 mg\u002FdL at screening\n\n  -≥10% change in body weight within the 6 months prior to enrollment\n* Blood pressure \\>140\u002F90 mmHg at screening\n* Type 1 or type 2 diabetes\n* Prescription of anti-hypertensive, lipid-lowering, or glucose-lowering drugs\n* Intake of supplements that affect the outcomes of interest (i.e., lipid, blood pressure, or glucose lowering; vitamin C or multi-vitamins containing vitamin C) and are unwilling to cease during the study period.\n* History of liver, kidney, or autoimmune disease\n* Prior cardiovascular event (e.g., stroke, heart attack)\n* Current pregnancy or intention of pregnancy within the next 6 months\n* Lactation within the prior 6 months\n* Allergy\u002Fintolerance\u002Fsensitivity\u002Fdislike of any foods in the study menus\n* Antibiotic use within the prior 1 month\n* Oral steroid use within the prior 1 month\n* Use of tobacco or nicotine-containing products within the past 6 months\n* History of cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer within the past 5 years (eligible if ≥5 years without recurrence)\n* Participation in another clinical trial within 60 days of baseline\n* Currently following a restricted or weight-loss diet\n* Prior bariatric surgery\n* Intake of \\>14 alcoholic drinks\u002Fweek and\u002For not willing to avoid alcohol consumption for 48 hours prior to test visits\n* Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits\n* Does not speak and\u002For understand English\n* Unwilling to refrain from donating blood during the study\n* Weight \\\u003C110 lb","25 Years",{"count":523,"type":23},74,[26],"The purpose of this research study is to determine if a healthy Mediterranean diet containing one medium potato\u002Fday has equivalent or non-different effects on risk factors for type 2 diabetes and heart disease compared to a healthy Mediterranean diet without potatoes in adults with prediabetes. Participants will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). Testing will be conducted at the beginning and end of the study.",[61],[68,414,415,528,419],"Mediterranean diet","2026-07-13",{"date":421,"type":36},{"date":375,"type":23},{"date":533,"type":23},"2028-04-30",{"name":428,"class":78},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":19,"minAge":87,"maxAge":195,"enrollmentInfo":543,"targetDuration":4,"studyType":24,"phases":545,"briefSummary":546,"conditions":547,"keywords":549,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":555,"leadSponsor":557,"locationsCount":79},"100635487","risk-informed-shared-decision-making-engagement-strategy-for-patients-with-prediabetes-100635487","NCT07553325","Risk-informed Shared-decision Making Engagement Strategy for Patients With Prediabetes","Pilot Trial of a Risk-informed Shared-decision Engagement Strategy","RISE","Inclusion Criteria:\n\n* prediabetes based on most recent HbA1c (5.7-6.4%) or fasting plasma glucose (100-125 mg\u002FdL) in prior 12 months\n* active patient portal account (MyChart)\n* patient receiving primary care at Johns Hopkins Community Physicians in Frederick\n* have overweight or obesity (BMI ≥ 25 kg\u002Fm2)\n\nExclusion Criteria:\n\n* have diabetes (HbA1c \\> 6.4% in prior 6 months or on diabetes registry)\n* have dementia\n* previously participated in the Diabetes Prevention Program (DPP)",{"count":544,"type":23},120,[26],"The goal of this clinical trial is to learn if knowing risk for diabetes can help adult patients with prediabetes take steps to get care and prevent diabetes. The main questions it aims to answer are:\n\n* Does a shared-decision making visit with a health care team member to talk about the participant's diabetes risk increase participants' taking steps to prevent diabetes?\n* Does a simple message in the patient portal about the participant's diabetes risk increase participants' taking steps to prevent diabetes?\n\nResearchers will compare the visit with usual care at the clinic to see if the visit increases participants' taking steps to prevent diabetes. Separately, the researchers will compare the patient message with usual care at the clinic to see if the message increases participants' taking steps to prevent diabetes.\n\nParticipants will:\n\n* Complete surveys at the beginning of the study and up to 2 additional surveys\n* If the participant falls into the shared decision-making group, the participant will have one 30-minute visit with a healthcare team member to talk about risk of diabetes and how to lower it.",[61,548],"Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)",[550,551,67],"shared decision-making","diabetes risk","2026-07-10",{"date":529,"type":36},{"date":375,"type":23},{"date":556,"type":23},"2028-04-01",{"name":558,"class":78},"Johns Hopkins University",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":18,"sex":19,"minAge":566,"maxAge":87,"enrollmentInfo":567,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":79},"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":502,"type":23},"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.",[570,571,216,572,30],"Type 2 Diabetes","Insulin Resistance","Metabolic Disease",{"date":529,"type":36},{"date":575,"type":36},"2023-09-06",{"date":577,"type":23},"2027-09",{"name":579,"class":78},"University of Michigan",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":19,"minAge":233,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":24,"phases":589,"briefSummary":590,"conditions":591,"keywords":594,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":606,"locationsCount":79},"100592588","study-ehr-risk-stratification-tools-100592588","NCT06995378","Study EHR Risk Stratification Tools","Evaluation of Patient and Provider Facing EHR-embedded Risk Stratification Tools","Inclusion Criteria:\n\n* Age 65 years or older\n* Hemoglobin A1c in the prediabetes range (5.7- but not including 6.0%)\n\nExclusion Criteria:\n\n* Have lab results outside the defined inclusion range\n* No UCLA primary care provider\n* Age \\\u003C65 years\n* Eligibility for Surveys:\n\nAll randomized participants are eligible to receive study surveys. No additional eligibility criteria apply for survey participation.\n\nHgbA1c of 6.0 or above is not eligible.",{"count":588,"type":23},1200,[26],"This study evaluates whether adding machine learning-based risk information to electronic health record (EHR) lab result messages helps older adults better understand their risk of developing diabetes and influences their emotional responses, quality of life, and healthcare use.\n\nEligible participants are adults aged 65 years and older with a UCLA primary care provider and a hemoglobin A1c level in the range (5.7-6.0%). Participants are identified automatically at the time their lab results are processed and are randomly assigned to receive either standard lab result messages or modified messages that include a \"very low risk\" label generated by a machine learning model.\n\nAll participants who are randomized are invited to complete two surveys: one shortly after their lab result is posted in MyChart and a follow-up survey approximately 30 days later. The study also uses de-identified EHR data to examine patterns of healthcare utilization and progression to diabetes. Provider comments related to lab result messaging will be analyzed to explore differences in response patterns between the two groups.",[61,592,593],"Health Communication","Patient Comprehension",[61,595,596,597,598,599,593],"Machine Learning","Risk Stratification","Electronic Health Record","Lab Result Communication","Predictive Modeling","2026-07-07",{"date":602,"type":36},"2026-07-09",{"date":604,"type":36},"2026-05-27",{"date":299,"type":23},{"name":607,"class":78},"University of California, Los Angeles",{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":612,"acronym":4,"eligibilityCriteria":613,"healthyVolunteers":18,"sex":19,"minAge":354,"maxAge":233,"enrollmentInfo":614,"targetDuration":4,"studyType":24,"phases":616,"briefSummary":617,"conditions":618,"keywords":619,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":79},"100413672","phase-2-mechanisms-for-activation-of-beige-adipose-tissue-in-humans-100413672","NCT04666636","Mechanisms for Activation of Beige Adipose Tissue in Humans","Inclusion Criteria:\n\n* BMI 27-45\n* prediabetes (A1c 5.7-6.4)\n* impaired fasting glucose or impaired glucose tolerance\n\nExclusion Criteria:\n\n* diabetes\n* chronic use of anti-diabetic medication\n* acute or chronic inflammatory condition\n* unstable medical condition\n* cancer\n* renal insufficiency\n* any contraindication for Mirabegron\n* BMI \\>45",{"count":615,"type":23},65,[472],"Mirabegron (Myrbetriq®, Astellas) is a highly specific and well-tolerated ß3 agonist marketed for overactive bladder. This trial will assess the effects of mirabegron on glucose tolerance and adipose tissue in prediabetic patients",[30],[620,123,621,622,623,420,624,625],"beige","glucose","fat","BAT","metabolism","DEXA","2026-07-02",{"date":600,"type":36},{"date":629,"type":36},"2020-12-07",{"date":631,"type":23},"2027-12",{"name":633,"class":78},"Philip Kern",{"id":635,"slug":636,"hasResults":12,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":18,"sex":19,"minAge":88,"maxAge":195,"enrollmentInfo":641,"targetDuration":4,"studyType":24,"phases":642,"briefSummary":643,"conditions":644,"keywords":646,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":663,"completionDateStruct":665,"leadSponsor":667,"locationsCount":159},"100634955","effects-of-exogenous-ketones-on-cognitive-function-in-older-adults-with-prediabetes-100634955","NCT07546409","Effects of Exogenous Ketones on Cognitive Function in Older Adults With Prediabetes?","Can Exogenous Ketone Supplementation Compensate for Glucose Hypometabolism and Improve Cognitive Processing Speed in Veterans With Prediabetes?","Inclusion Criteria:\n\n* Age 60 to 75 years\n* Able to provide written informed consent\n* Fluent in English\n* No diagnosed cognitive impairment or dementia\n\nClassified as either:\n\n* Prediabetes (based on American Diabetes Association criteria), or Normal glucose regulation (control group)\n* Medically stable and cleared to undergo positron emission tomography and magnetic resonance imaging\n* Willing to comply with study procedures, including metabolic testing, supplement ingestion, and neuroimaging\n\nExclusion Criteria:\n\n* Diagnosis of mild cognitive impairment, dementia, or other neurodegenerative disorder\n* Diagnosis of type 1 diabetes or type 2 diabetes\n* Use of glucose-lowering medications (e.g., insulin, metformin, glucagon-like peptide-1 receptor agonists)\n* History of major neurological disorder (e.g., stroke, traumatic brain injury with loss of consciousness \\>30 minutes, epilepsy, multiple sclerosis)\n* Major psychiatric disorder not stable on treatment\n* Uncontrolled hypertension or significant cardiovascular disease\n* Severe renal, hepatic, or gastrointestinal disease that may affect supplement metabolism\n* Contraindications to magnetic resonance imaging (e.g., non-compatible implanted devices, severe claustrophobia)",{"count":436,"type":23},[26],"Brief Summary\n\nThe goal of this clinical trial is to learn whether older adults with prediabetes, but no diagnosed cognitive impairment, show early changes in brain energy use and thinking speed compared to older adults with normal blood sugar levels. The study will also test whether a single dose of an exogenous ketone supplement can improve brain energy use and cognitive processing speed.\n\nThe main questions it aims to answer are:\n\nDo older adults with prediabetes have lower brain glucose uptake and slower cognitive processing speed compared to those with normal glucose levels?\n\nDoes a single dose of an exogenous ketone monoester supplement improve cognitive processing speed and brain glucose uptake?\n\nResearchers will compare older adults with prediabetes to older adults with normal glucose levels to determine whether differences exist in brain glucose metabolism and cognitive performance. In a subset of participants, researchers will also compare brain and cognitive outcomes before and after consuming a ketone monoester supplement (DeltaG, Oxford, England).\n\nParticipants will:\n\nComplete metabolic testing to determine glucose status\n\nUndergo brain imaging using fluorodeoxyglucose positron emission tomography combined with magnetic resonance imaging (18FDG-PET\u002FMRI) while performing a cognitive processing speed task\n\nConsume a single dose of a commercially available ketone monoester supplement during one study visit\n\nComplete cognitive testing during imaging to measure processing speed and brain activity\n\nThe results of this study will help determine whether early metabolic dysfunction is linked to reduced brain energy use and whether ketones can temporarily support brain function in individuals at risk for dementia.",[61,645],"Healthy (Controls)",[362,571,647,648,649,650,651,652,653,654,655,656,657,658,659,660],"Brain Glucose Metabolism","Cerebral Glucose Uptake","Fluorodeoxyglucose F18","Positron-Emission Tomography","Magnetic Resonance Imaging","Functional Magnetic Resonance Imaging","Cognitive Dysfunction","Dementia","Aging","Processing Speed","Ketone Bodies","beta-Hydroxybutyrate","Neuroimaging","Brain Energy Metabolism","2026-06-30",{"date":626,"type":36},{"date":664,"type":36},"2025-05-20",{"date":666,"type":23},"2027-05-31",{"name":668,"class":78},"University of Alabama at Birmingham",{"id":670,"slug":671,"hasResults":12,"nctId":672,"briefTitle":673,"officialTitle":674,"acronym":675,"eligibilityCriteria":676,"healthyVolunteers":18,"sex":19,"minAge":194,"maxAge":140,"enrollmentInfo":677,"targetDuration":4,"studyType":24,"phases":679,"briefSummary":680,"conditions":681,"keywords":683,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":687,"lastUpdatePostDateStruct":688,"startDateStruct":689,"completionDateStruct":691,"leadSponsor":693,"locationsCount":79},"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":678,"type":23},82,[26],"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.",[61,571,442,682],"Lipids Metabolism",[442,684,685,686],"Insulin resistance","Glucose metabolism","Lipids metabolism","2026-06-29",{"date":488,"type":36},{"date":690,"type":36},"2026-06-03",{"date":692,"type":23},"2027-12-31",{"name":694,"class":43},"Clinical Nutrition Research Center, Illinois Institute of Technology",{"id":696,"slug":697,"hasResults":12,"nctId":698,"briefTitle":699,"officialTitle":699,"acronym":700,"eligibilityCriteria":701,"healthyVolunteers":18,"sex":19,"minAge":87,"maxAge":4,"enrollmentInfo":702,"targetDuration":4,"studyType":24,"phases":703,"briefSummary":704,"conditions":705,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":707,"lastUpdatePostDateStruct":708,"startDateStruct":709,"completionDateStruct":711,"leadSponsor":713,"locationsCount":79},"100524940","ketogenic-diet-and-diabetes-demonstration-project-100524940","NCT06115265","Ketogenic Diet and Diabetes Demonstration Project","KDDP","Inclusion Criteria:\n\n* Men and women ≥ 18 years old\n* BMI ≥27 kg\u002Fm2\n* Hemoglobin A1c ≥ 5.7% and\u002For fasting plasma glucose of 100-125 mg\u002FdL\n\nExclusion Criteria:\n\n* Known clinical cardiovascular disease (i.e. prior stroke, myocardial infarction, peripheral artery disease)\n* LDL cholesterol ≥ 190 mg\u002FdL\n* Triglycerides ≥ 500 mg\u002FdL\n* History of type 1 diabetes\n* History of diabetic ketoacidosis\n* Individuals requiring insulin\n* Advanced renal disease\n* Advanced liver disease\n* Terminal cancer\n* Pregnancy",{"count":116,"type":23},[26],"KDDP is a prospective, 12-month pilot study comparing the effects of a novel lifestyle program, the Ketogenic Diet and Diabetes Demonstration Project (KDDP) to those of the National Diabetes Prevention Program (NDDP). KDDP is modeled to mimic the delivery platform of NDPP with the exception that participants in KDDP will be placed on a medically-supervised ketogenic diet, and participants in NDPP will be placed on a low fat diet.\n\nThe purpose of this study is to compare the metabolic effects of the KDDP and the NDPP on glycemic control, lipid parameters, blood pressure, heart rate, weight, and coronary artery calcium scores in individuals with either type 2 diabetes or prediabetes.",[570,30,216,706],"Ketogenic Dieting","2026-06-26",{"date":661,"type":36},{"date":710,"type":36},"2023-09-05",{"date":712,"type":23},"2026-10-01",{"name":714,"class":78},"University of New Mexico"]