[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prediabetes--type-2-diabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prediabetes--type-2-diabetes":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,76,107,139,191,217,243,275,301],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100644451","health-assessment-of-low-glycaemic-index---high-protein-rice-to-enhance-glycemic-control-through-nutrition-100644451",false,"NCT07663123","Health Assessment of Low Glycaemic Index - High Protein Rice to Enhance Glycemic Control Through Nutrition","Health Assessment of Low Glycaemic Index - High Protein Rice to Enhance Glycemic Control Through Nutrition (HARVEST) Study","HARVEST","Inclusion Criteria:\n\n1. Males or females, aged 40 to 65 years old\n2. Chinese, Malay or Indian\n3. Body Mass Index between 23.0 - 32.0 kg\u002Fm2\n4. Prediabetes profile as per fasting plasma glucose (≤ 6.9 mmol\u002FL) and HbA1c level (5.7% - 6.4%)\n5. Habitually consuming about 3 to 5 servings of polished white rice per day\n6. No known food allergies and intolerance to food provided as part of study procedures\n7. Proficient in English language\n8. Willing to comply to study procedures and provide written consent\n\nExclusion Criteria:\n\n1. Diagnosed with Type 1 or 2 diabetes mellitus\u002F OGTT failure during screening visit\n2. History or current diagnosis of cardiovascular, endocrine, gastrointestinal, haematological, hepatitis (hepatitis B and C), cancers (except basal cell carcinoma), chronic kidney disease or other medical conditions which may affect study outcomes, as assessed by study team\n3. Having chronic medication (eg: metformin, oral corticosteroids etc), and\u002For supplements that may influence glycaemic management and other study outcomes, as assessed by study team\n4. History of bariatric surgery\n5. Significant weight change (± 5 % body weight) during the last 3 months\n6. Women who are pregnant, breastfeeding or planning pregnancy\n7. Drug abuse within the last 5 years\n8. Excessive alcohol consumption \\> 2 servings per day\n9. Smoking in the last 1 year\n10. Following any special diet(s) which may interfere with study outcomes (eg: Ketogenic diet, intermittent fasting, calorie-deficit)\n11. Major change in physical activity and\u002For dietary habits in the last 3 months\n12. Use of oral antibiotics in the last 3 months\n13. Participation in other intervention studies, which may affect study outcomes as assessed by study team\n14. Staff of IHDP and SIFBI in A\\*STAR","ALL","40 Years","65 Years",{"count":21,"type":22},225,"ESTIMATED","INTERVENTIONAL",[25],"NA","Type 2 Diabetes (T2D) represents a critical public health challenge in Singapore, with prevalence projected to reach one million residents by 2050. This epidemic is largely driven by a distinct \"Asian phenotype\" characterized by reduced insulin secretion capacity even at lower BMIs and a diet heavily centered on high-glycemic index (GI) white rice. While brown rice offers superior nutritional benefits, its global and local adoption remains low due to entrenched cultural preferences, shorter shelf life, and sensory barriers.\n\nWhile the link between high-GI carbohydrates and metabolic dysfunction is well-documented, there is limited clinical evidence on the effects of \"functional\" white rice varieties specifically those engineered to combine low GI properties with significantly enhanced protein content on long-term glycemic control, metabolic and gut microbiome health in Asian populations. The importance of this research lies in its evaluation of a culturally seamless substitution strategy. By replacing conventional white rice with Low-GI (LGI) and High-Protein Low-GI (LGI-HP) varieties, the HARVEST study addresses the metabolic burden of prediabetes without requiring major behavioral shifts. The findings will provide vital mechanistic insights into glucose regulation, insulin sensitivity, and microbial dysbiosis, to provide the evidence based for nutritional strategies for T2D prevention and management.",[28],"Prediabetes \u002F Type 2 Diabetes",[30,31,32,33],"Prediabetes","Type 2 Diabetes prevention","Nutrition","Metabolic dysfunction","NOT_YET_RECRUITING","2026-06-17",{"date":37,"type":38},"2026-06-23","ACTUAL",{"date":40,"type":22},"2026-08-10",{"date":42,"type":22},"2029-04-30",{"name":44,"class":45},"Institute for Human Development and Potential (IHDP), Singapore","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100641829","cgm-guided-patch-pump-vs-basal-bolus-injection-for-steroid-induced-hyperglycemia-in-sudden-sensorineural-hearing-loss-ship-trial-100641829","NCT07652528","CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial","Steroid-induced Hyperglycemia Management With Insulin Patch Pump in Sudden Sensorineural Hearing Loss: a CGM-guided Exploratory Randomized Controlled Trial (SHIP Trial)","SHIP","Inclusion Criteria:\n\n1. Age ≥19 years\n2. Idiopathic SSNHL: ≥30 dB sensorineural hearing loss across ≥3 consecutive frequencies within 72 hours\n3. Affected ear PTA4 (mean of 0.5\u002F1\u002F2\u002F4 kHz) ≥40 dB HL (moderate or greater)\n4. Planned methylprednisolone 48 mg\u002Fday orally once in the morning\n5. At least one of: known T2DM; HbA1c 5.7-10.0% within 3 months; POC glucose ≥140 mg\u002FdL ×2 (≥2h apart, ≥1 postprandial) within 24h of steroid\n6. If on prior insulin: outpatient TDD ≤30 U\u002Fday\n7. Able to eat ≥2 meals\u002Fday, wear CGM and patch pump, use smartphone\n8. Willing to undergo 2-night inpatient admission (Day 1-3)\n9. Written informed consent\n\nExclusion Criteria:\n\n1. Type 1 DM, LADA, pancreatogenic DM, DKA\u002FHHS within 12 months, ketonuria at enrollment\n2. Enrollment POC ≥350 mg\u002FdL or immediate IV insulin requirement\n3. HbA1c ≥10.0%\n4. eGFR \\\u003C30 mL\u002Fmin\u002F1.73m² or dialysis\n5. Pregnancy\u002Fbreastfeeding; women of childbearing potential: positive urine hCG\n6. ICU, sepsis, NPO, TPN\u002Fenteral nutrition\n7. Severe hepatic failure (Child-Pugh C)\n8. Dexamethasone, divided-dose, or pulse steroids planned\n9. Prior CSII or AID device user\n10. Skin adhesive allergy precluding CGM or patch pump use\n11. Insufficient cognitive function for device or dosing table use\n12. Planned MRI requiring repeated CGM\u002Fpump removal\n13. PTA \\>70 dB (profound hearing loss requiring combined intratympanic steroid)","19 Years",{"count":56,"type":22},44,[25],"This exploratory randomized controlled trial evaluates whether a CGM-guided temporary patch pump (CareLevo CSII) reduces glucocorticoid-induced hyperglycemia (GIH) compared to a Lantus-based basal-bolus injection (MDI) regimen in patients with sudden sensorineural hearing loss (SSNHL) and type 2 diabetes or prediabetes receiving high-dose systemic corticosteroids (methylprednisolone 48 mg\u002Fday).\n\nPatients with SSNHL are treated with high-dose oral corticosteroids as standard of care, which often causes significant postprandial hyperglycemia - particularly in patients with pre-existing diabetes or prediabetes. No randomized trial has investigated the optimal insulin delivery strategy for this specific clinical scenario.\n\nAll enrolled participants undergo a 2-night inpatient admission (Day 1-3) for safe insulin initiation and device education, followed by outpatient management (Day 4-14). All participants wear a CareSens Air continuous glucose monitor (CGM, 15-day sensor) throughout Day 1-14.\n\nParticipants meeting insulin activation criteria are randomized 1:1 to:\n\n* Arm A (CSII): CareLevo patch pump using a steroid-wave basal profile and carbohydrate-band meal bolus via the app's bolus calculator (CGM-integrated, IOB-adjusted)\n* Arm B (MDI): Insulin glargine U-100 (Lantus) qAM plus Fiasp prandial bolus via pen using a pre-printed dose table with identical carbohydrate-band algorithm\n\nBoth arms use identical glycemic targets, carbohydrate-band bolus algorithm (ICR\u002FISF identical), and correction rules. The primary difference is insulin delivery (patch pump vs. pen injection) and basal profile (steroid-wave CSII vs. flat glargine). The primary outcome is 24-hour CGM Time Above Range (TAR) \\>180 mg\u002FdL averaged over the 9-day high-dose steroid period (Day 1-9).",[60,28],"Sudden Sensorineural Hearing Loss (SSNHL)",[62,63,64,65,66,67],"Sudden Sensorineural Hearing Loss","Glucocorticoid-Induced Hyperglycemia","Steroid-Induced Hyperglycemia","Continuous Glucose Monitoring","Insulin Pump Therapy","Patch Pump","2026-06-11",{"date":35,"type":38},{"date":71,"type":22},"2026-08",{"date":73,"type":22},"2028-12",{"name":75,"class":45},"Hallym University",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":19,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100640540","effects-of-exercise-snacks-on-clinical-and-health-outcomes-100640540","NCT07609290","Effects of Exercise Snacks on Clinical and Health Outcomes","Effects of Exercise Snacks on Clinical and Health Outcomes in Sedentary Populations With Chronic Diseases","Inclusion Criteria:\n\n1. Age 18 to 65 years.\n2. Diagnosed with diabetes mellitus (HbA1c ≥ 6.5%) or prediabetes (HbA1c ≥ 5.7%).\n3. Engaging in less than 1 hour of physical activity per week in the past 3 months, assessed by the International Physical Activity Questionnaire (IPAQ).\n4. Sedentary behavior defined as sitting for ≥ 6 hours per day or walking fewer than 5,000 steps per day on average.\n5. Able to use a smartphone and operate related mobile applications.\n6. Able to provide informed consent and willing to participate in the study.\n\nExclusion Criteria:\n\n1. History of heart disease, kidney disease, pregnancy, cancer, lower limb joint disease, or psychiatric disorders.\n2. Musculoskeletal or neurological disorders that limit independent physical activity or exercise.\n3. Acute or terminal illness that may affect participation in the study, such as ongoing cancer treatment, acute myocardial infarction, acute stroke, or receiving palliative care.\n4. Unstable or uncontrolled cardiovascular, metabolic, or respiratory diseases, such as unstable angina, uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg), heart failure, severe chronic obstructive pulmonary disease, or acute exacerbation of respiratory disease.\n5. Presence of metal implants in the body.\n6. Body mass index (BMI) ≥ 35 kg\u002Fm².\n7. Unable to use a smartphone or mobile applications.","18 Years",{"count":85,"type":22},58,[25],"Physical inactivity and prolonged sedentary behavior are major health concerns, especially for individuals with chronic conditions such as diabetes and prediabetes. Many patients have difficulty following traditional exercise recommendations due to time constraints, limited physical capacity, comorbidities, or lack of access to exercise facilities. Therefore, new and more practical exercise strategies are needed.\n\n\"Exercise Snacks\" is a novel physical activity approach that involves short bouts of exercise performed multiple times throughout the day. Each session is brief and easy to integrate into daily life, such as performing short periods of resistance exercises, brisk walking, stair climbing, or other simple activities. This approach may improve exercise adherence and provide health benefits without requiring long exercise sessions.\n\nThe purpose of this study is to evaluate the feasibility and acceptability of an Exercise Snacks intervention in sedentary adults with diabetes or prediabetes and to explore its potential effects on cardiovascular and metabolic health, physical function, and body composition.\n\nIn this study, sedentary adults aged 18-65 years with diabetes or prediabetes will participate in a 12-week study and will be randomly assigned to either an Exercise Snacks group or a control group. Participants in the Exercise Snacks group will perform short exercise sessions lasting approximately 3-5 minutes, including simple resistance exercises and short aerobic activities. These exercise sessions will be performed several times per day and integrated into daily routines. The control group will maintain their usual lifestyle without additional exercise intervention.\n\nParticipants may use wearable devices or mobile applications to receive reminders and record exercise activity. Assessments will be conducted before and after the intervention to evaluate physical activity adherence, physical function, body composition, blood pressure, blood glucose, and other cardiovascular and metabolic health indicators.\n\nThis study aims to determine whether short, frequent exercise sessions are a practical and effective alternative to traditional exercise recommendations for sedentary individuals with diabetes or prediabetes. The results of this study may help develop more feasible lifestyle intervention strategies to improve long-term exercise adherence and overall health in individuals with chronic diseases.",[28,89,90],"Sedentary Behaviors","Physical Inactivity",[92,93,94,95,30,96],"Exercise Snacks","Physical activity","Sedentary behavior","Diabetes","Cardiovascular metabolism","2026-05-21",{"date":99,"type":38},"2026-05-27",{"date":101,"type":22},"2026-05-15",{"date":103,"type":22},"2026-12-31",{"name":105,"class":45},"Chimei Medical Center",1,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100637978","triglyceride-rich-lipoproteins-and-inflammatory-cytokines-after-oral-fat-loading-as-potential-early-biomarkers-of-the-risk-of-progression-towards-diabetes-and-development-of-complications-lipinfat-diabetes-study-100637978","NCT07602023","Triglyceride-rich LIPoproteins and INflammatory Cytokines After Oral FAT Loading as Potential Early Biomarkers of the Risk of Progression Towards DIABETES and Development of Complications. LIPINFAT Diabetes Study.","LIPINFAT","Inclusion Criteria:\n\n* Males and females aged 50-70 years\n* BMI between 25-30 kg\u002Fm2\n* HbA1c ≤7% for T2D\n* HbA1c ≤6.5% for prediabetes\n* HbA1c ≤5.7% for controls\n* Signed Project Information and Informed Consent Form\n* Signed Data Processing Consent Form\n\nExclusion Criteria:\n\n* Lipid-lowering therapy with ezetimibe, fenofibrate, omega-3 fatty acids, or other drugs that can interfere with lipoprotein absorption and metabolism\n* Chronic Kidney Disease (CKD) with estimated glomerular filtration rate (eGFR) \\\u003C60 ml\u002Fmin and renal impairment (e.g., uACR ≥30 mg\u002Fmmol) for 3 months or more\n* Secondary or syndromic forms of obesity\n* Patients on insulin therapy\n* All acute and chronic conditions that, in the opinion of the investigators, may cause bias.\n* Hospitalization for acute illness or major surgery in the last 6 months\n* Patients on stable therapy for less than 3 months\n* Allergy or intolerance to one or more components of the meal used in the protocol\n* Pregnancy or breastfeeding\n* Habitual consumption of alcoholic beverages (\\>20 g\u002Fday for females and \\>30 g\u002Fday for males) or unwillingness to abstain from alcoholic beverages during the study run-in period\n* All subjects who do not consent to participate in the study","50 Years","70 Years",{"count":117,"type":22},150,"OBSERVATIONAL","The aim of the study is to evaluate whether the Oral Fat Loading Test (OFLT) determines a different response in terms of the quantity, quality, and kinetics of triglyceride-rich lipoproteins in subjects with T2D, prediabetics, and control subjects, and whether triglyceride-rich lipoproteins and inflammatory cytokines after OFLT are potential early biomarkers of the risk of progression to diabetes and the development of complications in a general practice setting.\n\nTo address these questions, a hybrid cohort study was designed by identifying three groups of subjects: T2D and prediabetics (exposed and near-exposed) and control subjects (unexposed).",[28],[122,123,124,125,126,127],"Prediabetes, Type 2 diabetes","Oral Fat Load test","Tryglicerides","Cytokines","lipoproteins","VLDL","RECRUITING","2026-05-14",{"date":131,"type":38},"2026-05-22",{"date":133,"type":38},"2024-05-14",{"date":135,"type":22},"2028-05-14",{"name":137,"class":45},"Angelina Passaro",2,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":147,"sex":17,"minAge":18,"maxAge":115,"enrollmentInfo":148,"targetDuration":4,"studyType":23,"phases":150,"briefSummary":152,"conditions":153,"keywords":158,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":106},"100638542","phase-2-effects-of-different-fish-oil-types-on-type-2-diabetes-risk-factors-in-high-risk-adults-100638542","NCT07575438","Effects of Different Fish Oil Types on Type 2 Diabetes Risk Factors in High-Risk Adults","Role of EPA and DHA as Tailored Therapy for People Living With Obesity and High-risk for Type 2 Diabetes (END-T2D): a Randomized Controlled Trial","END-T2D","Inclusion Criteria:\n\nMales and post-menopausal females:\n\n* With a body mass index (BMI \\>25-40 kg\u002Fm2)\n* Having confirmed menopausal status (FSH ≥ 30 U\u002Fl)\n* Non-smokers (tobacco) or have quitted for over a year\n* Low-moderate alcohol consumption: \\\u003C7 alcoholic servings\u002F week\n* Plasma apoB ≥1.05 g\u002FL\n\nExclusion Criteria:\n\n* Elevated risk of cardiovascular disease (≥ 20% of calculated Framingham Risk Score)\n* Prior history of cardiovascular events (e.g. stroke, transient ischemic attack, myocardial infarction, angina, heart failure, arrhythmias, flutter, atrial …)\n* Systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg\n* Diabetes or HbA1c ≥ 6.5%\n* Reactive hypoglycaemia\n* Prior history of cancer within the last 3 years or if lymph nodes were removed\n* Thyroid disease - untreated or unstable Synthroid dose\n* Severe renal dysfunction - eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n* Hepatic dysfunction - AST\u002FALT \\> 3 times normal limit\n* Anemia - Hb \\\u003C 120 g\u002FL in females and \\\u003C 130 in males\n* Bleeding disorders\n* Blood coagulation problems (i.e. bleeding predisposition)\n* Malabsorptive disease or surgeries (e.g. bariatric surgeries)\n* Autoimmune and chronic inflammatory disease (i.e. celiac, inflammatory bowel, Graves, multiple sclerosis, psoriasis, rheumatoid arthritis, and lupus).\n* Chronic diarrhea\n* Cholecystectomy (e.g. removal of gall bladder)\n* Sleep apnea\n* Seizures\n* Known history of difficulties accessing a vein\n* Known history of vagal shock or loss of consciousness during blood withdrawal\n* Concomitant medications (systemic corticosteroids; hypertension medication; anti-psychotic medications - psycho-active medication that promote weight gain; anticoagulant or anti-aggregates treatment (e.g. aspirin, NSAIDs, warfarin, coumadin..); systemic adrenergic agonists; weight-loss medication (e.g. GLP-1 agonists); lipid lowering medication (e.g. statins, anti-PCSK9); )\n* Allergy to seafood\u002Ffish or corn oil\n* Allergy to bovine gelatine or glycerine (softgel components)\n* Allergy to Xylocaine (anesthesia used during fat tissue biopsy)\n* Anticipated surgery or blood transfusion\n* Known substance abuse\n* Very high physical activity (\\> 5 hours of aerobic exercise per week)\n* Already taking more than 1 gm of EPA and\u002For DHA supplementation per day\n* Lack of compliance to the study requirements (i.e. not being fasting)\n* Cancellation of the same scheduled testing visit more than once\n* Lack of time to participate in the full length of the study (18-22 weeks)\n* Other conditions deemed inappropriate by the study physician (e.g. difficulties in understanding\u002Fcommunicating in French or English)",true,{"count":149,"type":22},84,[151],"PHASE2","The purpose of this clinical trial is to find out whether one type of fish oil works better than another at improving metabolic health in people who are at high risk of developing type 2 diabetes.\n\nSome metabolic problems-such as difficulty controlling blood sugar, unhealthy particles that transport cholesterol in the blood, and poor fat tissue function-can increase the risk of type 2 diabetes. This study aims to determine whether different types of fish oil can:\n\n1. Improve how well the body produces insulin and responds to it,\n2. Improve the quality of the particles that carry \"bad\" cholesterol in the blood, and 3) Improve the health and function of participants' fat tissue.\n\nTo answer these questions, researchers will compare the effects of two types of fish oil: EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). These will be compared with corn oil, which is used as a placebo and does not contain EPA or DHA.\n\nWhen included in this study, participants will:\n\nA) Take softgel capsules containing EPA, DHA, or placebo (corn oil) every day for 12 weeks, B) Keep a daily log to record when they take their study softgels, and C) Visit the research unit six times, including one and a half days before and after the intervention, to complete specialized metabolic tests that are mostly only available in research settings.",[154,155,28,156,157],"Type 2 Diabetes","Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)","Obesity & Overweight","Obesity and Diabetes Mellitus, Type 2",[159,160,161,162,163,164,165,166,167,168,169,170,171,172,30,173,174,175,176,177,178,179,180,181],"Omega-3 fatty acids","EPA","DHA","Low-density lipoproteins","LDL","Overweight","Obesity","Insulin secretion","Insulin sensitivity","LDL size","LDL diameter","Inflammation","White adipose tissue","HyperapoB","Botnia clamp","Intravenous glucose tolerance test","Hyperinsulinemic euglycemic clamp","Adipose tissue needle biopsy","Oral glucose tolerance test","Eicosapentaenoic acid","Docosahexaenoic acid","High plasma apoB","Disposition index","2026-05-08",{"date":184,"type":38},"2026-05-12",{"date":186,"type":22},"2026-07",{"date":188,"type":22},"2029-12",{"name":190,"class":45},"May Faraj, PDt, PhD",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":106},"100569431","whey-protein-ingestion-and-glucose-control-in-pre--and-post-diabetic-individuals-100569431","NCT06694155","Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals","DAIRY","Inclusion Criteria:\n\n1. Males and females ages 50-70 years.\n2. Body mass index between 25-45 kg\u002Fm2\n3. Capable of providing informed consent.\n4. COVID-19 negative and\u002For asymptomatic.\n5. Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 7-day study meal period on two occasions.\n6. HbA1c: 5.7-6.4% or 6.5% to 7.5% or fasting glucose ≥100 mg\u002FdL\n\nExclusion Criteria:\n\n1. Subject who does not\u002Fwill not eat dairy protein sources.\n2. Subjects taking exogenous insulin injections or GLP \u002FGIP injections or other appetite suppressants.\n3. Unwilling to keep a detailed 7 day food journal on two occasions\n4. Unwilling to wear a CGM for 7 days on two occasions and share the data with the research team.\n5. Lactose intolerance.\n6. Hemoglobin \\\u003C10g\u002FdL at screening.\n7. History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.\n8. History of gastrointestinal bypass\u002Freduction surgery.\n9. Pregnant or lactating individuals.\n10. History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)\n11. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.\n12. Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).\n13. Unwilling to avoid using protein or amino-acid supplements during participation.\n14. Unwilling to fast overnight.\n15. Any medical condition or medication that the PI or clinical study staff finds contradictory to this study.",{"count":199,"type":22},40,[25],"To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals",[28],[204,205,206,207],"Whey Protein","type II diabetes","Protein turnover","Dietary intake","2026-04-03",{"date":210,"type":38},"2026-04-06",{"date":212,"type":38},"2025-01-15",{"date":214,"type":22},"2027-03-01",{"name":216,"class":45},"University of Arkansas",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":106},"100608010","a-clinical-trial-to-examine-the-efficacy-and-safety-of-an-investigational-product-with-and-without-use-of-semaglutide-on-glycemic-response-in-adults-with-prediabetes-or-type-2-diabetes-100608010","NCT07195994","A Clinical Trial to Examine the Efficacy and Safety of an Investigational Product With and Without Use of Semaglutide on Glycemic Response in Adults With Prediabetes or Type 2 Diabetes","A Randomized, Single-blind, Controlled, Parallel Clinical Trial to Examine the Efficacy and Safety of an Investigational Product With and Without Use of Semaglutide on Glycemic Response in Adults With Prediabetes or Type 2 Diabetes","Inclusion Criteria:\n\n1. Males \\& females between 18 years of age or older\n2. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening\n\n   Or,\n\n   Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:\n   * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)\n   * Double-barrier method\n   * Intrauterine devices\n   * Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)\n   * Vasectomy of partner at least 6 months prior to screening\n   * Abstinence and agrees to use contraception if becomes sexually active during this study\n3. Individuals eligible for, but not currently taking, semaglutide therapy as per standard-of-care including adults with:\n\n   1. Prediabetes (HbA1c 6.0-6.5%) who are treatment naïve\n   2. Type 2 Diabetes (HbA1c 6.5-7.5%) who are treatment naïve and metformin is inappropriate due to contraindication or intolerance\n4. Self-reported stable body weight defined as not having gained or lost more than 5 kg of body weight in the three months prior to baseline\n5. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, sleep, use of nicotine, tobacco and cannabinoid products) as much as possible throughout the study\n6. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits\n7. Provided voluntary, written, informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study\n2. Allergy, sensitivity, intolerance, or dietary restriction preventing use of study products\n3. Personal or family history of MTC or in patients with MEN 2\n4. Unstable metabolic disease or chronic diseases as assessed by the QI\n5. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI\n6. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)\n7. Type I diabetes or diabetic ketoacidosis\n8. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis\n9. History of or current diagnosis with kidney and\u002For liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months\n10. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI\n11. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI\n12. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable\n13. Individuals with an autoimmune disease or are immune compromised\n14. Self-reported confirmation of a HIV-, Hepatitis B- and\u002For C-positive diagnosis as assessed by the QI\n15. Self-reported confirmation of blood\u002Fbleeding disorders as assessed by the QI\n16. Alcohol intake average of \\>2 standard drinks per day as assessed by the QI\n17. Alcohol or drug abuse within the last 12 months\n18. Current use of prescribed and\u002For over-the-counter (OTC) medications, supplements, and\u002For consumption of food\u002Fdrinks that may impact the efficacy and\u002For safety of the study products (See Section 7.3)\n19. Clinically significant abnormal laboratory results at screening as assessed by the QI\n20. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit\n21. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI\n22. Individuals who are unable to give informed consent\n23. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant",{"count":225,"type":22},90,[25],"This is a randomized, single-blind, controlled, parallel clinical trial to examine the efficacy and safety of AMPK Charge+® with and without use of semaglutide on glycemic response in adults with prediabetes or Type 2 Diabetes. The main question it aims to answer is:\n\nWhat is the difference in change in fasting blood glucose and insulin, and hemoglobin A1c (HbA1c) from baseline at Day 84 between AMPK Charge+® and AMPK Charge+® with semaglutide?\n\nParticipants will consume AMPK Charge+® with or without semaglutide injections and will be evaluated for glycemic response parameters.",[28],[30,230,231,232],"AMPK Charge+®","Semaglutide","GLP-1 agonist","2026-03-12",{"date":235,"type":38},"2026-03-16",{"date":237,"type":38},"2026-02-05",{"date":239,"type":22},"2026-09",{"name":241,"class":242},"QuickSilver Scientific","INDUSTRY",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":4},"100621936","effects-of-sweetener-consumption-on-risk-factors-for-heart-disease-in-prediabetic-subjects-100621936","NCT07377097","Effects of Sweetener Consumption on Risk Factors for Heart Disease in Prediabetic Subjects","Effects of Sweetener Consumption on Risk Factors for Heart Disease","Sweetheart","Inclusion Criteria:\n\n* Presence of prediabetes (HbA1c 5.7-6.4% or glucose after oral glucose tolerance test 140 to 199 mg\u002FdL)\n* Written informed consent available\n\nExclusion Criteria:\n\n* Inability to communicate sufficiently in the required language\n* Dementia or other significantly cognitively impairing condition\n* Current pregnancy or breastfeeding\n* Other severe internal, neurological, or psychiatric condition\n* History of gout\n* History of gallstones \u002F diagnosis of cholelithiasis","75 Years",{"count":253,"type":22},80,[25],"The aim of this prospective interventional study is to investigate the metabolic effects of consuming artificial and natural sweeteners in persons with prediabetes. Prediabetes is a condition characterized by blood sugar levels that are elevated above normal but not yet meeting the criteria for type 2 diabetes. This condition markedly increases the risk of progressing to type 2 diabetes, which in turn can lead to complications including cardiovascular diseases.\n\nArtificial sweeteners such as saccharin and sucralose, as well as natural sugar substitutes like erythritol, are increasingly used as alternatives to sugar and are recommended for individuals at cardiometabolic risk - including overweight individuals, patients with prediabetes, or diabetics - to help reduce caloric intake. Recent literature has reported possible negative associations between artificial sweeteners and blood sugar regulation in healthy subjects (1). Additionally, effects on various blood cells have been observed. For example, erythritol has been shown to alter platelet function leading to increased reactivity in healthy study participants following consumption (2).\n\nHowever, the impact of alternative sweeteners on metabolic processes and their effects on blood coagulation in patients with prediabetes-a population at increased risk-has not been systematically studied. In this planned interventional study, 80 patients meeting laboratory criteria for prediabetes will be randomly assigned to one of four groups, each receiving a different intervention for two weeks: saccharin, sucralose, erythritol, or a control group receiving water. The doses reflect the acceptable daily intake or known doses that are considered safe.\n\nAfter enrollment, participants will visit the study center 2 times: before starting the intervention and after completing the intervention. During these visits, biological samples such as blood, urine, and stool will be collected to study metabolism, gut bacteria, immune and blood cell function. Tests will include an oral glucose tolerance test, coagulation tests, and additional blood analyses. Additionally, participants will wear a glucose monitor to track blood sugar fluctuations during the intervention.\n\nThe investigators hypothesize that consumption of alternative sweeteners negatively affects blood sugar regulation and insulin sensitivity in patients with prediabetes. Furthermore, this study will explore how the candidate sweeteners influence the gut microbiome, blood cells and other metabolic factors in this population.",[257,258,259,260,261,262,263,264,30,28,265],"Prediabetic State","Metabolic Syndrome","Insulin Resistance","Thrombosis","Hypercoagulable State","Cardiovascular (CV) Risk","Cardiovascular Risk Factors","Cardiovascular Diseases (CVD)","Sweeteners","2026-01-22",{"date":268,"type":38},"2026-01-29",{"date":270,"type":22},"2026-01-05",{"date":272,"type":22},"2026-11-01",{"name":274,"class":45},"Charite University, Berlin, Germany",{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":115,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":106},"100567680","chronic-dorzagliatin-on-insulin-and-incretin-function-in-intermediate-hyperglycemia-and-type-2-diabetes-100567680","NCT06671340","Chronic Dorzagliatin on Insulin and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes","Effects of Repeated Dose of Dorzagliatin on Insulin Secretion, Glucagon Release and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes","Inclusion Criteria:\n\n1. Individuals aged ≥ 18 years but \\\u003C 70 years\n2. Male or female\n3. Body mass index of over 18 kg\u002Fm2 and \\\u003C 35 kg\u002Fm2\n\nAdditional inclusion criteria for IH group\n\n* Fasting plasma glucose \\\u003C7.0 mmol\u002FL and HbA1c \\\u003C 6.5%\n* 1 hour plasma glucose ≥8.6 and \\\u003C11.6 mmol\u002FL on 75g oral glucose tolerance test (OGTT)\n* No use of glucose lowering drugs in past 6 months\n\nAdditional inclusion criteria for T2D group\n\n* HbA1c 6.5 to 10% at screening\n* On diet control, or stable dose of oral glucose lowering drugs metformin for at least 8 weeks\n\nExclusion Criteria:\n\n* 1\\. Subjects who do not agree to participate in this study. 2. Country of birth is unknown. 3. Body weight less than 45kg. 4. Acute phase of cerebrovascular and cardiovascular diseases (within 6 months of recruitment).\n\n  5\\. Subjects with severe renal dysfunction as defined by eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2 or patients receiving renal dialysis (such as haemodialysis or continuous ambulatory peritoneal dialysis).\n\n  6\\. Severe hepatic dysfunction as defined by aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\> 3 times upper limit of normal.\n\n  7\\. Severe cardiovascular disease, history of stroke, heart failure (NYHA III or IV) or history of myocardial infarction within last 12 months.\n\n  8\\. History of drug abuse or excessive alcohol intake based on investigator judgment.\n\n  9\\. Dehydration, diarrhoea or vomiting at the time of recruitment. 10. Subjects with severe infection, in perioperative period or with serious injury at the time of recruitment.\n\n  11\\. Subjects with anaemia (Haemoglobin \\\u003C9.0mg\u002FdL). 12. Pregnant or lactating or intending to become pregnant within 30 days after last dose of study drug.\n\n  13\\. Participation in a clinical trial with investigational product within 30 days before enrolment.\n\n  14\\. Donation or loss of blood (excluding the volume of blood that will be drawn during screening procedures) as follows: ≥300 mL of blood within 30 days prior to study drug administration.\n\n  15\\. Subjects judged unsuitable for the study based on investigator judgment. 16. Use of strong or moderate CYP3A4 inhibitors or inducers and cannot be discontinued.\n\n  17\\. Unwilling or unable to follow protocol requirements.",{"count":283,"type":22},30,[25],"A total of 30 subjects will be recruited 15 with intermediate hyperglycemia and 15 in the tyep 2 diabetes group respectively. Eligible participants will undergo hyperglycemic-clamp\u002Foral glucose tolerance at baseline and after 4 weeks of dorzagliatin treatment.",[287,28],"Diabetes Mellitus",[289,290,291],"clamp","diabetes","glucokinase activator","2025-03-01",{"date":294,"type":38},"2025-03-04",{"date":296,"type":22},"2025-04-02",{"date":298,"type":22},"2026-01-31",{"name":300,"class":45},"Elaine Chow",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":251,"enrollmentInfo":307,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":106},"100568524","phase-4-heterogeneity-of-diabetes-integrated-muli-omics-to-identify-physiologic-subphenotypes-and-evaluate-targeted-prevention-100568524","NCT06682351","Heterogeneity of Diabetes: Integrated Muli-Omics to Identify Physiologic Subphenotypes and Evaluate Targeted Prevention","Inclusion Criteria:\n\n* BMI ≥23 (≥22 in Asians) kg\u002Fm2 but \\\u003C 45 kg\u002Fm2\n* HbA1c 5.7-8.0% while not on antihyperglycemic medications\n\nExclusion Criteria:\n\n* Recent (\\\u003C6mos) CVD event\n* active malignancy, kidney\u002Fliver disease pregnancy\u002Flactation, chronic inflammatory disease, eating disorder, bariatric surgery\n* history of acute pancreatitis\n* family or personal history of medullary thyroid cancer\n* current use of antihyperglycemic, diabetogenic, or weight loss medications (washout allowed if approved by primary physician)\n* heavy alcohol use\n* hct \\\u003C30, creatinine \\> 1.4, ALT\\> 3x ULN\n* physical activity \\>2 hours\u002Fday\n* inability to come to Stanford CTRU for metabolic testing",{"count":308,"type":22},200,[310],"PHASE4","The study team will invite participants with prediabetes or mild diabetes (HbA1c 5.7-7.0) to join a 5-year research study that will define subphenotypes of type 2 diabetes based on underlying physiology (eg insulin resistance, beta-cell dysfunction, incretin defect, liver insulin resistance) and then test the hypothesis that response to three first-line treatments will vary according to metabolic subphenotype. Variables of interest include glucose, cardiovascular risk markers, and weight. Treatments include Mediterranean diet, metformin, and a GLP-1 agonist. Participants will go through an initial screening, followed by three treatment periods, each lasting 4 months with 3 month washout in-between treatment periods. This study will help us understand how personalized treatments can help control blood glucose, reduce cardiovascular risk, and manage weight. While there may be minor side effects-like slight discomfort from blood tests, gastrointestinal symptoms from some of the medications, and small radiation exposure from DXA body scans-the treatments offered in this study have all been well studied and are known to lower risk for diabetes and cardiovascular disease",[28],"2024-11-07",{"date":315,"type":38},"2024-11-12",{"date":317,"type":22},"2024-11",{"date":319,"type":22},"2027-12",{"name":321,"class":45},"Stanford University"]