[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"impaired-glucose-tolerance-prediabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:impaired-glucose-tolerance-prediabetes":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,80,120,157],{"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":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100641577","phase-4-mazdutide-for-adults-with-prediabetes-a-randomized-double-blind-placebo-controlled-trial-dream-pre-100641577",false,"NCT07654062","Mazdutide for Adults With Prediabetes: A Randomized, Double-Blind, Placebo-Controlled Trial (DREAM-PRE)","Efficacy and Safety of Mazdutide in Adults With Prediabetes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (DREAM-PRE)","DREAM-PRE","Inclusion Criteria:\n\n1. Voluntarily signed written informed consent prior to any study procedures\n2. Age 18 to 75 years (inclusive) at the time of signing informed consent; male or female\n3. Prediabetes confirmed by central laboratory at screening, meeting at least one of the following criteria per Chinese Diabetes Society (CDS) standards, and not meeting diagnostic criteria for diabetes:\n\n   * Impaired Glucose Tolerance (IGT): 75g OGTT 2-hour plasma glucose\n\n     * 7.8 mmol\u002FL and \\\u003C11.1 mmol\u002FL\n   * Impaired Fasting Glucose (IFG): fasting plasma glucose ≥6.1 mmol\u002FL and \\\u003C7.0 mmol\u002FL\n   * Elevated HbA1c: 5.7% ≤ HbA1c \\\u003C 6.5% (39-48 mmol\u002Fmol)\n4. BMI ≥22.0 kg\u002Fm² at screening\n5. Self-reported body weight change \\\u003C10% within 3 months prior to screening; not currently participating in any organized weight-loss program\n6. Able to understand study requirements, complete all planned visits and examinations, self-administer once-weekly subcutaneous injections, and use the study app for daily monitoring\n\nExclusion Criteria:\n\n1. Confirmed diabetes at screening (FPG ≥7.0 mmol\u002FL, OGTT 2h-PG ≥11.1 mmol\u002FL, or HbA1c ≥6.5%); or prior confirmed diagnosis of type 1 diabetes, type 2 diabetes, or other specific types of diabetes. Prior gestational diabetes in whom blood glucose has returned to prediabetes levels after delivery is NOT grounds for exclusion.\n2. Continuous use of any antidiabetic medication for more than 7 days within 3 months prior to screening, including: biguanides (metformin), alpha-glucosidase inhibitors (acarbose, voglibose, miglitol), sulfonylureas (glimepiride, gliclazide, glipizide, glibenclamide), glinides (repaglinide, nateglinide), thiazolidinediones (pioglitazone, rosiglitazone), DPP-4 inhibitors (sitagliptin, saxagliptin, vildagliptin, linagliptin, alogliptin), SGLT2 inhibitors (dapagliflozin, empagliflozin, canagliflozin, ertugliflozin), insulin (any formulation), or traditional Chinese medicine with confirmed glucose-lowering indication.\n3. Use of any of the following within 6 months prior to screening (regardless of duration): GLP-1 receptor agonists (semaglutide, liraglutide, dulaglutide, exenatide, lixisenatide, benaglutide, etc.), GIP\u002FGLP-1 dual agonists (tirzepatide, etc.), any dual or triple agonist containing GLP-1R and\u002For GCGR components (including mazdutide), or any GLP-1 class investigational drug in clinical development.\n4. Use of any prescription weight-loss medication within 3 months prior to screening (regardless of duration), including orlistat, naltrexone\u002Fbupropion combination, phentermine\u002Ftopiramate combination, or any weight-loss drug approved in China or in clinical development. Over-the-counter dietary supplements are not excluded but must be recorded.\n5. Spontaneous body weight change ≥10% within 3 months prior to screening (based on self-report and\u002For available medical records), or currently participating in any organized weight-loss program (including commercial weight-loss plans or weight-loss interventions in other clinical trials).\n6. Prior bariatric or metabolic surgery including Roux-en-Y gastric bypass, sleeve gastrectomy, adjustable gastric banding, biliopancreatic diversion, intragastric balloon placement, or other bariatric surgery.\n7. Prior history of acute pancreatitis (confirmed by imaging or surgery) or chronic pancreatitis; or serum amylase \\>3× ULN or serum lipase \\>3× ULN at screening.\n8. Personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2); first-degree family history of MTC or MEN2; or serum calcitonin ≥50 ng\u002FL at screening.\n9. Any of the following within 6 months prior to screening: acute myocardial infarction (STEMI or NSTEMI), ischemic or hemorrhagic stroke, transient ischemic attack (TIA), coronary revascularization (PCI or CABG), or hospitalization for unstable angina.\n10. NYHA Class III or IV heart failure. (NYHA Class I and II are not grounds for exclusion.)\n11. Clinically significant arrhythmia on 12-lead ECG at screening, including:\n\n    Mobitz Type II or third-degree atrioventricular block, sustained ventricular tachycardia (≥30 seconds or requiring cardioversion), QTcF \\>500 ms, or resting heart rate \\\u003C50 bpm (in subjects not using beta-blockers or calcium channel blockers).\n12. Uncontrolled hypertension: confirmed mean systolic blood pressure ≥180 mmHg and\u002For mean diastolic blood pressure ≥110 mmHg on repeated measurements at screening despite antihypertensive therapy. Subjects with controlled blood pressure on a stable antihypertensive regimen (stable for ≥4 weeks prior to screening) are allowed to enroll.\n13. ALT \\>3× ULN, AST \\>3× ULN, or total bilirubin \\>2× ULN at screening (except confirmed Gilbert's syndrome with normal direct bilirubin).\n14. eGFR (CKD-EPI) \\\u003C45 mL\u002Fmin\u002F1.73 m² at screening. Subjects with eGFR 45-60 mL\u002Fmin\u002F1.73 m² may enroll with enhanced renal function monitoring.\n15. Any of the following gastrointestinal conditions: known gastroparesis (confirmed by gastric emptying study or clinical diagnosis), inflammatory bowel disease (Crohn's disease or ulcerative colitis, active or remission), short bowel syndrome, prior gastrointestinal surgery likely to affect drug absorption (excluding simple appendectomy and laparoscopic cholecystectomy), or other serious gastrointestinal disease likely to significantly affect drug tolerability or absorption.\n16. Diagnosis or active treatment of any malignancy within 5 years prior to screening.\n17. Positive urine pregnancy test at screening, currently breastfeeding, or planning pregnancy during the 48-week study period.\n18. Known allergy to mazdutide or any excipient in its formulation; or prior serious allergic reaction to any GLP-1 class drug (defined as angioedema, anaphylactic shock, or allergic reaction requiring hospitalization).\n19. Participation in any other interventional clinical trial within 3 months prior to screening (excluding purely observational or epidemiological studies not involving investigational drugs or devices), or currently enrolled in any other clinical trial.\n20. Currently on long-term systemic corticosteroids (expected continuous use \\>14 days, oral or intravenous); or currently using drugs known to significantly affect body weight or glucose metabolism that cannot be discontinued or substituted, including antipsychotics (olanzapine, clozapine, quetiapine, etc.), valproate sodium, or lithium.\n21. History of alcohol abuse within 1 year prior to screening, defined as daily consumption \\>3 standard drink units (men) or \\>2 standard drink units (women) sustained for \\>3 months (1 standard drink unit ≈ 10g pure alcohol).","ALL","18 Years","75 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Prediabetes affects millions of adults worldwide and carries a high risk of progression to type 2 diabetes. Mazdutide is a once-weekly injectable drug that activates both GLP-1 and glucagon receptors, lowering blood sugar and body weight simultaneously.\n\nThis study (DREAM-PRE) tests whether mazdutide can help adults with prediabetes return to normal blood sugar levels. Approximately 150 adults aged 18-75 years with prediabetes and BMI ≥22 kg\u002Fm² will be randomly assigned in equal numbers to one of three groups: mazdutide 4 mg once weekly, mazdutide 6 mg once weekly, or placebo once weekly. All participants also receive standardized diet and exercise guidance throughout the study.\n\nTreatment lasts 24 weeks, followed by 24 weeks of off-drug follow-up to see whether any benefits are maintained. The main question is: what proportion of participants achieve completely normal blood sugar (normal HbA1c, fasting glucose, AND glucose tolerance test) after 24 weeks of treatment? The study is conducted at approximately 10 hospitals across China.",[28,29,30],"Prediabetes","Impaired Fasting Glucose","Impaired Glucose Tolerance (Prediabetes)",[32,33,34,28,35,36,37,38,39],"Mazdutide","IBI362","GLP-1R\u002FGCGR dual agonist","Diabetes prevention","Normal glucose regulation","Beta-cell function","Insulin resistance","Weight loss","NOT_YET_RECRUITING","2026-06-13",{"date":43,"type":44},"2026-06-17","ACTUAL",{"date":46,"type":22},"2026-07",{"date":48,"type":22},"2029-07",{"name":50,"class":51},"Shandong Provincial Hospital","OTHER_GOV",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":52},"100639487","growth-hormone-resistance-of-beta-cells-100639487","NCT07581860","Growth Hormone Resistance of Beta-cells","Growth Hormone Resistance of Beta-cells in People With Impaired Fasting Glucose vs Impaired Glucose Tolerance","GHRB-C","Inclusion Criteria:\n\n* body mass index \\>18.5kg\u002Fm2 and \\\u003C45.9kg\u002Fm2\n* impaired fasting glucose \\>\u002F= 100mg\u002FdL, \\\u003C\u002F= 126mg\u002FdL or impaired glucose tolerance on 75g oral glucose tolerance test (blood glucose 140 to 199mg\u002FdL at two-hours)\n\nExclusion Criteria:\n\n* pregnant, planning to become pregnant during the study, or breastfeeding\n* current diagnosis or history of type 1 or type 2 diabetes\n* use of medications that can impact the study outcomes (e.g., GLP-1 receptor agonists)\n* history of bariatric surgery\n* known, uncontrolled hypothyroidism\n* history of intracranial hypertension, including papilledema, or a condition that increases the risk of developing intracranial hypertension, such as Turner Syndrome, Prader-Willi Syndrome, or renal impairment\n* current cancer or cancer that has been in remission less than 5 years\n* first degree relative with type 1 diabetes\n* evidence of anemia or significant end organ dysfunction (e.g., liver, kidney, heart disease)\n* alcohol use disorder, use of controlled substances, or smoking \\>2 cigarettes per day\n* greater than 3% weight loss within three months of screening or engaged in regular (\\>\u002F= 3 days per week), continuous moderate- or high-intensity exercise of \\>\u002F= 30 min duration\n* mentally disabled persons, prisoners, and persons with inability to grant voluntary informed consent","59 Years",{"count":63,"type":22},10,"OBSERVATIONAL","The purpose of the research study is to better understand how beta-cells (cells in the pancreas that make insulin and help regulate blood sugar) respond to growth hormone in people with impaired fasting glucose or impaired glucose tolerance at the University of Missouri. The aim of the study is to advance understanding of how growth hormone affects beta-cells and risk factors for developing type 2 diabetes.",[67,68,69,30],"Healthy","Obesity & Overweight","Impaired Fasting Glucose (IFG)","2026-05-05",{"date":72,"type":44},"2026-05-12",{"date":74,"type":22},"2026-08-01",{"date":76,"type":22},"2030-09-01",{"name":78,"class":79},"University of Missouri-Columbia","OTHER",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100631644","standardized-italian-network-enrolling-individuals-with-islet-autoantibodies-100631644","NCT07503366","Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies","Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies (SIRENA)","SIRENA","Inclusion Criteria:\n\n* Individuals of any age who test positive for at least one islet autoantibody.\n* Absence of clinical symptoms of diabetes.\n* Do not meet ADA diagnostic criteria for diabetes (no overt hyperglycemia).\n* Ability to comply with follow-up procedures according to clinical practice.\n* Written informed consent obtained from the participant or, for minors, from a parent or legal guardian.\n\nExclusion Criteria:\n\n* Prior diagnosis of type 1 or type 2 diabetes.\n* Fasting plasma glucose ≥126 mg\u002FdL, HbA1c ≥6.5%, or OGTT 2-hour glucose ≥200 mg\u002FdL.\n* Presence of symptoms suggestive of diabetes (e.g., polyuria, polydipsia, unexplained weight loss, fatigue, visual disturbances, acetone breath, Kussmaul respiration).\n* Any medical or psychological condition judged by the investigator to interfere with study participation or data reliability.\n* Inability or unwillingness to provide informed consent.",{"count":89,"type":22},300,"This project characterizes the longitudinal progression of children and adults who have tested positive for one or more islet cell autoantibodies across the early stages of type 1 diabetes (T1D). Despite advances in screening, limited evidence exists on how clinical, metabolic, and immunological markers evolve over time and predict progression to symptomatic disease. Using a screened cohort, participants are followed for up to 10 years with repeated standardized assessments. The study evaluates whether population-based screening can reduce diabetic ketoacidosis (DKA) at diagnosis and identify early predictors of progression to clinical T1D. Results are expected to improve risk stratification, inform surveillance strategies, and guide the timing of preventive interventions, with implications for clinical practice and health policy.",[92,93,94,30],"Type 1 Diabetes (T1D)","Autoantibodies","Hyperglycemia",[96,93,97,98,94,99,100,101,102,103,104,105,106,107,108,109],"Diabetes Mellitus, Type 1","Islets of Langerhans","Autoimmune Diseases","Impaired Glucose Tolerance","C-Peptide","Oral Glucose Tolerance Test","Continuous Glucose Monitoring","Psychological Stress","Early Diagnosis","Disease Progression","Presymptomatic Type 1 Diabetes","Type 1 Diabetes Stage 1","Type 1 Diabetes Stage 2","Type 1 Diabetes Stage 3","2026-04-02",{"date":112,"type":44},"2026-04-08",{"date":114,"type":22},"2026-05",{"date":116,"type":22},"2036-04",{"name":118,"class":79},"Società Italiana di Endocrinologia e Diabetologia Pediatrica",24,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":23,"phases":131,"briefSummary":133,"conditions":134,"keywords":140,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":52},"100598614","probiotic-impact-on-cognitive-performance-and-metabolic-outcomes-in-overweight-young-adults-with-impaired-glucose-regulation-100598614","NCT07073781","Probiotic Impact on Cognitive Performance, and Metabolic Outcomes in Overweight Young Adults With Impaired Glucose Regulation","A Double-blind Placebo-controlled Exploratory Trial to Assess the Impact of Daily Lab4P Probiotic Supplementation on Cognitive Performance and Metabolic Regulation in Overweight Young Adults With Impaired Glucose Regulation","ProCog","Inclusion Criteria\n\n* Aged 18-40 years\n* Body Mass Index (BMI) between 25.0 and 29.9 kg\u002Fm² (classified as overweight)\n* In good general health (self-reported)\n* Normal self-reported sleep patterns, with no history of diagnosed sleep disorders\n* Willing and able to provide informed consent\n* Able to comply with study procedures, including fasting and oral glucose tolerance testing\n\nExclusion Criteria:\n\n* Diagnosed diabetes (any type).\n* Diagnosed sleep disorders.\n* Fasting glucose \\>6.9 mmol\u002FL during screening.\n* History of bariatric surgery (e.g., gastric bypass, sleeve gastrectomy).\n* Major surgery, significant illness, trauma, infection, or myocardial infarction within the past 6 weeks.\n* Current use of medications affecting glucose metabolism or probiotics\n* Pregnancy or actively trying to conceive\n* Night shift work within the past month","40 Years",{"count":130,"type":22},70,[132],"NA","This 12-week, double-blind, placebo-controlled trial will examine whether daily supplementation with the Lab4P probiotic can improve cognitive performance and metabolic health in overweight adults aged 18 to 40 with impaired glucose tolerance, a preclinical condition where blood glucose regulation is mildly disrupted. Seventy participants will be randomly assigned to receive either Lab4P or a placebo. The study will assess changes in memory, executive function, and processing speed, along with blood glucose control, cardiovascular function, cholesterol levels, body composition, and markers of inflammation. The study will also analyse changes in the gut microbiome and evaluate the safety and tolerability of the probiotic.",[135,30,136,137,138,139],"Impaired Glucose Regulation","Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)","Overweight (BMI > 25)","Cognitive Dysfunction","Neurovascular Coupling Mechanism and Cognitive Function",[141,142,143,144,145,146],"Probiotic supplementation","Psychobiotic","Cognitive performance","Metabolic function","Impaired glucose tolerance","Gut-brain axis","RECRUITING","2026-03-25",{"date":150,"type":44},"2026-03-31",{"date":152,"type":44},"2025-08-15",{"date":154,"type":22},"2026-08-20",{"name":156,"class":79},"Leeds Beckett University",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":164,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":23,"phases":168,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":4},"100613224","effect-of-a-food-supplement-on-glycemic-parameters-in-patients-with-impaired-glucose-metabolism-100613224","NCT07263802","Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism","Evaluation of the Efficacy of GlycoDual on Postprandial Glycemic Control and Insulin Sensitivity in Subjects With Impaired Glucose Metabolism: a Randomized, Controlled, Double-blind Study","Inclusion Criteria:\n\n* body mass index (BMI) 25.0-29.9 kg\u002Fm2\n* FPG levels between 100 and 125 mg\u002Fdl \\[IFG diagnosed after Oral Glucose Tolerance Test (OGTT)\\]\n* HOMA-IR \\> 2.5\n* subjects able to understand the informed consent and sign it before enrollment in the study\n\nExclusion Criteria:\n\n* personal history of cardiovascular disease or equivalent risk factors\n* obesity (BMI ≥ 30 kg\u002Fm²)\n* taking hypoglycemic drugs or supplements that affect glycemic metabolism\n* diabetes mellitus or IGT\n* pregnancy or breastfeeding\n* known thyroid, liver, kidney or muscle diseases\n* any medical or surgical condition that makes patient compliance with the study protocol complex or inconsistent\n* any known allergy or hypersensitivity to one or more components of the food supplement","35 Years","70 Years",{"count":167,"type":22},90,[132],"The primary objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.\n\nSecondary objectives are to estimate:\n\n* the change of insulin sensitivity (HOMA-IR)\n* the change of uricemia after 90 days of supplementation compared to placebo.\n\nSafety objectives: Collection of the adverse events not related, related or possibly related to the study products.",[69,30],[172,173,174],"dysglycemia","Gymnema sylvestre","Zinc bisglycinate","2025-11-23",{"date":177,"type":44},"2025-12-04",{"date":179,"type":22},"2025-12-01",{"date":181,"type":22},"2026-02-28",{"name":183,"class":79},"Fondazione IRCCS Policlinico San Matteo di Pavia"]