[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-2-diabetes-mellitus-t2dm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-2-diabetes-mellitus-t2dm":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,116,0,25,[9,54,89,116,150,173,203,242,269,293,337,368,394,417,445,478,500,527,549,574,592,619,643,668,693],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100652941","ceeec-ii-a-12-week-physical-and-cognitive-enrichment-extension-study-in-older-stroke-survivors-with-multimorbidity-100652941",false,"NCT07778771","CEEEC-II: A 12-Week Physical and Cognitive Enrichment Extension Study in Older Stroke Survivors With Multimorbidity","A 12-Week, Multicenter, Open-Label, 2×2 Factorial, Cluster-Assigned Extension Study of Upgraded Physical and AI-Enabled Large-Screen Cognitive Enrichment for Older Stroke Survivors With Multimorbidity in Kunshan, China","CEEEC-II","Inclusion Criteria:\n\n* Completed the endpoint assessment of the preceding CEEEC Phase I trial (NCT06975501) and remains under management at a participating community health service station in Kunshan.\n* Age 60 years or older.\n* Hospital-confirmed ischemic or hemorrhagic stroke in a stable stage, with no new or worsening neurological deficit within the previous 3 months.\n* Registered hypertension and\u002For type 2 diabetes mellitus; other comorbid conditions are permitted.\n* Willing and able to participate in the 12-week community-based extension program and complete baseline and endpoint assessments.\n* Able to travel to the community site independently or with a cane or walker; not dependent on a wheelchair for attendance.\n* Short Physical Performance Battery total score \\>=3, or able to maintain a supported side-by-side standing position for 10 seconds when the total score is \\\u003C3.\n* Able to communicate in Mandarin Chinese or the Kunshan dialect and able to recognize Arabic numerals.\n* Corrected vision sufficient to identify large characters at approximately 40 cm and at least one upper limb able to complete touchscreen selection.\n* Resides in the participating community and has no plan to move away during the study period.\n* Provides written informed consent specifically for CEEEC-II.\n\nExclusion Criteria:\n\n* Life-threatening disease or another condition associated with an expected survival of less than 6 months.\n* A new stroke, transient ischemic attack, acute coronary event, or hospitalization for decompensated heart failure within the previous 3 months.\n* Uncontrolled resting blood pressure (systolic \\>=180 mmHg or diastolic \\>=110 mmHg after repeated measurement) until clinically reassessed and controlled.\n* Extreme glycemic instability, including fasting blood glucose \\>16.7 mmol\u002FL or severe hypoglycemia requiring assistance within the previous month, until clinically reassessed.\n* An absolute contraindication to unsupervised community exercise or another medical condition judged by the study clinician to make participation unsafe.\n* Unable to walk to the community site even with a cane or walker, or dependent on a wheelchair for attendance.\n* A severe musculoskeletal, neurological, visual, hearing, cognitive, psychiatric, or communication impairment that prevents safe participation or valid completion of study procedures.\n* Unable to recognize Arabic numerals or unable to complete touchscreen selection with either upper limb.\n* Current participation in another structured physical, cognitive, or nutrition intervention study that may contaminate the assigned intervention.\n* Any other reason documented by the study clinician as making the individual unsuitable for participation.","ALL","60 Years",{"count":21,"type":22},365,"ESTIMATED","INTERVENTIONAL",[25],"NA","CEEEC-II is a 12-week, community-based, prospective extension study conducted in 32 community health service stations in Kunshan, China. It will invite older stroke survivors with hypertension and\u002For type 2 diabetes who participated in the preceding CEEEC Phase I trial (NCT06975501) to provide new informed consent and complete Phase II eligibility and baseline assessments. Participants will remain in the physical enrichment, cognitive enrichment, combined enrichment, or usual-care arm assigned to their community cluster in Phase I; no new randomization will occur in CEEEC-II. The upgraded program includes eight physician-led Vitality Camp sessions and four volunteer-led reinforcement activities. The physical component integrates aerobic, resistance, balance, flexibility, Baduanjin, and nutrition education. The cognitive component integrates health education with age-adapted games delivered through an AI-enabled interactive large screen. The primary objective is to evaluate the marginal effect of the cognitive enrichment factor on intrinsic capacity at 12 weeks.",[28,29,30,31],"Stroke","Hypertension","Type 2 Diabetes Mellitus (T2DM)","Multimorbidity",[33,34,35,36,37,38,39,40],"Intrinsic Capacity","Older Adults","Community Health Services","Environmental Enrichment","Cognitive Training","Physical Exercise","Multicomponent Intervention","Cluster-Assigned Extension Study","NOT_YET_RECRUITING","2026-08-18",{"date":44,"type":45},"2026-08-21","ACTUAL",{"date":47,"type":22},"2026-08-31",{"date":49,"type":22},"2027-01-03",{"name":51,"class":52},"Duke Kunshan University","OTHER",1,{"id":55,"slug":56,"hasResults":12,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":62,"targetDuration":64,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":53},"100652212","cardioprotective-effects-of-sglt2-inhibitors-and-glp-1-receptor-agonists-in-korean-patients-with-type-2-diabetes-100652212","NCT07770737","Cardioprotective Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Korean Patients With Type 2 Diabetes","Evaluation of Cardioprotective Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists in Korean Patients With Type 2 Diabetes: A Multicenter CDM-Based Retrospective Cohort Study With Prospective AI-ECG Validation","Phase 1: Retrospective Cohorts\n\nInclusion Criteria:\n\n* Adults aged 19 years or older.\n* Diagnosis of type 2 diabetes mellitus.\n* New initiation of a study medication, including an SGLT2 inhibitor, a GLP-1 receptor agonist, or another eligible glucose-lowering medication.\n* At least 180 days of observable data before the index date, defined as the date of the first eligible prescription.\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus or secondary diabetes mellitus.\n* Use of a medication from the same drug class within 90 days before the index date.\n* Pregnancy recorded during the relevant study period.\n* A history of the outcome being evaluated during the baseline period, applied separately for each outcome analysis.\n\nPhase 2: Prospective SGLT2 Inhibitor Validation Cohort\n\nInclusion Criteria:\n\n* Adults aged 50 years or older receiving outpatient care at Dongtan Sacred Heart Hospital.\n* Diagnosis of type 2 diabetes mellitus.\n* No current or previous signs or symptoms of heart failure and New York Heart Association functional class I.\n* At least one of the following high-risk characteristics: diabetes duration of 5 years or longer, hypertension, body mass index of 25 kg\u002Fm² or higher, urinary albumin-to-creatinine ratio of 30 mg\u002Fg or higher, estimated glomerular filtration rate below 60 mL\u002Fmin\u002F1.73 m², or diabetic microvascular complications.\n* No previous treatment with an SGLT2 inhibitor and scheduled to initiate an SGLT2 inhibitor based on the treating physician's clinical judgment.\n* Ability and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Current or previous diagnosis of heart failure, hospitalization for heart failure, clinically suspected signs or symptoms of heart failure, or screening left ventricular ejection fraction below 50%.\n* Moderate or severe valvular heart disease, known hypertrophic, dilated, or infiltrative cardiomyopathy, complex congenital heart disease, or clinically significant pericardial disease.\n* Acute coronary syndrome, coronary revascularization, or stroke within 3 months before enrollment.\n* Presence of a pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device.\n* Atrial fibrillation, sustained tachycardia, frequent premature contractions, or another arrhythmia that prevents reliable comparison of ECG or global longitudinal strain measurements.\n* Type 1 diabetes mellitus, secondary diabetes mellitus, diabetic ketoacidosis within the previous year, or another clinical condition making SGLT2 inhibitor treatment inappropriate.\n* Estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m² or dialysis.\n* Echocardiographic image quality insufficient for reliable 3-view global longitudinal strain or stage B heart failure assessment.\n* Pregnancy or breastfeeding.\n* Unwillingness to undergo study assessments or inability to complete the 6-month follow-up.","19 Years",{"count":63,"type":22},100,"6 Months","OBSERVATIONAL","This observational study will evaluate the cardiovascular effects of sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists (GLP-1 receptor agonists) in Korean adults with type 2 diabetes.\n\nThe study consists of two phases. Phase 1 will use de-identified electronic health record data from multiple Korean hospitals organized in a common data model. Cardiovascular outcomes, including myocardial infarction, ischemic stroke, and hospitalization for heart failure, will be compared among patients who started an SGLT2 inhibitor or a GLP-1 receptor agonist. Fractures, metabolic changes, and real-world medication use will also be evaluated.\n\nPhase 2 will prospectively enroll approximately 100 adults with type 2 diabetes who are starting an SGLT2 inhibitor as part of routine clinical care at Dongtan Sacred Heart Hospital. Participants will undergo electrocardiography, AI-based ECG analysis, echocardiography, blood and urine tests, and body composition assessment at baseline. Approximately 50 participants with stage B heart failure, defined as structural or functional heart abnormalities without heart failure symptoms, will undergo the same assessments after 6 months. The primary outcome of Phase 2 is the change in echocardiographic global longitudinal strain from baseline to 6 months. The study will also examine whether changes detected by AI-based ECG are associated with changes in echocardiographic measures of cardiac function.\n\nThe study does not assign medications or alter routine treatment. All treatment decisions are made by the participants' treating physicians.",[30,68,69],"Cardiovascular Diseases","Stage B Heart Failure",[71,72,73,74,75,76,77,69,78,79,80],"SGLT2 Inhibitor","GLP-1 Receptor Agonist","Cardiovascular Protection","Artificial Intelligence Electrocardiography","AI-ECG","Global Longitudinal Strain","Diabetic Cardiomyopathy","Pre-Heart Failure","OMOP Common Data Model","Real-World Data","2026-08-13",{"date":42,"type":45},{"date":84,"type":22},"2026-09",{"date":86,"type":22},"2027-12-31",{"name":88,"class":52},"Dongtan Sacred Heart Hospital",{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":18,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":99,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100644599","phase-3-a-study-to-evaluate-the-effects-of-enicepatide-in-participants-with-obesity-or-overweight-with-or-without-type-2-diabetes-100644599","NCT07670416","A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Body mass index (BMI) ≥24.0 kilograms per meter squared (kg\u002Fm\\^2) for participants with type 2 diabetes mellitus (T2DM)\n* BMI ≥28.0 kg\u002Fm\\^2 or BMI ≥24.0 and \\\u003C28.0 kg\u002Fm\\^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM\n* Agreement to adhere to the contraception requirements\n\nExclusion Criteria:\n\n* History of Type 1 diabetes mellitus (T1DM)\n* Obesity induced by other endocrinologic disorders\n* Any planned major medical procedure or surgery during the study\n* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder\n* Any lifetime history of suicide attempt\n* History of any hematologic conditions that may interfere with HbA1c measurement\n* History of acute or chronic pancreatitis or clinically signiﬁcant gallbladder disease\n* Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization\n* Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer\n* Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1\u002FGIP RAs","18 Years",{"count":98,"type":22},300,[100],"PHASE3","The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)\u002Fglucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.",[103,104,30],"Obesity","Overweight","RECRUITING","2026-08-12",{"date":81,"type":45},{"date":109,"type":45},"2026-07-03",{"date":111,"type":22},"2028-03-15",{"name":113,"class":114},"Hoffmann-La Roche","INDUSTRY",18,{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":12,"sex":18,"minAge":124,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":136,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":53},"100628559","integrating-new-skills-into-diabetes-education-with-cgm-100628559","NCT07463209","Integrating New Skills Into Diabetes Education With CGM","Integrating New Skills Into Diabetes Education With CGM (INSIDE-CGM): An Individualized CGM Integration Program for Older Adults With Diabetes","INSIDE-CGM","Participant Inclusion Criteria:\n\n* Adults 65 years and older at time of consent\n* Actively receiving care at a UNC Health or UNC Physicians Network clinic (defined as 2 or more visits in primary care, family medicine, internal medicine, geriatrics, or endocrinology clinics within the past 365 days). Locality for care is defined as receiving care within a 90-mile radius of UNC Main Hospital on Manning Drive in Chapel Hill, NC.\n* Using any insulin at least once daily\n* No continuous glucose monitor (CGM) use within the previous 365 days\n* Willing to use a smartphone to access glucose readings using CGM phone app\n* Fluent in English\n\nParticipant Exclusion Criteria:\n\n* Clinical diagnosis of dementia, assessed through chart review and self-report on screening visit (cognitive impairment that is mild and not considered sufficient for diagnosis of dementia is acceptable)\n* Currently receiving dialysis, assessed through chart review and self-report on screening visit\n* Extreme visual or hearing impairment that would impair ability to use real-time CGM or attend and participate in an in-person or virtual group intervention session, assessed at screening visit\n* The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with life expectancy of \\\u003C1 year, assessed at screening visit\n* Unavailable for 6-week study duration (such as planned surgery or procedure, planned vacation, etc.) or unwilling to comply with study procedures\n* Not fluent in English\n* Unable to consent to recording of sessions\n\nCare Partner Inclusion Criteria:\n\n* Live in the same household as the study participant\n* Age 18 years or older\n* Fluent in English\n* Be willing to attend sessions alongside the study participant and learn how they can better support their partner participant to manage diabetes\n* Consent to recording of sessions","65 Years",{"count":126,"type":22},144,[25],"This study is designed to test the preliminary efficacy of a three-stage continuous glucose monitor (CGM) integration program for older adults who are taking insulin. This study will learn if a three-stage CGM integration program (\"intervention\") that includes sessions focused on CGM technology skills, data skills, and lifestyle skills impacts CGM wear-time, glycemic metrics, and participant-reported outcomes, compared to two standard CGM training approaches (\"comparators\").\n\nFollowing a screening visit and baseline data collection, participants will be randomized to either the intervention or one of the two comparator arms for 6 weeks. The intervention involves three educational sessions over 4 weeks. The first session will be in-person and subsequent sessions will be virtual. Participants in the intervention may receive 1-2 additional individualized training sessions to review CGM skills. The first comparator (Comparator 1) will receive a one-time clinic-based CGM training. The second comparator (Comparator 2) will be provided with a comprehensive informational pamphlet about CGM. All participants will complete outcomes data collection at 6 weeks.\n\nThe study will also explore participant experiences through a series of semi-structured interviews with a subset of purposively selected participants and their care partners to identify opportunities for scaling the intervention to a broader population. An extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention.\n\nLastly, we will run an additional small sub-study where consented care partners of participants will attend the intervention or comparator sessions alongside the study participant and provide care partner-specific data.",[130,131,132,133,134,135,30],"Insulin Dependent Diabetes","Diabetes (DM)","Diabetes (Insulin-requiring, Type 1 or Type 2)","Diabetes Education","Diabetes Care","Type 1 Diabetes (T1D)",[137,138,139,140,141,133],"Continuous Glucose Monitor","Diabetes","Insulin Dependent","Older Adults (65 years and older)","CGM",{"date":143,"type":45},"2026-08-14",{"date":145,"type":45},"2026-08-11",{"date":147,"type":22},"2028-06",{"name":149,"class":52},"University of North Carolina, Chapel Hill",{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":18,"minAge":96,"maxAge":124,"enrollmentInfo":157,"targetDuration":4,"studyType":23,"phases":159,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":53},"100628713","phase-2-a-study-to-evaluate-aln-4324-on-insulin-sensitivity-in-adults-with-type-2-diabetes-mellitus-100628713","NCT07465224","A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus","A Randomized, Double-blind, Placebo-controlled Study Investigating the Effect of ALN-4324 on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Is an adult patient with a confirmed diagnosis of T2DM\n* Has a body mass index (BMI) of ≥23 kg\u002Fm\\^2 to ≤39.9 kg\u002Fm\\^2\n* Has a hemoglobin A1c (HbA1c) ≥6.5% to \\\u003C10.5%\n* Is on a stable dose of metformin, sodium-glucose cotransporter 2 inhibitor (SGLT2i), or dipeptidyl peptidase-4 inhibitor (DPP4i)\n\nExclusion Criteria:\n\n* Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise participant safety or confound interpretation of study results\n* Receiving therapies known to interfere with glucose or insulin metabolism other than current treatment for T2DM or birth control methods\n\nNote: other protocol defined inclusion\u002Fexclusion criteria apply",{"count":158,"type":22},24,[160],"PHASE2","The purpose of this study is to evaluate the effect of a single dose of ALN-4324 on whole-body insulin sensitivity in participants with T2DM",[30],[164,165],"siRNA","RNAi",{"date":106,"type":45},{"date":168,"type":45},"2026-01-15",{"date":170,"type":22},"2027-05-28",{"name":172,"class":114},"Alnylam Pharmaceuticals",{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":18,"minAge":181,"maxAge":124,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":53},"100648849","digital-dietary-intervention-for-patients-receiving-glp-1-receptor-agonist-therapy-100648849","NCT07728669","Digital Dietary Intervention for Patients Receiving GLP-1 Receptor Agonist Therapy","Efficacy of a Digital Dietary Intervention (NutriSteppe Application) in Improving Metabolic Parameters in Adults With Type 2 Diabetes Mellitus, Obesity or Overweight With Comorbidities Who Are Receiving GLP-1 Receptor Agonist Therapy and Other Medications Prescribed Under Routine Clinical Protocols","NutriSteppe","Inclusion Criteria:\n\n* Age 21-65 years inclusive at the time of signing informed consent.\n* Male or female.\n* Overweight with at least one comorbidity, including diabetes mellitus; arterial hypertension of at least 130\u002F85 mmHg or use of antihypertensive medication; dyslipidemia defined as triglycerides of at least 1.7 mmol\u002FL, reduced HDL cholesterol below 1.0 mmol\u002FL in men or below 1.3 mmol\u002FL in women, or use of lipid-lowering medication; cardiovascular disease; respiratory or joint disease; non-alcoholic fatty liver disease; sleep disorders; or other comorbidities.\n* For participants with overweight: body mass index of 25.0-29.9 kg\u002Fm² for the Caucasian population or 23.0-27.4 kg\u002Fm² for the Asian population, together with abdominal obesity defined as waist circumference of at least 94 cm in men and 80 cm in women of the European population, or at least 90 cm in men and 80 cm in women of the Asian population.\n* Class I-III obesity where diet combined with physical activity has been ineffective, defined as weight loss of less than 5% over 3 months.\n* Class I obesity: body mass index of 30.0-34.9 kg\u002Fm² for the Caucasian population or 27.5-32.4 kg\u002Fm² for the Asian population.\n* Class II obesity: body mass index of 35.0-39.9 kg\u002Fm² for the Caucasian population or 32.5-37.4 kg\u002Fm² for the Asian population.\n* Type 2 diabetes mellitus with HbA1c of at least 6.5% (48 mmol\u002Fmol), fasting glucose of at least 6.1 mmol\u002FL in capillary whole blood or at least 7.0 mmol\u002FL in venous plasma, glucose of at least 11.1 mmol\u002FL two hours after an oral glucose tolerance test, or random glucose of at least 11.1 mmol\u002FL.\n* Body mass index of at least 25 kg\u002Fm² and no more than 40 kg\u002Fm² at screening.\n* Already receiving, or prescribed, GLP-1 receptor agonist therapy with semaglutide by the treating physician independently of the study. The study does not prescribe or modify this therapy.\n* Stable doses of medications for chronic conditions, including antihypertensive agents and statins, for at least 8 weeks before screening.\n* Ownership of an iOS or Android smartphone with internet access and willingness to download and use the \"NutriSteppe\" application if assigned to the intervention group.\n* Ability and willingness to provide written informed consent and comply with study procedures.\n* Women of childbearing potential must use effective contraception throughout the study.\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes mellitus.\n* History of diabetic ketoacidosis or hyperglycemic hyperosmolar state.\n* Initiation of GLP-1 receptor agonist therapy less than 4 weeks before screening.\n* Current insulin therapy.\n* Personal or family history of medullary thyroid carcinoma.\n* Personal history of multiple endocrine neoplasia type 2 (MEN2).\n* History of acute or chronic pancreatitis.\n* Active gallbladder disease or history of gallbladder disease within 6 months before screening.\n* Severe gastrointestinal disease, including gastroparesis.\n* Major cardiovascular event within 6 months before screening, including myocardial infarction, stroke, transient ischemic attack, unstable angina, coronary artery bypass grafting, or percutaneous coronary intervention.\n* Uncontrolled arterial hypertension, defined as systolic blood pressure above 160 mmHg or diastolic blood pressure above 100 mmHg at screening.\n* Chronic kidney disease with an estimated glomerular filtration rate below 30 mL\u002Fmin\u002F1.73 m² using the MDRD or CKD-EPI formula.\n* Severe hepatic impairment classified as Child-Pugh class C, or ALT or AST greater than three times the upper limit of normal.\n* Active malignancy or history of malignancy within 5 years, except successfully treated basal cell or squamous cell carcinoma of the skin.\n* Established HIV infection, active hepatitis B defined as HBsAg positive with detectable HBV DNA, or hepatitis C virus infection.\n* History of bariatric surgery or bariatric surgery planned during the study.\n* Anorexia nervosa, bulimia nervosa, or binge eating disorder diagnosed or active within the past year.\n* Pregnancy or breastfeeding.\n* Planning pregnancy during the study.\n* Woman of childbearing potential unwilling to use effective contraception.\n* Use of weight-loss medication, including orlistat, phentermine, combinations with topiramate, naltrexone-bupropion, or other weight-loss medication within 3 months before screening.\n* Use of systemic corticosteroids, excluding inhaled or topical corticosteroids, for more than 2 weeks within 3 months before screening.\n* Use of antipsychotic medication associated with significant weight gain unless used at a stable dose for more than 6 months.\n* Participation in another interventional clinical study within 30 days before screening.\n* Known hypersensitivity to semaglutide or any excipient.\n* No smartphone or unwillingness to use digital health technology.\n* Severe mental disorder impairing the ability to provide informed consent or comply with the protocol.\n* Active alcohol or drug dependence within the past year.\n* Any condition that, in the investigator's opinion, may compromise participant safety or the integrity of the study.","21 Years",{"count":183,"type":22},120,[25],"The goal of this clinical trial is to learn whether adding the NutriSteppe digital dietary intervention to routine medical care improves metabolic health in adults aged 21 to 65 years with type 2 diabetes mellitus, obesity, or overweight with related health conditions. Participants are already receiving or have been prescribed glucagon-like peptide-1 (GLP-1) receptor agonist therapy by their treating physicians outside the study.\n\nThe main question is:\n\nDoes the NutriSteppe digital dietary intervention improve glycated hemoglobin (HbA1c), a measure of average blood glucose, after 12 weeks compared with routine medical care alone?\n\nThe study will also assess changes in fasting blood glucose, body weight, body mass index, waist circumference, cholesterol, triglycerides, blood pressure, diet quality, quality of life, dietary adherence, and safety.\n\nResearchers will randomly assign participants to one of two groups. The control group will continue routine medical care and receive general lifestyle advice. The intervention group will continue routine medical care and use the NutriSteppe application for 12 weeks to receive personalized dietary support.\n\nParticipants in both groups will:\n\n* Attend study visits and complete the examinations, laboratory tests, and questionnaires specified in the study protocol.\n* Photograph everything they eat and drink.\n* Have their food photographs automatically analyzed using Tagam-AI, a system developed for this study.\n* Be able to view the results of the food photograph analysis.\n\nThe photography and automated analysis procedures will be the same in both groups. Only participants in the intervention group will receive personalized dietary recommendations generated from these data through the NutriSteppe application.",[30,187,104,188],"Obesity (Disorder)","Metabolic Syndrome",[179,190,191,72,192,193,194],"Digital Dietary Intervention","Personalized Nutrition","Semaglutide","Glycated Hemoglobin","HbA1c","2026-08-10",{"date":145,"type":45},{"date":198,"type":45},"2026-07-20",{"date":200,"type":22},"2027-01",{"name":202,"class":52},"Kazakh Academy of Nutrition",{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":18,"minAge":124,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":214,"briefSummary":215,"conditions":216,"keywords":219,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":53},"100651334","phase-2-hmb-plus-vitamin-d-to-preserve-muscle-in-older-adults-starting-semaglutide-100651334","NCT07760948","HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide","Preserving the Metabolic Engine: HMB Supplementation to Combat Iatrogenic Sarcopenia and Metabolic Adaptation in Older Adults Initiating Semaglutide Therapy","PRESERVE-HMB","Inclusion Criteria:\n\n* Age 65 to 85 years, inclusive.\n* Type 2 diabetes mellitus, defined by HbA1c at or above 6.5% or current use of antihyperglycemic medication.\n* Body mass index at or above 27 kg\u002Fm2.\n* Newly initiating semaglutide as standard clinical care under the direction of a treating clinician.\n* Able to walk 400 meters without assistance; use of a cane is permitted.\n* Able to understand and provide legally effective informed consent.\n* English speaking for the initial study because the consent documents, questionnaires, study-product instructions, safety instructions, and procedure-specific materials are available only in English.\n\nExclusion Criteria:\n\n* Estimated glomerular filtration rate below 45 mL\u002Fmin\u002F1.73 m2.\n* Use of HMB, creatine, or high-dose whey protein supplements within the previous 3 months.\n* Weight change greater than 5% during the previous 3 months.\n* Recent fracture within the previous 6 months.\n* Neuromuscular disease, including Parkinson disease, or another condition that would interfere with study outcomes or safe participation.\n* Chronic corticosteroid use.\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.\n* History of pancreatitis.\n* Smoking more than 7 cigarettes per day.\n* Previous malabsorptive or restrictive intestinal surgery or a malabsorptive syndrome.\n* Pregnancy or breastfeeding.\n* Recent history of neoplasia within the previous 5 years, as defined by the protocol.\n* Other active inflammatory conditions or neuromuscular disorders that could interfere with study outcomes or safety.\n* Serum 25-hydroxyvitamin D below 15 ng\u002FmL.\n* Any medical, functional, laboratory, medication-related, or safety condition that the investigator determines makes study participation unsafe or prevents completion of essential procedures.","85 Years",{"count":213,"type":22},90,[160],"This randomized, double-blind, placebo-controlled trial will evaluate whether daily calcium beta-hydroxy-beta-methylbutyrate (calcium-HMB) plus vitamin D3 preserves muscle mass, physical function, and resting metabolism in adults aged 65 to 85 years with type 2 diabetes who are newly starting semaglutide as part of usual clinical care. Participants will receive calcium-HMB plus vitamin D3 or matching placebo for approximately 6 months. The primary outcome is change in appendicular lean mass measured by dual-energy X-ray absorptiometry from baseline to month 6. Secondary assessments include body composition, muscle strength, physical performance, gait, physical activity, resting metabolic rate, metabolic measures, and whole-body quantitative computed tomography. An optional mechanistic substudy of up to 36 participants will include D3-creatine dilution, nonradioactive stable isotope infusions, repeated blood sampling, a standardized meal, breath sampling, and vastus lateralis muscle biopsies at baseline and month 6.",[30,217,103,218,34],"Sarcopenia","Muscle Loss",[220,221,222,223,224,225,226,227,228,229,230,231,232,233],"semaglutide","GLP-1 receptor agonist","beta-hydroxy-beta-methylbutyrate","HMB","calcium-HMB","vitamin D3","appendicular lean mass","metabolic adaptation","resting metabolic rate","skeletal muscle","older adults","D3-creatine","muscle protein synthesis","muscle protein breakdown","2026-08-07",{"date":106,"type":45},{"date":237,"type":22},"2026-12-01",{"date":239,"type":22},"2030-11",{"name":241,"class":52},"Vanderbilt University Medical Center",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":18,"minAge":249,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":53},"100651210","brain-heart-axis-in-type-2-diabetes-mellitus-100651210","NCT07757308","Brain-Heart Axis in Type 2 Diabetes Mellitus","Effects of Metabolic Dysfunction on Functional Capacity and Mental Health Through the Brain-Heart Axis in Type 2 Diabetes Mellitus: A Cross-Sectional Study Based on Electroencephalography and Heart Rate Variability","Inclusion Criteria:\n\n* Adults aged 40 to 75 years.\n* Confirmed diagnosis of Type 2 Diabetes Mellitus (T2DM).\n* Able to understand the study procedures and provide written informed consent.\n* Able to complete all planned clinical, neurophysiological, cognitive, and functional assessments.\n\nExclusion Criteria:\n\n* Diagnosis of neurological, psychiatric, orthopedic, or other systemic diseases that may influence study outcomes.\n* Cognitive or psychological impairment preventing completion of study assessments.\n* History of recent surgery or acute medical condition affecting participation.\n* Inability or unwillingness to provide written informed consent.\n* Inability to complete the assessment protocol.","40 Years","75 Years",{"count":252,"type":22},46,"Type 2 Diabetes Mellitus (T2DM) is associated with chronic hyperglycemia and metabolic disturbances that affect not only glucose metabolism but also the central nervous system, autonomic nervous system, and cardiovascular function. Growing evidence suggests that individuals with T2DM are at increased risk of cognitive impairment, autonomic dysfunction, reduced functional capacity, and psychological distress. However, the interactions among metabolic status, brain activity, cardiac autonomic regulation, functional performance, and mental health have not been comprehensively investigated within a single study.\n\nThis cross-sectional study aims to investigate the relationships between metabolic abnormalities and brain-heart axis function in adults with T2DM. Approximately 50 participants aged 40-65 years with a confirmed diagnosis of T2DM will undergo comprehensive assessments, including resting electroencephalography (EEG), heart rate variability (HRV), functional capacity tests (1-Minute Sit-to-Stand Test and 6-Minute Walk Test), cognitive function using the Montreal Cognitive Assessment (MoCA), physical activity using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), and psychological status using the Depression Anxiety Stress Scale (DASS-21). Clinical and metabolic variables, including HbA1c, fasting blood glucose, lipid profile, and inflammatory markers, will also be collected from medical records.\n\nThe primary objective is to determine whether metabolic disturbances are associated with alterations in EEG-derived brain activity and HRV-derived autonomic function and whether these changes are related to cognitive performance, functional capacity, physical activity, and psychological well-being. Correlation analyses, path analysis, and structural equation modeling will be used to explore direct and indirect relationships among these variables. The findings are expected to improve understanding of the brain-heart axis in T2DM and provide evidence for multidimensional assessment strategies to support early detection of neurocardiac dysfunction and optimize rehabilitation approaches.",[30],[256,257,258,259,260],"Type 2 Diabetes Mellitus","Electroencephalography (EEG)","Heart Rate Variability","Brain-Heart Axis","Functional Capacity","2026-08-05",{"date":145,"type":45},{"date":264,"type":45},"2026-06-25",{"date":266,"type":22},"2026-09-30",{"name":268,"class":52},"Hacettepe University",{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":18,"minAge":276,"maxAge":250,"enrollmentInfo":277,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":281,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":4},"100650981","the-effect-of-bitter-orange-citrus-aurantium-oil-aromatherapy-on-sleep-quality-and-fatigue-levels-100650981","NCT07756151","THE EFFECT OF BITTER ORANGE (CITRUS AURANTIUM) OIL AROMATHERAPY ON SLEEP QUALITY AND FATIGUE LEVELS","THE EFFECT OF BITTER ORANGE OIL INHALATION AROMATHERAPY ON SLEEP QUALITY AND FATIGUE LEVELS IN PATIENTS WITH TYPE 2 DIABETES MELLITUS","Inclusion Criteria:\n\n* being over the age of 19,\n* having no communication problem, and voluntarily agreeing to participate in the research,\n* having been admitted to the clinic at least 24 hours ago,\n* not having a diagnosed sleep disorder,\n* not having a psychiatric disorder requiring treatment,\n* not using narcotic drugs in the last 4 hours,\n* not eating two hours before going to bed at night,\n* not being pregnant,\n* not smoking,\n* not diagnosed acute rhinitis, sinusitis, or history of loss of smell.\n\nExclusion Criteria:\n\n* being under the age of 19,\n* not being conscious, refusing to participate in the research or opting to leave the study at any point,\n* having a diagnosed sleep disorder.","20 Years",{"count":63,"type":22},[25],"This study will be conducted to examine the effect of bitter orange oil inhalation aromatherapy on sleep quality and fatigue levels in patients with Type 2 Diabetes Mellitus (DM). The study will be conducted in the Endocrinology clinic of a university hospital in Türkiye. The research sample will consist of 100 adult patients. Patients will be randomly divided into two groups: the intervention and control groups. Patients in the intervention group will have three drops of bitter orange oil placed on a small cotton ball each night close to bedtime for three consecutive days. They will then hold the cotton ball 5 cm away from their nose and inhale it for one minute while breathing normally. After three consecutive nights of this procedure, sleep quality and fatigue levels will be measured on the morning of the fourth day. Patients in the control group will undergo the same procedure, but instead of orange oil, they will inhale water into the cotton ball.",[30],[282,283,284],"fatigue","sleep quality","inhalation of bitter orange oil","2026-08-04",{"date":195,"type":45},{"date":288,"type":22},"2026-09-15",{"date":290,"type":22},"2027-01-20",{"name":292,"class":52},"Uludag University",{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":18,"minAge":301,"maxAge":302,"enrollmentInfo":303,"targetDuration":4,"studyType":23,"phases":305,"briefSummary":306,"conditions":307,"keywords":315,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":53},"100605783","the-groceries-aimed-at-increasing-nutrition-study-100605783","NCT07167004","The GRoceries Aimed at Increasing Nutrition Study","Prompting a Switch From Refined Grains to Whole Grains in an Online Grocery Store Using Marketing Nudges and Financial Incentives","GRAINS","Inclusion Criteria:\n\n* Age 45 - 70 years.\n* Able to provide consent.\n* Resident of Philadelphia, Bucks, Delaware, Chester, or Montgomery Counties in Pennsylvania.\n* Consume \\\u003C5 servings of whole grains per day.\n* Use online grocery shopping at least once per month.\n* Have access to a credit or debit card to pay for groceries purchased.\n* Have reliable internet access.\n* Speak English.\n* Penn Medicine patient diagnosed with prediabetes or diabetes (identified using ICD-10 codes R73.03, E11).\n\nExclusion Criteria:\n\n* Does not meet all the inclusion criteria.\n* Not able to speak English.\n* Not able to provide consent.","45 Years","70 Years",{"count":304,"type":22},216,[25],"Only 2% of Americans meet the recommended levels of whole grain consumption, despite its association with reduced risk of type 2 diabetes. This study aims to assess if consumers with prediabetes or type 2 diabetes can be encouraged to switch from buying refined grain products to whole grain products when shopping for groceries online. The study will use personalized marketing strategies, with or without discounts which adjust based on purchasing behavior, to promote whole grain consumption.",[308,309,310,311,312,313,30,256,314],"Type 2 Diabetes","Type II Diabetes Mellitus","Type II Diabetes","Pre-diabetes","Pre-diabetic","Pre-diabetic State","Type 2 Diabetes (T2DM)",[316,317,318,319,320,321,322,323,324,325,326,327],"chronic disease","diabetes","diabetes mellitus","type II diabetes","type 2 diabetes","pre-diabetes","prediabetes","whole grains","behavioral economics","marketing nudges","financial incentives","food is medicine","2026-08-03",{"date":330,"type":45},"2026-08-06",{"date":332,"type":45},"2025-10-14",{"date":334,"type":22},"2027-02-16",{"name":336,"class":52},"University of Pennsylvania",{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":18,"minAge":96,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":347,"conditions":348,"keywords":349,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":53},"100580375","using-continuous-glucose-monitoring-to-quantify-the-effects-of-nourishs-culturally-modified-meals-on-asian-americans-with-type-2-diabetes-100580375","NCT06836479","Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes","Validation of NOURISH Project's Culturally Tailored Meals on Postprandial Glycemic Response Using Continuous Glucose Monitoring: A Quantitative and Qualitative Study","Inclusion Criteria:\n\n* Self-identification as Asian Indian or Filipino\n* Diagnosed with T2DM\n* Pick up and consume personally tailored cultural food and meal options for 1 week\n* Willing to wear a CGM for 30 days\n\nExclusion Criteria:\n\n* Currently taking insulin\n* Known severe allergic reactions and\u002For food intolerances that would interfere with the ability to eat\n* Those who, in the opinion of the investigators, cannot reliably complete the study protocol.",{"count":345,"type":22},30,[25],"The investigators are hoping to determine whether tailoring the diet of someone with type 2 diabetes to their ethnic group while following American Diabetes Association guidelines can make a significant difference in their blood sugar controls. Participants will be required to wear a Continuous Glucose Monitor (CGM) for 1-month so that the investigators can compare blood sugar levels when participants are eating their routine diet vs. the culturally tailored diabetes diet.",[30,308],[308,350,351,352,353,354,355,356,357,358,359],"Asian American","Asian Indian","Filipino","Medically Tailored Meals","Culture","Culturally Tailored Meals","Continuous Glucose Monitoring","Nutritional Interventions","Dietary Adherence","Diabetes Management","2026-08-01",{"date":285,"type":45},{"date":363,"type":22},"2026-08",{"date":365,"type":22},"2026-11",{"name":367,"class":52},"Stanford University",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":18,"minAge":96,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":23,"phases":377,"briefSummary":378,"conditions":379,"keywords":384,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":53},"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":376,"type":22},200,[25],"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.",[380,381,382,383,30],"Food Insecurities","Cardiometabolic Comorbidities","HIV","PreDiabetes",[385],"Food Insecurity","2026-07-31",{"date":285,"type":45},{"date":389,"type":45},"2023-12-01",{"date":391,"type":22},"2027-02-28",{"name":393,"class":52},"Wake Forest University Health Sciences",{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":401,"sex":18,"minAge":96,"maxAge":4,"enrollmentInfo":402,"targetDuration":4,"studyType":23,"phases":404,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":412,"leadSponsor":414,"locationsCount":53},"100643819","investigating-vascular-properties-of-hemi-and-spg-signals-in-individuals-with-or-at-risk-for-chronic-kidney-disease-100643819","NCT07604922","Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease","STIMULUS-CKD","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n\n  * Adults aged over 18 years, of both sexes\n  * Patients eligible for or affiliated with a social security scheme\n  * Patients who have provided written informed consent to participate in the study\n\nCommon Exclusion Criteria:\n\n* Inability to give informed consent\n* Persons under legal protection (guardianship, trusteeship, or court protection)\n* Language barrier or psychological refusal to read the information\n* Medical conditions with a life expectancy \\\u003C 1 year according to clinical judgment\n* Ongoing participation restriction due to another clinical research study\n* Pregnant women (due to physiological hemodynamic changes in blood pressure and arterial stiffness during pregnancy)\n* Cardiac arrhythmias: current atrial fibrillation or high-degree atrioventricular block\n\nExclusion Criteria:\n\n* Hypertension Group\n\n  * Inclusion: Prior diagnosis of arterial hypertension\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n\n    * CKD with GFR \\\u003C60 mL\u002Fmin\n    * ACR \\> 30 mg\u002Fmmol\n    * Type 2 diabetes Type 2 Diabetes Group\n  * Inclusion:\n  * Prior diagnosis of type 2 diabetes\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n\n    * CKD with GFR \\\u003C 60 mL\u002Fmin\n    * ACR \\> 30 mg\u002Fmmol Moderate CKD Group\n  * Inclusion:\n  * Moderate CKD (eGFR between 30 and 60 mL\u002Fmin) (CKD-EPI)\n  * Patients scheduled for arterial stiffness assessment as part of routine care\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n  * No specific exclusion criteria beyond common exclusions Severe CKD Group\n  * Inclusion:\n\n    * Severe CKD (GFR \\\u003C 30 mL\u002Fmin for ≥ 2 months)\n    * Patients scheduled for arterial stiffness assessment as part of routine care\n    * Stable cardiovascular treatment the previous 1 month\n  * Exclusion: No specific exclusion criteria beyond common exclusions20 \u002F 48 C25-07\\_Protocole\\_ V1.0\\_01.12.2025 Healthy Volunteers Group\n  * Inclusion: No documented chronic disease\n  * Exclusion:\n\n    * Moderate or severe CKD (GFR \\\u003C 60 mL\u002Fmin) (CKD-EPI)\n    * Hypertension\n    * Type 2 diabetes\n    * Stable cardiovascular treatment in the previous 1 month",true,{"count":403,"type":22},165,[25],"This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. The study will include 165 participants divided into five groups (33 per group): healthy volunteers, patients with hypertension without chronic kidney disease (CKD), patients with type 2 diabetes without CKD, patients with moderate CKD, and patients with severe CKD. The primary objective is to compare baseline small vessel pressure measured with the HEMI (Multi-spectral optical system for microcirculation hemodynamics) device across groups in order to identify microvascular alterations associated with cardiometabolic and renal disease. Secondary objectives include assessment of microvascular responses after post-ischemic hyperemia, evaluation of SPG-derived (Speckle plethysmography) small vessel flow and volume parameters, comparison with reference vascular measurements (including SphygmoCor and ultra-high frequency ultrasound), and evaluation of feasibility, acceptability, and measurement reproducibility. Participation is non-randomized, based on participants' pre-existing clinical condition, and study procedures are non-invasive with an expected visit duration of approximately 60 minutes.",[407,408,30],"Chronic Kidney Disease","Hypertension (HTN)","2026-07-30",{"date":386,"type":45},{"date":288,"type":22},{"date":413,"type":22},"2028-09-15",{"name":415,"class":416},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":401,"sex":18,"minAge":96,"maxAge":124,"enrollmentInfo":425,"targetDuration":427,"studyType":65,"phases":4,"briefSummary":428,"conditions":429,"keywords":432,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":53},"100649406","evaluation-of-neuregulin-4-nrg4-levels-in-obese-and-non-obese-patients-with-type-2-diabetes-mellitus-100649406","NCT07734558","Evaluation of Neuregulin-4 (NRG4) Levels in Obese and Non-Obese Patients With Type 2 Diabetes Mellitus","Evaluation of the Relationship Between Serum Neuregulin-4 (NRG4) Levels, Obesity Status, and Antidiabetic Treatment Regimens in Patients With Type 2 Diabetes Mellitus: A Prospective Observational Study","NRG4-T2DM","Inclusion Criteria:\n\n* Age 18-65 years\n* Newly diagnosed treatment-naïve T2DM\n* T2DM treated for at least 6 months\n* BMI \\>30 kg\u002Fm²\n* BMI \\\u003C25 kg\u002Fm²\n* No pregnancy\n* No breastfeeding\n* No active infection\n* No inflammatory disease\n* Written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Pregnancy\n* Breastfeeding\n* Active infection\n* Rheumatologic disease\n* Refusal to participate",{"count":426,"type":22},125,"1 Day","This prospective observational study aims to evaluate serum Neuregulin-4 (NRG4) concentrations in obese and non-obese adults with Type 2 Diabetes Mellitus (T2DM) and to investigate their association with obesity status, insulin resistance, and different antidiabetic treatment regimens. Participants will be categorized into five predefined groups according to obesity status and treatment regimen, including SGLT2 inhibitor users, non-SGLT2 oral antidiabetic therapy users, SGLT2 combination therapy users, newly diagnosed treatment-naïve patients, and healthy controls. Clinical, anthropometric, and laboratory parameters including fasting plasma glucose, HbA1c, estimated glomerular filtration rate (eGFR), body mass index, waist circumference, waist-to-hip ratio, and serum NRG4 concentrations will be evaluated. The study aims to determine whether NRG4 may serve as a novel biomarker reflecting metabolic status and treatment response in patients with T2DM.",[30,430,431],"Obesity Type 2 Diabetes Mellitus","Insulin Resistance",[433,434,256,103,435],"Neuregulin-4","NRG4","Adipokine","2026-07-27",{"date":438,"type":45},"2026-07-29",{"date":440,"type":22},"2026-06",{"date":442,"type":22},"2026-12-30",{"name":444,"class":52},"GÜLDEN ANATACA",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":18,"minAge":96,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":53},"100648906","multilingual-voice-calls-to-adjust-long-acting-insulin-for-adults-with-type-2-diabetes-and-low-health-literacy-in-pakistan-100648906","NCT07729501","Multilingual Voice Calls to Adjust Long-Acting Insulin for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan","Multilingual Voice-Based Insulin Titration for Adults With Type 2 Diabetes and Low Health Literacy in Pakistan: A Randomized Trial","VOICE-TITR-PK","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosed with type 2 diabetes mellitus.\n* Currently receiving basal insulin or considered by the treating clinician to require initiation or adjustment of basal insulin.\n* Glycemic control considered inadequate and requiring basal insulin titration according to the study protocol.\n* Low health literacy as determined using the study-approved screening method.\n* Able to communicate in one of the languages supported by the study intervention.\n* Has access to a functioning feature phone or mobile telephone and is able to receive automated voice calls.\n* Able and willing to perform fasting blood glucose monitoring according to the study procedures.\n* Willing and able to provide informed consent.\n* Willing to comply with study procedures and complete the 12-week follow-up.\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus, gestational diabetes, or another specific form of diabetes other than type 2 diabetes mellitus.\n* Pregnancy, current breastfeeding, or planned pregnancy during the study period.\n* Current use of an insulin pump.\n* Severe hypoglycemia requiring assistance from another person within the period specified in the protocol before enrollment.\n* Recurrent hypoglycemia or another clinical condition that, in the investigator's judgment, makes protocol-directed insulin titration unsafe.\n* Acute metabolic decompensation, including diabetic ketoacidosis or hyperosmolar hyperglycemic state, at screening or within the period specified in the protocol.\n* Severe renal, hepatic, cardiac, psychiatric, cognitive, hearing, or other medical impairment that would prevent safe participation or completion of the voice-call intervention.\n* Inability to understand or respond to the study's supported voice-call languages.\n* Inability to use the telephone or glucose-monitoring procedures, with or without assistance permitted by the protocol.\n* Current participation in another interventional clinical trial that could interfere with the study outcomes.\n* Any other condition that, in the investigator's judgment, would make participation unsafe or compromise adherence to the study procedures.",{"count":454,"type":22},220,[25],"This study will evaluate whether a multilingual, feature-phone interactive voice response (IVR) system with human-verified basal insulin titration improves glycemic control compared with standard clinic-based insulin titration among adults with type 2 diabetes and low health literacy in Pakistan. Approximately 220 participants will be randomly assigned to either the IVR-supported titration strategy or usual clinic-based care. Participants will be followed for 12 weeks, with the primary outcome being change in glycated hemoglobin (HbA1c) from baseline to Week 12. Secondary outcomes include fasting plasma glucose, insulin dose adjustment, hypoglycemia, treatment adherence, patient satisfaction, health literacy-related outcomes, and implementation measures.",[30,458],"Hyperglycemia Due to Type 2 Diabetes Mellitus",[256,460,461,462,463,464,465,466,467,468],"Basal Insulin","Insulin Titration","Interactive Voice Response","Telemedicine","Mobile Health","Digital Health","Health Literacy","Glycemic Control","Pakistan","2026-07-26",{"date":471,"type":45},"2026-07-28",{"date":473,"type":22},"2026-09-25",{"date":475,"type":22},"2027-03-01",{"name":477,"class":52},"Shifa International Hospital",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":18,"minAge":96,"maxAge":124,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":496,"leadSponsor":498,"locationsCount":4},"100649410","phase-4-fecal-microbiota-transplantation-for-type-2-diabetes-mellitus-and-hashimotos-thyroiditis-100649410","NCT07733232","Fecal Microbiota Transplantation for Type 2 Diabetes Mellitus and Hashimoto's Thyroiditis","Efficacy of Fecal Microbiota Transplantation in Improving Metabolic Parameters and Immune Dysregulation in Patients With Concurrent Type 2 Diabetes Mellitus and Autoimmune Thyroid Disease.","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 65 years old.\n2. Diagnosed with type 2 diabetes mellitus (T2DM).\n3. Positive for thyroid peroxidase antibody (TPOAb) and thyroglobulin antibody (TgAb); thyroid ultrasonography indicates diffuse thyroid lesions.\n4. The regimens of hypoglycemic drugs and thyroid-related basic treatments (including drug types and dosages) have remained stable for at least 3 months before enrollment.\n\nExclusion Criteria:\n\n1. Subjects who have used antibiotics, probiotics or prebiotics within 4 weeks prior to screening.\n2. Patients complicated with severe gastrointestinal diseases (e.g., inflammatory bowel disease, active gastrointestinal bleeding).\n3. Patients receiving specialized treatment for hyperthyroidism (Graves' disease) or with a history of thyroid malignancy.\n4. Patients with severe immunosuppression (neutrophil count \\\u003C 1500\u002Fmm³, lymphocyte count \\\u003C 500\u002Fmm³).\n5. Patients with active severe gastrointestinal bleeding, intestinal perforation, or severe intestinal barrier\u002Fmucosal injury.\n6. Patients with intestinal mucosal injury of unknown etiology.\n7. Patients diagnosed with fulminant colitis or toxic megacolon.\n8. Patients with active extraintestinal infection requiring treatment with broad-spectrum antibiotics.\n9. Severe malnutrition (body mass index \\\u003C 15 kg\u002Fm²) or severe hypoalbuminemia (serum albumin \\\u003C 25 g\u002FL).\n10. Congenital or acquired immunodeficiency diseases.\n11. Patients who have recently received high-risk immunosuppressants or cytotoxic drugs (e.g., rituximab, doxorubicin), or medium-to-high dose glucocorticoids (e.g., prednisone \\>= 20 mg per day for more than 4 consecutive weeks).\n12. Patients complicated with other autoimmune diseases.\n13. Patients with severe hepatic or renal insufficiency.\n14. Patients with malignant tumors.\n15. Patients with known allergy to capsule ingredients.\n16. Pregnant or lactating females.",{"count":486,"type":22},38,[488],"PHASE4","The goal of this clinical trial is to learn if fecal microbiota transplantation (FMT) can improve metabolic control and immune function in adults with both type 2 diabetes and Hashimoto's thyroiditis (an autoimmune thyroid disease). It will also learn about the safety of FMT in these patients. The main questions it aims to answer are:\n\nCan FMT lower blood sugar levels (HbA1c, fasting blood glucose, and 2-hour post-meal blood glucose) in participants with type 2 diabetes? Can FMT reduce thyroid autoantibody levels (TPOAb and TgAb) in participants with Hashimoto's thyroiditis? This is a single-arm study, meaning all participants will receive the same FMT treatment. Researchers will compare each participant's results before and after the intervention to see if FMT has an effect.\n\nParticipants will:\n\nComplete baseline tests including blood work and stool sample collection during the 2-week screening period Take 40 oral FMT capsules by mouth over about 1.5 hours under medical supervision at the start of the study Keep taking their usual diabetes and thyroid medications at the same dose throughout the study, unless their doctor says otherwise Return for follow-up visits and tests at 12 weeks and 24 weeks after the FMT treatment",[491,30,492],"Autoimmune Thyroid Disease","FMT","2026-07-23",{"date":438,"type":45},{"date":363,"type":22},{"date":497,"type":22},"2027-12",{"name":499,"class":416},"Shen Xujun",{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":514,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":53},"100648389","phase-4-cilostazol-and-aspirin-for-cardiovascular-event-prevention-in-patients-with-type-2-diabetes-100648389","NCT07719894","Cilostazol and Aspirin for Cardiovascular Event Prevention in Patients With Type 2 Diabetes","Comparison of Efficacy and Safety Between Aspirin and Cilostazol on Cardiovascular Event in Patients at High Risk of Cardiovascular Disease, Randomization.","Cilo-Asa","Inclusion Criteria:\n\n* Individuals with type 2 diabetes mellitus were eligible if they were aged ≥19 years\n* Individuals with subclinical atherosclerosis or metabolic syndrome, defined as at least one of the following:\n* Carotid intima-media thickness ≥ 1 mm\n* Ankle-brachial index \\\u003C 0.9 - Pulse wave velocity ≥ 9 m\u002Fs\n* Flow-mediated vasodilatation \\\u003C 5%\n* Coronary artery calcium score ≥ 40\n* Coronary artery stenosis ≥ 20% or ≤ 70%\n* Peripheral artery occlusive disease ≥ 20%\n* Metabolic syndrome\n* Individuals with HbA1c ≤ 9.9%\n* Individuals who voluntarily agree to participate in the study and provide written informed consent\n\nExclusion Criteria:\n\n* Patients with a history of major cardiovascular events, including myocardial infarction, stroke, or heart failure\n* Patients with heart failure (NYHA I\\~IV)\n* Patients with current active bleeding or suspected bleeding\n* Patients with suspected bleeding tendency or hematologic disorder, such as hemophilia or thrombocytopenia\n* Patients recently diagnosed with gastrointestinal ulcerative disease\n* Patients with inadequately controlled hypertension, defined as systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg\n* Patients with severe renal dysfunction, defined as estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²\n* Patients with liver enzyme levels greater than 3 times the upper limit of normal or chronic liver disease\n* Individuals currently taking antiplatelet or antithrombotic agents\n* Individuals who are pregnant or breastfeeding\n* Patients with a history of hypersensitivity to any component of the study drugs\n* Patients with complications of coronary artery stenosis\n* Patients with QT prolongation\n* Patients with a sigmoid-shaped ventricular septum or risk of sigmoid-shaped ventricular septum\n* Individuals with alcohol addiction\n* Patients with asthma\n* Patients deemed unsuitable for participation in the study based on the investigator's judgment",{"count":509,"type":22},1200,[488],"Patients with type 2 diabetes and cardiovascular risk factors are at increased risk of cardiovascular events. Therefore, a multi-center prospective randomized study will be conducted to compare the efficacy and safety of cilostazol and aspirin for the prevention of major adverse cardiac and cerebrovascular events (MACCE) in high-risk patients with type 2 diabetes.",[30,513],"Atherosclerosis",[515,516,517],"Major Adverse Cardiac and Cerebrovascular Events","Cilostazol","Aspirin","2026-07-19",{"date":520,"type":45},"2026-07-22",{"date":522,"type":45},"2026-05-06",{"date":524,"type":22},"2028-12-31",{"name":526,"class":52},"Seoul National University Bundang Hospital",{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":401,"sex":534,"minAge":96,"maxAge":301,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":537,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":53},"100638341","phase-1-a-phase-i-study-of-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-single-subcutaneous-ubt38006-injection-in-healthy-adult-males-100638341","NCT07630233","A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of UBT38006 Injection in Healthy Adult Male Subjects","Inclusion Criteria:\n\n* Aged 18-45 years (inclusive) at the time of informed consent form (ICF) signing;\n* Sex: Male;\n* Body weight ≥50.0 kg and body mass index (BMI) between 19.0-24.0 kg\u002Fm² (BMI = weight \\[kg\\] \u002F height² \\[m²\\]), inclusive, at Screening;\n* Fasting plasma glucose (FPG) between 3.9-6.1 mmol\u002FL (exclusive of boundary values) at Screening; 2-hour plasma glucose \\\u003C7.8 mmol\u002FL on oral glucose tolerance test (OGTT) at Screening; insulin release test (IRT) results normal, or abnormal but judged by the Investigator as not clinically significant (NCS)at Screening; glycated hemoglobin (HbA1c) ≤6.0% at Screening;\n* The subject (including his partner) is willing to use adequate and effective contraception voluntarily from Screening through 3 months after administration of the investigational medicinal product (IMP) (see Appendix 2 for details), and has no plan to donate sperm within 3 months after IMP administration;\n* The subject is able to communicate well with the Investigator, has adequate understanding of this study, participates voluntarily, understands and complies with all study requirements, and provides written informed consent.\n\nExclusion Criteria:\n\n* History of severe hypersensitivity (e.g., allergy to three or more allergens, allergic asthma involving the lower respiratory tract, or allergy requiring systemic corticosteroid therapy) or known hypersensitivity to any component of the investigational medicinal product;\n* History of severe or currently clinically significant disease\u002Fcondition (including but not limited to diseases of the nervous, cardiovascular, respiratory, hematologic and lymphatic, immune, renal, hepatic, gastrointestinal, metabolic, and skeletal systems, history of malignancy, or neurological or psychiatric disease\u002Fcondition);\n* History of orthostatic hypotension, syncope, or amaurosis, or first-degree relative with history of diabetes mellitus;\n* Laboratory abnormalities (hematology, blood chemistry, coagulation function, thyroid function, urinalysis, stool routine, etc.) at Screening that are judged by the Investigator as clinically significant;\n* Positive insulin autoantibody (IAA) at Screening;\n* Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody, or Treponema pallidum antibody at Screening;\n* History of drug abuse, or positive urine drug screen prior to randomization;\n* Clinically significant abnormalities on physical examination, electrocardiogram (ECG), or vital signs (body temperature, pulse, blood pressure);\n* Use of insulin-containing agents within 3 months prior to dosing, or use of any other medication (including traditional Chinese medicine, over-the-counter drugs, etc.) within 30 days prior to dosing;\n* Vaccination with any vaccine within 1 month prior to dosing;\n* History of surgery within 3 months prior to dosing, or planned surgery during the entire study period;\n* History of blood loss or blood donation exceeding 200 mL within 3 months prior to dosing (calculated from the day before dosing);\n* Hemoglobin below the lower limit of normal (LLN);\n* Participation in other interventional clinical trials within 3 months prior to dosing (except for subjects who only underwent screening but were not enrolled, or were enrolled but did not receive treatment);","MALE",{"count":536,"type":22},53,[538],"PHASE1","This study is a single-center, randomized, double-blind, placebo- and active-controlled, parallel-group, single-ascending dose (SAD) design. Insulin degludec and insulin icodec injection serves as the active control and is administered in an open-label manner.\n\nThe study will be conducted across 6 cohorts, comprising 4 dose-escalation cohorts of UBT38006 (1, 3, 6, and 12 nmol\u002Fkg) ， 1 active control cohort of insulin degludec (0.4 U\u002Fkg \\[2.4 nmol\u002Fkg\\]) and 1 active control cohort of insulin icodec (1.25 U\u002Fkg \\[7.5 nmol\u002Fkg\\]). The safety and tolerability (including local tolerability) as well as the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single subcutaneous doses of UBT38006 injection will be evaluated in healthy adult male participants.\n\nIn Cohort 1 (1 nmol\u002Fkg), participants will be randomized in a 4:1 ratio to receive UBT38006 injection or placebo. In Cohorts 2-4 (3, 6, and 12 nmol\u002Fkg), participants will be randomized in an 8:2 ratio to receive the corresponding dose of UBT38006 injection or placebo. Participants in Cohort 5 (insulin degludec active control) will receive 0.4 U\u002Fkg (2.4 nmol\u002Fkg) insulin degludec injection. Participants in the insulin icodec cohort received a subcutaneous injection of insulin icodec at a dose of 1.25 U\u002Fkg(7.5 nmol\u002Fkg). Cohorts 1-4 will follow a double-blind design, while Cohort 5 and insulin icodec cohort will be open-label.",[30],"2026-07-16",{"date":198,"type":45},{"date":544,"type":22},"2026-06-19",{"date":546,"type":22},"2026-10-25",{"name":548,"class":114},"The United Bio-Technology (Hengqin) Co., Ltd.",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":96,"maxAge":19,"enrollmentInfo":556,"targetDuration":4,"studyType":23,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":570,"leadSponsor":572,"locationsCount":4},"100647971","efficacy-and-safety-of-mazdutide-in-patients-with-type-2-diabetes-mellitus-and-moderate-to-severe-nonalcoholic-fatty-liver-disease-previously-treated-with-semaglutide-100647971","NCT07713992","Efficacy and Safety of Mazdutide in Patients With Type 2 Diabetes Mellitus and Moderate to Severe Nonalcoholic Fatty Liver Disease Previously Treated With Semaglutide","Efficacy and Safety of Mazdutide in Patients With Type 2 Diabetes Mellitus and Moderate to Severe Nonalcoholic Fatty Liver Disease Previously Treated With Semaglutide: A Multicenter, Prospective, Randomized Controlled Trial (IIT)","Inclusion Criteria:\n\n* Aged between 18 and 60 years (inclusive) at the time of informed consent signing.\n* Diagnosed with type 2 diabetes mellitus.\n* Received once-weekly semaglutide 1.0 mg treatment for at least 16 consecutive weeks verified by medication records.\n* Diagnosed with moderate-to-severe fatty liver, defined as hepatic attenuation ≥269 dB\u002Fm by transient elastography and hepatic fat fraction \\>10% measured by MRI-PDFF.\n* HbA1c level \\\u003C7%.\n* Body mass index (BMI) ≥24 kg\u002Fm².\n* Glycemic and weight management regimens without adjustments within 3 months prior to screening.\n* Voluntarily signed written informed consent and agreed to comply with the study protocol.\n\nExclusion Criteria:\n\n* History of alcoholic fatty liver, drug-induced fatty liver, viral hepatitis, autoimmune diseases, or acute gallbladder diseases.\n* Use of medications affecting fatty liver metabolism within 3 months prior to screening, including but not limited to SGLT-2 inhibitors, vitamin E, GLP-1R\u002FGIPR agonists, liver-selective thyroid receptor β agonists, PPAR agonists, and aspirin.\n* Use of weight-loss drugs or alternative weight-loss therapies within 3 months prior to screening.\n* Addition to sulfonylureas, glinides, dorzagliatin, or various insulin preparations within 3 months prior to screening.\n* History of bariatric surgery or planned bariatric surgery during the study (excluding acupuncture, liposuction and abdominal liposuction performed more than 1 year before screening).\n* Diagnosed with type 1 diabetes or latent autoimmune diabetes in adults.\n* Personal history of acute or chronic pancreatitis, personal or family history of medullary thyroid carcinoma (MTC), or family history of multiple endocrine neoplasia type 2 (MEN2).\n* Presence of severe cardiovascular, cerebrovascular, hepatic or renal insufficiency, uncontrolled diabetes, malignancy, cirrhosis or advanced liver fibrosis.\n* Pregnant or lactating females, those planning pregnancy within half a year, or with recent major surgery or severe infection.\n* Mental disorders or cognitive disorders that may interfere with study compliance, or any other conditions judged inappropriate for study participation by the investigator.\n* Contraindications to MRI examination, including implantation of pacemakers, metallic heart valves, magnetic surgical clips, implantable electronic infusion pumps, severe claustrophobia, or inability to tolerate MRI scanning.",{"count":557,"type":22},72,[25],"This is a multicenter, prospective, randomized controlled investigator-initiated trial (IIT) aimed at evaluating the efficacy and safety of switching to mazdutide therapy in patients with type 2 diabetes mellitus (T2DM) and moderate-to-severe non-alcoholic fatty liver disease (NAFLD) who have achieved glycemic control.\n\nChinese patients with type 2 diabetes mellitus (T2DM) are susceptible to visceral fat accumulation, which increases the risk of cardiometabolic diseases and mortality. Metabolic associated fatty liver disease (MAFLD) is highly prevalent among Chinese T2DM patients, and the coexistence of T2DM and moderate-to-severe fatty liver significantly elevates liver-related and all-cause mortality. The vicious cycle of hepatic lipid deposition and insulin resistance aggravates T2DM progression, while weight loss has been proven to alleviate hepatopancreatic fat accumulation and improve the management of T2DM.\n\nGLP-1 receptor agonists (GLP-1RAs) including semaglutide are standard therapies for T2DM with glycemic improvement and weight-loss benefits. However, nearly a quarter of patients show poor response to semaglutide. Long-term semaglutide treatment may cause GLP-1 receptor desensitization, and the agent lacks direct regulatory effects on adipose tissue and hepatic lipid metabolism. Clinically, many patients still have persistent moderate-to-severe fatty liver despite standardized semaglutide therapy, highlighting an unmet clinical need for optimized treatment.\n\nMazdutide is a novel dual GLP-1R\u002FGCGR agonist. GCGR is highly expressed in the liver and adipose tissues. Via GCGR activation, mazdutide directly inhibits hepatic lipogenesis, promotes hepatic fat decomposition and fatty acid oxidation, and improves adipose tissue browning and thermogenesis. Compared with single GLP-1RAs, mazdutide exerts more direct and comprehensive regulatory effects on hepatic and systemic lipid metabolism, making it a promising option for T2DM patients with residual moderate-to-severe fatty liver after semaglutide treatment.\n\nThis study is a multicenter, prospective, stratified randomized controlled design and enrolls T2DM patients with persistent moderate-to-severe NAFLD after receiving subcutaneous semaglutide 1.0 mg once weekly for ≥28 weeks. with 1:1 group allocation and concealed grouping. Eligible subjects are randomized into two groups without drug washout: the intervention group switches to mazdutide therapy, while the control group continues semaglutide treatment. All baseline concomitant medications for metabolic diseases remain stable throughout the study to avoid confounding factors.\n\nMazdutide is titrated per official instructions, initiating at 2 mg once weekly and escalating to a 4 mg once weekly maintenance dose based on patient tolerability and efficacy. All participants maintain their habitual diet and exercise routines with regular lifestyle supervision to ensure study stability. After the initial intervention phase, patients with \\\u003C30% reduction in hepatic fat content will receive a mazdutide dose increase to 6 mg once weekly. Meanwhile, the control group will cross over to mazdutide treatment, and all patients will enter the subsequent observational stage.\n\nThe primary endpoint is the change in hepatic fat content from baseline to study endpoint, measured by MRI-PDFF and liver elastography, to evaluate the efficacy of mazdutide on hepatic steatosis. Secondary endpoints include inter-group differences in glycemic control, body composition, islet function, liver enzymes and lipid profiles. The efficacy changes during the crossover period are also observed. All adverse events are recorded to assess the safety and tolerability of mazdutide in this patient population.",[30,561],"Nonalcoholic Fatty Liver Disease (NAFLD) With History of Diabetes Melitus",[256,563,564,565,566],"Nonalcoholic Fatty Liver Disease","Mazdutide","Randomized Controlled Trial","Liver Fat Content","2026-07-15",{"date":198,"type":45},{"date":288,"type":22},{"date":571,"type":22},"2028-02-01",{"name":573,"class":52},"Tianjin Medical University",{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":4,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":18,"minAge":96,"maxAge":4,"enrollmentInfo":581,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":589,"leadSponsor":590,"locationsCount":53},"100647462","preadmission-glp-1-receptor-agonist-plus-sglt2-inhibitor-use-and-early-outcomes-after-pneumonia-hospitalization-in-adults-with-type-2-diabetes-100647462","NCT07708610","Preadmission GLP-1 Receptor Agonist Plus SGLT2 Inhibitor Use and Early Outcomes After Pneumonia Hospitalization in Adults With Type 2 Diabetes","Preadmission GLP-1 Receptor Agonist Plus SGLT2 Inhibitor Use and Early Outcomes After Pneumonia Hospitalization in Adults With Type 2 Diabetes: A Target Trial Emulation","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Type 2 diabetes mellitus\n* Hospitalization with pneumonia during the study period, serving as the index admission\n* Prescription of a GLP-1 receptor agonist, an SGLT2 inhibitor, or usual-care glucose-lowering therapy in the year before the index admission\n* No GLP-1 receptor agonist or SGLT2 inhibitor prescription in the 6 months before the first qualifying prescription\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus, or other specified diabetes types that are not type 2 diabetes\n* Human immunodeficiency virus infection\n* Bariatric surgery\n* Solid-organ transplantation\n* Pneumonia hospitalization, invasive mechanical ventilation, or renal replacement therapy in the year before the index admission\n* End-stage kidney disease, dialysis dependence, ventilator dependence, or tracheostomy status\n* Metastatic malignancy, lung cancer, or palliative care\n* Viral pneumonia, influenza with pneumonia, or COVID-19 around the index admission\n* Acute cardiovascular event in the 6 months before the index admission",{"count":582,"type":22},71775,"This retrospective observational target-trial emulation uses electronic health record data from the TriNetX US Collaborative Network to compare preadmission glucose-lowering treatment strategies in adults with type 2 diabetes hospitalized with pneumonia. Time zero is the date of the index pneumonia admission. The study compares patients with evidence of prescriptions for both a GLP-1 receptor agonist and an SGLT2 inhibitor in the year before admission with patients prescribed a GLP-1 receptor agonist alone, an SGLT2 inhibitor alone, or usual care. Usual care includes metformin, sulfonylureas, or DPP-4 inhibitors without either study class. The primary outcome is a composite of all-cause death, invasive mechanical ventilation, or renal replacement therapy within 30 days of admission, with the individual components and 12-month mortality, major adverse cardiovascular events, and major adverse kidney events also evaluated. Propensity-score methods are used to reduce bias from nonrandom treatment selection.",[585,30],"Pneumonia","2026-07-13",{"date":541,"type":45},{"date":386,"type":22},{"date":47,"type":22},{"name":591,"class":52},"Chung Shan Medical University",{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":598,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":18,"minAge":96,"maxAge":250,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":606,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":53},"100584032","phase-1-time-restricted-eating-in-patients-with-microalbuminuria-100584032","NCT06884059","Time Restricted Eating in Patients With Microalbuminuria","Impact of Time-Restricted Eating (TRE) on Kidney Health (The TREK Study)","TREK","Inclusion Criteria:\n\n1. Age: 18-75 years old\n2. Participants with T2DM with A1c between 6.5 and 9.0 % and on stable doses of medications who are weight-bearing and self-ambulatory.\n3. uACR ( urine albumin creatinine ratio) results ≥ 30 - 300 mg.\n4. Willingness to use smartphone for research procedures (Apple iOS or Android OS)\n5. Baseline eating period ≥12 hours\u002Fday and sufficient logging on the mCC app.\n6. Person of childbearing potential will be given a pregnancy test on study enrollment and asked to use contraception throughout the study.\n7. Post-menopausal and individuals on hormone replacement therapy will be included.\n8. Estimated Glomerular Filtration Rate (EGFR) \\> 45\n9. If participants are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid-modifying drugs, anti-hypertensives) no dose adjustments will be allowed during the study period\n10. Participants on stable doses (consistent dose for ≥3 months) of GLP-1 receptor agonists will be included.\n\nExclusion Criteria:\n\n1. Participants with Type1DM and T2DM who are taking insulin, sulfonylureas, or have an HbA1c \\> 9 %.\n2. Estimated Glomerular Filtration Rate (EGFR) \\\u003C 45\n3. Systolic BP greater than 160 mmHg and\u002For Diastolic BP greater than 110 mmHg (with or without treatment\u002Fmedication)\n4. LDL cholesterol greater than 200 mg\u002FdL\n5. Triglycerides greater than 500 mg\u002FdL\n6. Active tobacco or illicit drug use\n7. Pregnant or breastfeeding individuals.\n8. Currently enrolled in a weight-loss or weight-management program,\n9. Currently on a special or prescribed diet for other reasons (e.g., Celiac disease),\n10. On recently prescribed medication that is meant for weight loss, or has known effect on appetite suppression ( patient on stable dose for 3 months can be enrolled ).\n11. History of eating disorder(s).\n12. History of surgical intervention for weight management (e) active eating disorder.\n13. Chronic kidney disease with an eGFR calculated based on the Modification of Diet in Renal Disease (MDRD) equation \\\u003C50mL\u002Fmin\u002F1.73m2\n14. Treatment for active inflammatory and\u002For rheumatologic disease and cancer.\n15. A major adverse cardiovascular event within the past 6 months such as acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke\u002Ftransient ischemic attack (TIA).\n16. History of Uncontrolled arrhythmia (i.e., rate-controlled atrial fibrillation\u002Fatrial flutter are not exclusion criteria) 18. Liver cirrhosis and\u002For significant alterations in liver function\n17. History of (a) thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion), Shift workers with variable (e.g., nocturnal) hours.\n18. Caregivers for dependents requiring frequent nocturnal care\u002Fsleep interruptions.\n19. More than one trip planned to travel to a time zone with greater than a 3-hour difference during study period.\n20. History of major adverse cardiovascular events within the past 1 year (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke\u002Ftransient ischemic attack (TIA)).\n21. History of thyroid disease requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e., hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion).\n22. History of adrenal disease.\n23. History of malignancy undergoing active treatment, except non-melanoma skin cancer.\n24. Known history of type I diabetes.\n25. History of stage 4 or 5 chronic kidney disease or requiring dialysis.\n26. History of HIV\u002FAIDS.\n27. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).",{"count":7,"type":22},[538],"This is a clinical trial to assess how time-restricted eating (TRE) may improve kidney health and filtration patients with type 2 diabetes and increased protein content in their urine. All participants will be participating in TRE in which they follow a consistent 8-10 hour eating window everyday.",[30,604,605],"Time Restricted Eating","Microalbuminuria",[605,604,607,308,608,609],"Urine Albumin-to-Creatinine Ratio","uACR","Fasting","2026-07-10",{"date":612,"type":45},"2026-07-14",{"date":614,"type":22},"2026-07",{"date":616,"type":22},"2028-02",{"name":618,"class":52},"University of California, San Diego",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":401,"sex":18,"minAge":96,"maxAge":626,"enrollmentInfo":627,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":629,"conditions":630,"keywords":632,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":640,"leadSponsor":641,"locationsCount":53},"100645716","salivary-apelin-chemerin-ghrelin-and-lipocalin-2-levels-in-diabetic-patients-with-periodontitis-100645716","NCT07703345","Salivary Apelin, Chemerin, Ghrelin, and Lipocalin-2 Levels in Diabetic Patients With Periodontitis","Evaluation of Salivary Apelin, Chemerin, Ghrelin and Lipocalin 2 Levels in Diabetic Patients With Periodontitis","Inclusion Criteria:\n\n* Individuals aged 18 to 80 years. Individuals who apply to the Department of Periodontology, Faculty of Dentistry, Necmettin Erbakan University.\n\nIndividuals who agree to participate in the study and sign the informed consent form.\n\nPresence of at least 20 teeth. For the periodontally healthy groups: diagnosis of periodontal health based on routine clinical and radiographic examination.\n\nFor the periodontitis groups: diagnosis of generalized Stage II or Stage III periodontitis based on routine clinical and radiographic examination according to the 2017 World Workshop Classification of Periodontal and Peri-Implant Diseases and Conditions.\n\nFor the type 2 diabetes mellitus groups: diagnosis of type 2 diabetes mellitus. For the systemically healthy groups: absence of systemic diseases, including type 2 diabetes mellitus.\n\nExclusion Criteria:\n\n* Periodontal treatment, including scaling and root surface debridement, within the last 6 months.\n\nAntibiotic use within the last 6 months. Pregnancy or lactation. Presence of autoimmune diseases such as rheumatoid arthritis, familial Mediterranean fever, ankylosing spondylitis, Behçet disease, or psoriasis.\n\nPresence of systemic diseases other than type 2 diabetes mellitus in the diabetes groups.\n\nPresence of systemic diseases such as nephrotic syndrome, chronic renal disease, or cardiovascular disease.\n\nSmoking 10 or more cigarettes per day.","80 Years",{"count":628,"type":22},88,"This observational cross-sectional study will evaluate salivary apelin, chemerin, ghrelin, and lipocalin-2 levels in individuals with different periodontal and systemic conditions. Participants will be divided into four groups according to periodontal status and the presence or absence of type 2 diabetes mellitus.\n\nClinical periodontal measurements and unstimulated saliva samples will be obtained before periodontal treatment. Salivary biomarker levels will be measured using enzyme-linked immunosorbent assay kits. The study aims to determine whether salivary apelin, chemerin, ghrelin, and lipocalin-2 levels are associated with periodontitis, type 2 diabetes mellitus, and periodontal clinical parameters.",[631,30],"Periodontitis",[631,256,633,634,635],"Salivary Biomarkers","Apelin","Chemerin","2026-07-09",{"date":612,"type":45},{"date":639,"type":45},"2026-07-01",{"date":360,"type":22},{"name":642,"class":52},"Necmettin Erbakan University",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":649,"eligibilityCriteria":650,"healthyVolunteers":12,"sex":18,"minAge":96,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":23,"phases":653,"briefSummary":654,"conditions":655,"keywords":657,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":53},"100584262","achieving-routine-intervention-and-screening-for-emotional-health-100584262","NCT06887049","Achieving Routine Intervention and Screening for Emotional Health","ARISE: Achieving Routine Intervention and Screening for Emotional Health: Randomized Controlled Trial","ARISE","Inclusion Criteria:\n\n* Patient at a participating clinic\n* Type 2 diabetes\n* Adult (18 years or older)\n* A1C \\> 8%\n\nExclusion Criteria:\n\n* Pregnant",{"count":652,"type":22},1250,[25],"The purpose of this project is to evaluate the effectiveness of diabetes distress screening and intervention on patients with type 2 diabetes mellitus (T2DM).",[30,656],"Diabetes Distress",[658],"diabetes distress screening","2026-07-07",{"date":661,"type":45},"2026-07-08",{"date":663,"type":45},"2026-03-10",{"date":665,"type":22},"2028-09",{"name":667,"class":52},"University of Chicago",{"id":669,"slug":670,"hasResults":12,"nctId":671,"briefTitle":672,"officialTitle":673,"acronym":674,"eligibilityCriteria":675,"healthyVolunteers":12,"sex":18,"minAge":96,"maxAge":124,"enrollmentInfo":676,"targetDuration":4,"studyType":23,"phases":678,"briefSummary":679,"conditions":680,"keywords":681,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":686,"startDateStruct":687,"completionDateStruct":689,"leadSponsor":691,"locationsCount":53},"100646433","phase-1-huc-msc-exosomes-for-t2dm---safety--efficacy-100646433","NCT07693036","hUC-MSC-Exosomes for T2DM - Safety & Efficacy","An Exploratory Clinical Study Assessing the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Adult Type 2 Diabetes Mellitus","HOPE-T2DM","Inclusion Criteria:\n\n1. Age 18-65 years, diagnosed with T2DM for ≥5 years (\\\u003C20 years).\n2. Regular diet and exercise control combined with the following intensive treatment regimens, with screening HbA1c remaining between 7.5% and 9.0% (FBG \\\u003C13.9mmol\u002FL):Stable dose of insulin (basal or premixed) (\\\u003C1.5u\u002Fkg·d) combined with ≥1 oral antidiabetic drug (OAD) (e.g., Metformin, SGLT2i) for ≥3 months; or Insulin combined with a GLP-1RA (maximum tolerated dose, ≤1mg Qw); or GLP-1RA (maximum tolerated dose, ≤1mg Qw) combined with ≥1 OAD for ≥3 months; or Stable dose of ≥3 OADs (must include Metformin) for ≥3 months.\n3. Fasting C-peptide ≥1.0 ng\u002FmL.\n4. Glutamic acid decarboxylase (GAD) antibody and Islet cell antibody (IAA) negative.\n5. Body Mass Index (BMI) 18.5-35 kg\u002Fm ².\n6. Subjects voluntarily participate in the study and sign the informed consent form.\n7. Female subjects of childbearing potential and non-sterilized male subjects must agree to use highly effective contraceptive methods during the study period and for 1 year following the final infusion.\n\nExclusion Criteria:\n\n1. Type 1 diabetes or other specific types of diabetes.\n2. Occurrence of severe hypoglycemia or diabetic ketoacidosis within the past 6 months.\n3. Severe cardiovascular\u002Fcerebrovascular diseases, hepatic or renal insufficiency (e.g., eGFR \\\u003C30 mL\u002Fmin·1.73m²).\n4. Active malignancy, coagulation disorders, immune system diseases.\n5. Pregnant or lactating women.\n6. Individuals with allergic constitution.\n7. Exclusion of subjects currently participating in other clinical trials.\n8. Subjects deemed unsuitable for participation by the investigator.",{"count":677,"type":22},66,[538,160],"The goal of this clinical trial is to Evaluate the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Adult Type 2 Diabetes Mellitus.",[30],[682,683,308,684,685],"MSC-Exosomes","Exosomes","Safety","Efficacy",{"date":636,"type":45},{"date":688,"type":45},"2026-06-05",{"date":690,"type":22},"2028-06-08",{"name":692,"class":52},"Peking University First Hospital",{"id":694,"slug":695,"hasResults":12,"nctId":696,"briefTitle":697,"officialTitle":698,"acronym":699,"eligibilityCriteria":700,"healthyVolunteers":12,"sex":18,"minAge":61,"maxAge":626,"enrollmentInfo":701,"targetDuration":4,"studyType":23,"phases":703,"briefSummary":704,"conditions":705,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":706,"lastUpdatePostDateStruct":707,"startDateStruct":709,"completionDateStruct":710,"leadSponsor":712,"locationsCount":53},"100646847","ai-assisted-antidiabetic-drug-consultation-system-for-glycemic-control-in-type-2-diabetes-patients-managed-by-non-specialist-physicians-100646847","NCT07684690","AI-Assisted Antidiabetic Drug Consultation System for Glycemic Control in Type 2 Diabetes Patients Managed by Non-Specialist Physicians","Clinical Validation of AI-assisted Antidiabetic Drug Consultation System-1","AI-ADCS","Inclusion Criteria:\n\n* Adults aged 18 to 80 years\n* Diagnosis of type 2 diabetes for at least 6 months\n* HbA1c above 8% within the past 3 months\n* Currently using one or more oral antidiabetic drugs\n* Able to understand and provide written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Recent participation in another interventional clinical trial\n* Cognitive impairment precluding understanding of the study\n* Active cancer treatment within the past 6 years\n* Use of systemic steroids",{"count":702,"type":22},400,[25],"This study tests whether an artificial intelligence (AI) tool can help doctors choose better diabetes medicines for their patients. Type 2 diabetes is very common, but there are far more patients than diabetes specialists, so many patients are treated by doctors who are not diabetes specialists. The researchers built an AI consultation system that gives doctors real-time suggestions and predictions about diabetes medicines while they are prescribing. The doctor always makes the final decision.\n\nIn this trial, patients with type 2 diabetes whose blood sugar is not well controlled will be placed by chance (randomly) into one of two groups. In one group, the doctor uses the AI system when deciding on diabetes medicines. In the other group, the doctor prescribes as usual, without the AI system. All medicines used are already approved in Taiwan and given at approved doses.\n\nThe study follows each patient for 12 months, with check-ups at the start and at 3, 6, 9, and 12 months. The main goal is to compare how much the patients' long-term blood sugar level (HbA1c) improves between the two groups after one year. The researchers also look at how many patients reach their blood sugar target, how often low blood sugar happens, and whether any side effects occur. The aim is to find out whether using the AI tool leads to better blood sugar control.",[30],"2026-06-29",{"date":708,"type":45},"2026-07-06",{"date":614,"type":22},{"date":711,"type":22},"2027-11",{"name":713,"class":52},"National Taiwan University Hospital"]