[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550060":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":53,"collaborators":26,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":82,"whyStopped":26,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Shanghai Municipal Hospital of Traditional Chinese Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LCD Group","ACTIVE_COMPARATOR","Participants will receive a Low-Calorie Diet (815-835 kcal\u002Fday; approximately 43% carbohydrate, 29% protein, and 29% fat) meals for 12 weeks, followed by a gradual food reintroduction phase combined with physical activity support for 12 weeks.",[13],"Combination Product: Low-Calorie Diet",{"label":15,"type":16,"description":17,"interventionNames":18},"LCMD Group","EXPERIMENTAL","Participants will receive a Low-Calorie Medicine Diet (815-835 kcal\u002Fday; approximately 43% carbohydrate, 29% protein, and 29% fat) meals product for 12 weeks, followed by a gradual food reintroduction phase combined with physical activity support for 12 weeks.",[19],"Combination Product: Low-Calorie Medicine Diet",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Low-Calorie Medicine Diet","Low-Calorie Medicine Diet meals which are 815-835 kcal\u002Fday (approximately 43% carbohydrate, 29% protein, and 29% fat), combined with physical activity.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Low-Calorie Diet","Low-Calorie Diet meals which are 815-835 kcal\u002Fday (approximately 43% carbohydrate, 29% protein, and 29% fat), combined with physical activity.",[9],[32],{"name":33,"affiliation":5,"role":34},"Feng Tao, M.D.","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+86 (021) 56639828","taofeng@shutcm.edu.cn",[41],{"facility":5,"status":26,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":26},"Shanghai","Shanghai Municipality","200074","China","CN",{"type":48,"coordinates":49},"Point",[50,51],121.45806,31.22222,{"lat":51,"lon":50},{"type":34,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Feng Tao","Director of Endocrinology","100550060","lcmd-for-type-2-diabetes-remission-evaluation-of-effectiveness-and-exploration-of-individual-differences-100550060",false,"NCT06442150","LCMD for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences","Low-Calorie Medicinal Diet for Type 2 Diabetes Remission: Evaluation of Effectiveness and Exploration of Individual Differences","LCMD","Inclusion Criteria:\n\n* Physician-diagnosed T2DM\n* The history of T2DM less than 6 years\n* Most recent HbA1c higher than 6.5%\n* Body mass index: 24-45 kg\u002Fm2\n* Fasting C-p ≥1.1 ng\u002Fml\n* Inability to provide informed consent\n\nExclusion Criteria:\n\n* Type 1 diabetes, type 2 diabetes currently treated with insulin, or HbA1c ≥12%\n* Cardiovascular events within 6 months before trial\n* Current use of anti-obesity medications, eating disorders, dieting behaviors, or weight loss \\>5 kg within 6 months before trial\n* Chronic kidney disease stage 3b or above (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²)\n* Any condition causing fluid overload, such as heart failure or liver cirrhosis\n* Previously diagnosed psychiatric disorders (e.g., schizophrenia, post-traumatic stress disorder, obsessive-compulsive disorder), uncontrolled depression, or epilepsy\n* Severe arthritis or active gout\n* Active gallstone disease or known as asymptomatic gallstones\n* Concurrent enrollment in another clinical trial\n* Pregnancy, lactation, or planned conception during the study\n* Substance abuse\n* Known malignancy\n* Comorbidities increasing dietary intervention risk (e.g., biliary disorders)\n* Long-term use of antibiotics, corticosteroids, NSAIDs, or PPIs\n* Chronic gastrointestinal disorders affecting gut microbiota (e.g., ulcerative colitis)\n* Severe hepatic impairment (ALT \\>2.5× ULN)\n* Inability to provide informed consent","ALL","18 Years","60 Years",{"count":68,"type":69},170,"ESTIMATED","INTERVENTIONAL",[72],"NA","Type 2 diabetes (T2DM) has become a major public health problem. Achieving remission (HbA1c\\\u003C6.5% without glucose-lowering medications) has recently become a new treatment goal. Low-calorie diets effectively induce remission, but adverse effects like fatigue, appetite, and constipation hinder success. Integrating traditional Chinese medicine (TCM) herbs into a low-calorie diet may alleviate adverse effects and improve remission rates.\n\nThis project investigates the efficacy of a Low-Calorie Medicine Diet (LCMD) in achieving T2DM remission among overweight\u002Fobese individuals through a randomized controlled trial. The investigators will explore individual differences in remission and elucidate the underlying biological mechanisms, focusing on the brain-gut-microbiota axis. By integrating nutrition and TCM dietetics, this project provides a novel, evidence-based approach to managing T2DM in Chinese populations.",[75,76],"Type 2 Diabetes Mellitus in Obese","Type 2 Diabetes",[78,79,80,81],"Remission of type 2 diabetes","Low Calorie Diet","Medicined Diet","Brain-Gut-Microbiome axis","NOT_YET_RECRUITING","2024-05-29",{"date":85,"type":86},"2024-06-04","ACTUAL",{"date":88,"type":69},"2024-06-01",{"date":90,"type":69},"2027-11-30",{"name":5,"class":6},1]