[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638925":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":44,"centralContacts":45,"locations":51,"responsibleParty":66,"collaborators":44,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":44,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":44,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":92,"whyStopped":44,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Eighth Affiliated Hospital, Sun Yat-sen University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","A comprehensive intervention combining fecal microbiota transplantation, calorie-restricted diet, and glucagon-like peptide-1 receptor agonist.",[13,14,15],"Biological: Fecal microbiota transplantation (FMT)","Drug: Semaglutide (1 Mg Dose)","Behavioral: Calorie-restricted diet",{"label":17,"type":18,"description":19,"interventionNames":20},"Control group","ACTIVE_COMPARATOR","Conventional treatment with calorie-restricted diet and glucagon-like peptide-1 receptor agonist.",[14,15],[22,29,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","Fecal microbiota transplantation (FMT)","Donor Selection: Healthy lean donors with BMI \\\u003C23 kg\u002Fm² will be selected following rigorous health screening.\n\nCapsule Preparation: Donor fecal samples will be homogenized, filtered to remove debris, lyophilized, and encapsulated in enteric-coated capsules.\n\nOral FMT capsule dosage: 10 capsules per dose, once daily, for 6 consecutive days each month.",[9],[28],"FMT",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Semaglutide (1 Mg Dose)","Semaglutide 1.0 mg subcutaneous injection once weekly",[17,9],[35,36],"glucagon-like peptide-1 receptor agonist","GLP-1 receptor agonist",{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"BEHAVIORAL","Calorie-restricted diet","Daily caloric intake will be individualized based on physical activity level: 25 kcal\u002Fkg\u002Fday for individuals with light-to-moderate physical activity and 30 kcal\u002Fkg\u002Fday for those with heavy physical activity.",[17,9],[43],"CRD",null,[46],{"name":47,"role":48,"phone":49,"phoneExt":44,"email":50},"Yunfeng Shen, Ph.D","CONTACT","0755-83982222","shenyf26@mail.sysu.edu.cn",[52],{"facility":5,"status":44,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Shenzhen","Guangdong","518033","China","CN",{"type":59,"coordinates":60},"Point",[61,62],114.0683,22.54554,{"lat":62,"lon":61},[65],{"name":47,"role":48,"phone":49,"phoneExt":44,"email":50},{"type":67,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100638925","fecal-microbiota-transplantation-fmt-combined-with-calorie-restricted-diet-and-semaglutide-in-patients-with-obesity-and-type-2-diabetes-100638925",false,"NCT07599046","Fecal Microbiota Transplantation (FMT) Combined With Calorie-Restricted Diet and Semaglutide in Patients With Obesity and Type 2 Diabetes","Effects of Comprehensive Intervention With Fecal Microbiota Transplantation Versus Conventional Treatment on Body Weight and Metabolism in Patients With Obesity Complicated by Type 2 Diabetes Mellitus: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age 18-60 years;\n2. Body mass index (BMI) ≥30 kg\u002Fm² and \\\u003C40 kg\u002Fm²;\n3. Duration of type 2 diabetes mellitus \\\u003C1 year;\n4. Non-smoker or smoking cessation \\>3 months;\n5. Voluntary signed informed consent with commitment to complete the entire study.\n\nExclusion Criteria:\n\n1. Complicated with severe hepatic or renal insufficiency (alanine aminotransferase\u002Faspartate aminotransferase \\[ALT\u002FAST\\] \\>3 times the upper limit of normal, or estimated glomerular filtration rate \\[eGFR\\] \\\u003C60 mL\u002Fmin\u002F1.73 m²);\n2. Inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other organic intestinal diseases; autoimmune diseases, malignancies, or active infections;\n3. Medication and intervention exclusions: Use of α-glucosidase inhibitors, antibiotics, proton pump inhibitors (PPIs), or probiotics\u002Fprebiotics within the past 3 months; bariatric surgery within the past 6 months; long-term use of immunosuppressants or glucocorticoids;\n4. Others: Pregnant or lactating women; currently participating in other clinical trials.","ALL","18 Years","60 Years",{"count":79,"type":80},20,"ESTIMATED","INTERVENTIONAL",[83],"NA","Investigation of the efficacy of fecal microbiota transplantation added to calorie-restricted diet and semaglutide versus calorie-restricted diet and semaglutide alone for weight loss and metabolic improvement in patients with moderate to severe obesity and type 2 diabetes mellitus.",[86],"Obesity Type 2 Diabetes Mellitus",[88,89,90,39,91],"Type 2 diabetes mellitus","Obesity","Fecal microbiota transplantation","Semaglutide","NOT_YET_RECRUITING","2026-05-13",{"date":95,"type":96},"2026-05-20","ACTUAL",{"date":98,"type":80},"2026-04-30",{"date":100,"type":80},"2029-12-30",{"name":5,"class":6},1]