About this trial
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.
Eligibility criteria
Qualifiers
Age 18-60 years;
Body mass index (BMI) ≥30 kg/m² and <40 kg/m²;
Duration of type 2 diabetes mellitus <1 year;
Non-smoker or smoking cessation >3 months;
Disqualifiers
Complicated with severe hepatic or renal insufficiency (alanine aminotransferase/aspartate aminotransferase [ALT/AST] >3 times the upper limit of normal, or estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m²);
Inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other organic intestinal diseases; autoimmune diseases, malignancies, or active infections;
Medication and intervention exclusions: Use of α-glucosidase inhibitors, antibiotics, proton pump inhibitors (PPIs), or probiotics/prebiotics within the past 3 months; bariatric surgery within the past 6 months; long-term use of immunosuppressants or glucocorticoids;
Others: Pregnant or lactating women; currently participating in other clinical trials.
Trial design
Treatments tested in this trial
- Fecal microbiota transplantation (FMT)
- Semaglutide (1 Mg Dose)
- Calorie-restricted diet