Safety and Efficacy of Human Microbiota Transplantation for Overweight and Obese Type 2 Diabetes Mellitus ( SETOM ): A Randomized, Double-blind, Placebo-controlled Clinical Study
The main purpose is to evaluate whether the percentage of body weight change from baseline to week 12 is higher than that in the placebo group. In this randomized, double-blind, placebo-controlled study, 39 patients fulfilling the study criteria will be enrolled in the study. Patients will be randomized(2:1) to either FMT or placebo.
• A diagnosis of T2DM (≥2 months) according to the dagnostic and typing criteria of Chinese guideline for type 2 diabetes
• Control the blood glucose level through diet or exercise only and never receive any hypoglycemic agent in the last 8 weeks.
• Continuous treatment with insulin and its analogues for no more than 14 days in the last year. (The duration of treatment with insulin and its analogues for gestational diabetes mellitus is not included)
• 7.0%≤HbA1c≤10.0%
• Fasting plasma glucose(FPG)\<15mmol/L
• 24kg/m2≤BMI≤35kg/m2
• Give informed consent and agree to receive FMT
• Agree to maintain the same diet and exercise habit during the whole process.