Fecal Microbiota Transplantation (FMT) Combined With Calorie-Restricted Diet and Semaglutide in Patients With Obesity and Type 2 Diabetes

Официальное название

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

Обзор

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.

Подробное описание

This study is designed as a single-center, randomized, open-label, parallel-controlled trial. A total of 20 patients with moderate to severe obesity and T2DM (BMI 30-40 kg/m²) whose T2DM duration is less than one year will be enrolled, and randomly assigned to either the intervention group (FMT + ccalorie-restricted diet + semaglutide) or the control group (calorie-restricted diet + semaglutide). The intervention period will be 24 weeks. The primary endpoint is the percentage change in body weight from baseline to post-intervention. Secondary endpoints include the proportion of patients achieving a \>5% weight loss, as well as metabolic parameters such as fasting blood glucose, lipid profile, glycated hemoglobin, visceral fat parameters, and gut microbiota diversity (Shannon/Simpson index).

Вмешательства

• Биопрепарат Fecal microbiota transplantation (FMT)
  Donor Selection: Healthy lean donors with BMI \<23 kg/m² will be selected following rigorous health screening. Capsule Preparation: Donor fecal samples will be homogenized, filtered to remove debris, lyophilized, and encapsulated in enteric-coated capsules. Oral FMT capsule dosage: 10 capsules per dose, once daily, for 6 consecutive days each month.
• Препарат Semaglutide (1 Mg Dose)
  Semaglutide 1.0 mg subcutaneous injection once weekly
• Поведенческое Calorie-restricted diet
  Daily caloric intake will be individualized based on physical activity level: 25 kcal/kg/day for individuals with light-to-moderate physical activity and 30 kcal/kg/day for those with heavy physical activity.

Первичные конечные точки

• Percent change in body weight [Срок оценки: From enrollment to the end of treatment at 24 weeks]

Вторичные конечные точки (12)

• The proportion of participants achieving ≥5% body weight reduction [Срок оценки: From enrollment to the end of treatment at 24 weeks]
• Change in glycated hemoglobin (HbA1c) [Срок оценки: Baseline, Week 12, and Week 24]
• Change in fasting insulin [Срок оценки: Baseline, Week 12, and Week 24]
• Change in fasting plasma glucose [Срок оценки: Baseline, Week 12, and Week 24]
• Change in total cholesterol [Срок оценки: Baseline, Week 12, and Week 24]
• Change in low-density lipoprotein cholesterol [Срок оценки: Baseline, Week 12, and Week 24]
• Change in high-density lipoprotein cholesterol [Срок оценки: Baseline, Week 12, and Week 24]
• Change in triglycerides [Срок оценки: Baseline, Week 12, and Week 24]
• Change in uric acid [Срок оценки: Baseline, Week 12, and Week 24]
• Change in urinary albumin-to-creatinine ratio [Срок оценки: Baseline, Week 12, and Week 24]
• Change in high-sensitivity C-reactive protein [Срок оценки: Baseline, Week 12, and Week 24]
• Change in gut microbiota diversity indices [Срок оценки: Baseline, Week 12, and Week 24]

Критерии участия

Критерии включения

• 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;
• Voluntary signed informed consent with commitment to complete the entire study.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Eighth Affiliated Hospital, Sun Yat-sen University — Шэньчжэнь

Идентификаторы

NCT: NCT07599046 · 2025-183-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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