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

N/ANot Yet RecruitingNCT07599046

Eighth Affiliated Hospital, Sun Yat-sen University20 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity Type 2 Diabetes Mellitus

Interventions

Fecal microbiota transplantation (FMT)BIOLOGICAL

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.

Semaglutide (1 Mg Dose)DRUG

Semaglutide 1.0 mg subcutaneous injection once weekly

Calorie-restricted dietBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18-60 years; 2. Body mass index (BMI) ≥30 kg/m² and \<40 kg/m²; 3. Duration of type 2 diabetes mellitus \<1 year; 4. Non-smoker or smoking cessation \>3 months; 5. Voluntary signed informed consent with commitment to complete the entire study. Exclusion Criteria: 1. 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); 2. Inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other organic intestinal diseases; autoimmune diseases, malignancies, or active infections; 3. 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; 4. Others: Pregnant or lactating women; currently participating in other clinical trials.

Locations (1)

Eighth Affiliated Hospital, Sun Yat-sen University

Shenzhen, Guangdong, China

Outcomes

Primary Outcomes

Percent change in body weight

The percentage change in body weight from baseline to follow-up visit (week 24) is presented. Body weight (kg) will be measured using a calibrated electronic scale operated by research personnel who have undergone standardized training.

Time frame: From enrollment to the end of treatment at 24 weeks

Secondary Outcomes

The proportion of participants achieving ≥5% body weight reduction

The percentage of participants who achieved ≥5% weight reduction from baseline to follow-up visit (week 24) is presented. Body weight (kg) will be measured using a calibrated electronic scale operated by research personnel who have undergone standardized training.

Time frame: From enrollment to the end of treatment at 24 weeks

Change in glycated hemoglobin (HbA1c)

Change in glycated hemoglobin (HbA1c) from baseline to week 12 and week 24 is presented. HbA1c (%) values will be retrieved from the hospital's electronic medical record system.

Time frame: Baseline, Week 12, and Week 24

Change in fasting insulin

Change in fasting insulin from baseline to week 12 and week 24 is presented. Fasting insulin (μU/mL) values will be retrieved from the hospital's electronic medical record system.

Time frame: Baseline, Week 12, and Week 24

Change in fasting plasma glucose

Change in fasting plasma glucose from baseline to week 12 and week 24 is presented. Fasting plasma glucose (mmol/L) values will be retrieved from the hospital's electronic medical record system.

Time frame: Baseline, Week 12, and Week 24

Change in total cholesterol

Change in total cholesterol from baseline to week 12 and week 24 is presented. Total cholesterol (mmol/L) values will be retrieved from the hospital's electronic medical record system.

Central Contacts

Yunfeng Shen, Ph.D

CONTACT

0755-83982222 shenyf26@mail.sysu.edu.cn

Data from ClinicalTrials.gov

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Time frame: Baseline, Week 12, and Week 24

Change in low-density lipoprotein cholesterol

Change in low-density lipoprotein cholesterol from baseline to week 12 and week 24 is presented. Low-density lipoprotein cholesterol (mmol/L) will be retrieved from the hospital's electronic medical record system.

Time frame: Baseline, Week 12, and Week 24

Change in high-density lipoprotein cholesterol

Change in high-density lipoprotein cholesterol from baseline to week 12 and week 24 is presented. High-density lipoprotein cholesterol (mmol/L) will be retrieved from the hospital's electronic medical record system.

Time frame: Baseline, Week 12, and Week 24

Change in triglycerides

Change in triglycerides from baseline to week 12 and week 24 is presented. Triglycerides (mmol/L) values will be retrieved from the hospital's electronic medical record system.

Time frame: Baseline, Week 12, and Week 24

Change in uric acid

Change in uric acid from baseline to week 12 and week 24 is presented. Uric acid (μmol/L) values will be retrieved from the hospital's electronic medical record system.

Time frame: Baseline, Week 12, and Week 24

Change in urinary albumin-to-creatinine ratio

Change in urinary albumin-to-creatinine ratio from baseline to week 12 and week 24 is presented. The albumin-to-creatinine ratio is defined as urinary albumin (mg) divided by urinary creatinine (g). Albumin-to-creatinine ratio (mg/g) values will be retrieved from the hospital's electronic medical record system.

Time frame: Baseline, Week 12, and Week 24

Change in high-sensitivity C-reactive protein

Change in high-sensitivity C-reactive protein from baseline to week 12 and week 24 is presented. High-sensitivity C-reactive protein (mg/dL) values will be retrieved from the hospital's electronic medical record system.

Time frame: Baseline, Week 12, and Week 24

Change in gut microbiota diversity indices

Change in gut microbiota diversity indices (such as Shannon diversity index and Simpson diversity index) from baseline to week 12 and week 24 is presented. The gut microbiota diversity indices will be derived from metagenomic sequencing data.

Time frame: Baseline, Week 12, and Week 24

Change in fecal short-chain fatty acid concentrations

Change in fecal short-chain fatty acid concentrations from baseline to week 12 and week 24 is presented. Fecal short-chain fatty acid concentrations (µmol/g wet feces) will be measured by gas chromatography.

Time frame: Baseline, Week 12, and Week 24

Change in systolic blood pressure

Change in systolic blood pressure from baseline to week 12 and week 24 is presented. Systolic blood pressure (mmHg) values will be retrieved from the hospital's electronic medical record system.

Time frame: Baseline, Week 12, and Week 24

Change in diastolic blood pressure

Change in diastolic blood pressure from baseline to week 12 and week 24 is presented. Diastolic blood pressure (mmHg) values will be retrieved from the hospital's electronic medical record system.

Time frame: Baseline, Week 12, and Week 24

Change in body mass index

Change in body mass index (BMI) from baseline to week 12 and week 24 is presented. BMI is calculated using the formula: BMI = weight (kg) / \[height (m)\]². Height and weight will be measured using a stadiometer and calibrated electronic scale, respectively, operated by research personnel who have undergone standardized training.

Time frame: Baseline, Week 12, and Week 24

Change in waist circumference

Change in waist circumference from baseline to week 12 and week 24 is presented. Waist circumference (cm) will be measured using a non-elastic measuring tape operated by research personnel who have undergone standardized training.

Time frame: Baseline, Week 12, and Week 24

Change in muscle mass

Change in muscle mass from baseline to week 12 and week 24 is presented. Muscle mass (kg) will be measured using an InBody body composition analyzer operated by research personnel who have undergone standardized training.

Time frame: Baseline, Week 12, and Week 24

Change in body fat percentage

Change in body fat percentage from baseline to week 12 and week 24 is presented. Body fat percentage (%) will be measured using an InBody body composition analyzer operated by research personnel who have undergone standardized training.

Time frame: Baseline, Week 12, and Week 24

Change in visceral fat area

Change in visceral fat area from baseline to week 12 and week 24 is presented. Visceral fat area (cm²) will be measured using a bioelectrical impedance analyzer operated by research personnel who have undergone standardized training.

Time frame: Baseline, Week 12, and Week 24