Obesity Type 2 Diabetes Mellitus
Conditions
Keywords
Type 2 diabetes mellitus, Obesity, Fecal microbiota transplantation, Calorie-restricted diet, Semaglutide
Brief summary
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.
Detailed description
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).
Interventions
BIOLOGICALFecal 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.
Semaglutide 1.0 mg subcutaneous injection once weekly
BEHAVIORALCalorie-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.
Sponsors
Eighth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in body weight | From enrollment to the end of treatment at 24 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of participants achieving ≥5% body weight reduction | From enrollment to the end of treatment at 24 weeks | 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. |
| Change in glycated hemoglobin (HbA1c) | Baseline, Week 12, and Week 24 | 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. |
| Change in fasting insulin | Baseline, Week 12, and Week 24 | 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. |
| Change in fasting plasma glucose | Baseline, Week 12, and Week 24 | 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. |
| Change in total cholesterol | Baseline, Week 12, and Week 24 | 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. |
| Change in low-density lipoprotein cholesterol | Baseline, Week 12, and Week 24 | 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. |
| Change in high-density lipoprotein cholesterol | Baseline, Week 12, and Week 24 | 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. |
| Change in triglycerides | Baseline, Week 12, and Week 24 | 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. |
| Change in uric acid | Baseline, Week 12, and Week 24 | 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. |
| Change in urinary albumin-to-creatinine ratio | Baseline, Week 12, and Week 24 | 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. |
| Change in high-sensitivity C-reactive protein | Baseline, Week 12, and Week 24 | 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. |
| Change in gut microbiota diversity indices | Baseline, Week 12, and Week 24 | 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. |
| Change in fecal short-chain fatty acid concentrations | Baseline, Week 12, and Week 24 | 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. |
| Change in systolic blood pressure | Baseline, Week 12, and Week 24 | 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. |
| Change in diastolic blood pressure | Baseline, Week 12, and Week 24 | 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. |
| Change in body mass index | Baseline, Week 12, and Week 24 | 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. |
| Change in waist circumference | Baseline, Week 12, and Week 24 | 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. |
| Change in muscle mass | Baseline, Week 12, and Week 24 | 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. |
| Change in body fat percentage | Baseline, Week 12, and Week 24 | 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. |
| Change in visceral fat area | Baseline, Week 12, and Week 24 | 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. |
Countries
China
Contacts
CONTACTYunfeng Shen, Ph.D
Outcome results
None listed