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NCT Number: NCT07599046

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

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.

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Key information

Conditions

Obesity Type 2 Diabetes Mellitus Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eighth Affiliated Hospital, Sun Yat-sen University

Shenzhen, Guangdong, 518033, China

Location contact

Yunfeng Shen, Ph.D

CONTACT

[email protected]

0755-83982222

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: FMT

Semaglutide (1 Mg Dose)

Drug

Semaglutide 1.0 mg subcutaneous injection once weekly

Other names: glucagon-like peptide-1 receptor agonist, GLP-1 receptor agonist

Calorie-restricted diet

Behavioral

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.

Other names: CRD

Primary outcomes

  1. Percent change in body weight

    Time frame: 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 outcomes

  1. The proportion of participants achieving ≥5% body weight reduction

    Time frame: 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.

  2. Change in glycated hemoglobin (HbA1c)

    Time frame: 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.

  3. Change in fasting insulin

    Time frame: 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.

  4. Change in fasting plasma glucose

    Time frame: 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.

  5. Change in total cholesterol

    Time frame: 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.

  6. Change in low-density lipoprotein cholesterol

    Time frame: 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.

  7. Change in high-density lipoprotein cholesterol

    Time frame: 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.

  8. Change in triglycerides

    Time frame: 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.

  9. Change in uric acid

    Time frame: 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.

  10. Change in urinary albumin-to-creatinine ratio

    Time frame: 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.

  11. Change in high-sensitivity C-reactive protein

    Time frame: 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.

  12. Change in gut microbiota diversity indices

    Time frame: 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.

  13. Change in fecal short-chain fatty acid concentrations

    Time frame: 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.

  14. Change in systolic blood pressure

    Time frame: 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.

  15. Change in diastolic blood pressure

    Time frame: 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.

  16. Change in body mass index

    Time frame: 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.

  17. Change in waist circumference

    Time frame: 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.

  18. Change in muscle mass

    Time frame: 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.

  19. Change in body fat percentage

    Time frame: 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.

  20. Change in visceral fat area

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yunfeng Shen, Ph.D

CONTACT

[email protected]

0755-83982222

Sponsors and collaborators

Lead sponsor

Eighth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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