Obesity Type 2 Diabetes MellitusNCT07599046
Fecal Microbiota Transplantation (FMT) Combined With Calorie-Restricted Diet and Semaglutide in Patients With Obesity and Type 2 Diabetes
A study testing Fecal microbiota transplantation (FMT), Semaglutide (1 Mg Dose) and Calorie-restricted diet in people with Obesity Type 2 Diabetes Mellitus, run by Eighth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity Type 2 Diabetes Mellitus
- What is being tested?
- Fecal microbiota transplantation (FMT), Semaglutide (1 Mg Dose) and Calorie-restricted diet
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, 518033
Yunfeng Shen, Ph.D, 0755-83982222, shenyf26@mail.sysu.edu.cn
About this study
Official 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
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.
Read the 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).
- Conditions
- Obesity Type 2 Diabetes Mellitus
- Being tested
- Fecal microbiota transplantation (FMT), Semaglutide (1 Mg Dose), Calorie-restricted diet
- Keywords
- Type 2 diabetes mellitus, Obesity, Fecal microbiota transplantation, Calorie-restricted diet, Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT)Biological
Also called 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 Mg Dose)Drug
Also called glucagon-like peptide-1 receptor agonist, GLP-1 receptor agonist
Semaglutide 1.0 mg subcutaneous injection once weekly
Calorie-restricted dietBehavioural
Also called CRD
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | A comprehensive intervention combining fecal microbiota transplantation, calorie-restricted diet, and glucagon-like peptide-1 receptor agonist. Receives: Biological: Fecal microbiota transplantation (FMT); Drug: Semaglutide (1 Mg Dose); Behavioral: Calorie-restricted diet |
| Control group | Active comparator | Conventional treatment with calorie-restricted diet and glucagon-like peptide-1 receptor agonist. Receives: Drug: Semaglutide (1 Mg Dose); Behavioral: Calorie-restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12, and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599046
- Sponsor's protocol ID
- 2025-183-02
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07599046
- Acronym / sponsor ID
- 2025-183-02
- Conditions
- Obesity Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, Obesity, Fecal microbiota transplantation, Calorie-restricted diet, Semaglutide
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Biological: Fecal microbiota transplantation (FMT), Drug: Semaglutide (1 Mg Dose), Behavioral: Calorie-restricted dietA comprehensive intervention combining fecal microbiota transplantation, calorie-restricted diet, and glucagon-like peptide-1 receptor agonist. |
| Control group | Active comparator | Drug: Semaglutide (1 Mg Dose), Behavioral: Calorie-restricted dietConventional treatment with calorie-restricted diet and glucagon-like peptide-1 receptor agonist. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantation (FMT)Also: FMTDonor 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. | Biological | Intervention group |
| Semaglutide (1 Mg Dose)Also: glucagon-like peptide-1 receptor agonist, GLP-1 receptor agonistSemaglutide 1.0 mg subcutaneous injection once weekly | Drug | Control group, Intervention group |
| Calorie-restricted dietAlso: CRDDaily 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. | Behavioural | Control group, Intervention group |
Primary outcome
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.
20 secondary outcomes
The proportion of participants achieving ≥5% body weight reduction
Time frame: From enrollment to the end of treatment at 24 weeks
Change in glycated hemoglobin (HbA1c)
Time frame: Baseline, Week 12, and Week 24
Change in fasting insulin
Time frame: Baseline, Week 12, and Week 24
Change in fasting plasma glucose
Time frame: Baseline, Week 12, and Week 24
Change in total cholesterol
Time frame: Baseline, Week 12, and Week 24
Change in low-density lipoprotein cholesterol
Time frame: Baseline, Week 12, and Week 24
Change in high-density lipoprotein cholesterol
Time frame: Baseline, Week 12, and Week 24
Change in triglycerides
Time frame: Baseline, Week 12, and Week 24
Change in uric acid
Time frame: Baseline, Week 12, and Week 24
Change in urinary albumin-to-creatinine ratio
Time frame: Baseline, Week 12, and Week 24
Change in high-sensitivity C-reactive protein
Time frame: Baseline, Week 12, and Week 24
Change in gut microbiota diversity indices
Time frame: Baseline, Week 12, and Week 24
Change in fecal short-chain fatty acid concentrations
Time frame: Baseline, Week 12, and Week 24
Change in systolic blood pressure
Time frame: Baseline, Week 12, and Week 24
Change in diastolic blood pressure
Time frame: Baseline, Week 12, and Week 24
Change in body mass index
Time frame: Baseline, Week 12, and Week 24
Change in waist circumference
Time frame: Baseline, Week 12, and Week 24
Change in muscle mass
Time frame: Baseline, Week 12, and Week 24
Change in body fat percentage
Time frame: Baseline, Week 12, and Week 24
Change in visceral fat area
Time frame: Baseline, Week 12, and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation (FMT), Semaglutide (1 Mg Dose) and Calorie-restricted diet in people with Obesity Type 2 Diabetes Mellitus, run by Eighth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunfeng Shen, Ph.D (0755-83982222, shenyf26@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in body weight (time frame: From enrollment to the end of treatment at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.