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← All trials/NCT07599046

Not yet recruitingPhase NA

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

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

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

20

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥30

Primary endpoint

•Body weight, % change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07599046
Org study ID2025-183-02

Timeline

Milestones

Study start2026-04-30estimated
Study first posted2026-05-20actual
Last update posted2026-05-20actual
Primary completion2027-01-30estimated
Study completion2029-12-30estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age60 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
7
Cardiometabolic biomarkers
7
Glycemic / diabetes
3
Other (unclassified)
3
Renal / kidney
1

Weight & body composition

7 endpoints
Primary/protocol endpoint

Percent change in body weight

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

The proportion of participants achieving ≥5% body weight reduction

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

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in body mass index

Time frame:Baseline, Week 12, and Week 24

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:Baseline, Week 12, and Week 24

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in muscle mass

Time frame:Baseline, Week 12, and Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in body fat percentage

Time frame:Baseline, Week 12, and Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in visceral fat area

Time frame:Baseline, Week 12, and Week 24

Visceral fat, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change in glycated hemoglobin (HbA1c)

Time frame:Baseline, Week 12, and Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Change in fasting insulin

Time frame:Baseline, Week 12, and Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change in fasting plasma glucose

Time frame:Baseline, Week 12, and Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Change in urinary albumin-to-creatinine ratio

Time frame:Baseline, Week 12, and Week 24

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

7 endpoints
Secondary/protocol endpoint

Change in total cholesterol

Time frame:Baseline, Week 12, and Week 24

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in low-density lipoprotein cholesterol

Time frame:Baseline, Week 12, and Week 24

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in high-density lipoprotein cholesterol

Time frame:Baseline, Week 12, and Week 24

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in triglycerides

Time frame:Baseline, Week 12, and Week 24

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in high-sensitivity C-reactive protein

Time frame:Baseline, Week 12, and Week 24

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:Baseline, Week 12, and Week 24

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure

Time frame:Baseline, Week 12, and Week 24

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Change in uric acid

Time frame:Baseline, Week 12, and Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in gut microbiota diversity indices

Time frame:Baseline, Week 12, and Week 24

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in fecal short-chain fatty acid concentrations

Time frame:Baseline, Week 12, and Week 24

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.