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

13. mai 2026 oppdatert av: Eighth Affiliated Hospital, Sun Yat-sen University

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Shenzhen, Guangdong, Kina, 518033
        • Eighth Affiliated Hospital, Sun Yat-sen University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention group
A comprehensive intervention combining fecal microbiota transplantation, calorie-restricted diet, and glucagon-like peptide-1 receptor agonist.
Biologisk: Fecal 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.

Andre navn:
  • FMT
Legemiddel: Semaglutide (1 Mg Dose)
Semaglutide 1.0 mg subcutaneous injection once weekly
Andre navn:
  • GLP-1 reseptoragonist
  • glucagon-like peptide-1 receptor agonist
Atferdsmessig: Calorie-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.
Andre navn:
  • CRD
Aktiv komparator: Control group
Conventional treatment with calorie-restricted diet and glucagon-like peptide-1 receptor agonist.
Legemiddel: Semaglutide (1 Mg Dose)
Semaglutide 1.0 mg subcutaneous injection once weekly
Andre navn:
  • GLP-1 reseptoragonist
  • glucagon-like peptide-1 receptor agonist
Atferdsmessig: Calorie-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.
Andre navn:
  • CRD

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent change in body weight
Tidsramme: 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.
From enrollment to the end of treatment at 24 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The proportion of participants achieving ≥5% body weight reduction
Tidsramme: 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.
From enrollment to the end of treatment at 24 weeks
Change in glycated hemoglobin (HbA1c)
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in fasting insulin
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in fasting plasma glucose
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in total cholesterol
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in low-density lipoprotein cholesterol
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in high-density lipoprotein cholesterol
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in triglycerides
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in uric acid
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in urinary albumin-to-creatinine ratio
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in high-sensitivity C-reactive protein
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in gut microbiota diversity indices
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in fecal short-chain fatty acid concentrations
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in systolic blood pressure
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in diastolic blood pressure
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in body mass index
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in waist circumference
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in muscle mass
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in body fat percentage
Tidsramme: 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.
Baseline, Week 12, and Week 24
Change in visceral fat area
Tidsramme: 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.
Baseline, Week 12, and Week 24

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eighth Affiliated Hospital, Sun Yat-sen University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. april 2026

Primær fullføring (Antatt)

30. januar 2027

Studiet fullført (Antatt)

30. desember 2029

Datoer for studieregistrering

Først innsendt

9. april 2026

Først innsendt som oppfylte QC-kriteriene

13. mai 2026

Først lagt ut (Faktiske)

20. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-183-02

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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