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

13. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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).

Typ studie

Intervenční

Zápis (Odhadovaný)

20

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
    • Guangdong
      • Shenzhen, Guangdong, Čína, 518033
        • Eighth Affiliated Hospital, Sun Yat-sen University
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Intervention group
A comprehensive intervention combining fecal microbiota transplantation, calorie-restricted diet, and glucagon-like peptide-1 receptor agonist.
Biologický: 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.

Ostatní jména:
  • FMT
Lék: Semaglutide (1 Mg Dose)
Semaglutide 1.0 mg subcutaneous injection once weekly
Ostatní jména:
  • Agonista receptoru GLP-1
  • glucagon-like peptide-1 receptor agonist
Behaviorální: 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.
Ostatní jména:
  • CRD
Aktivní komparátor: Control group
Conventional treatment with calorie-restricted diet and glucagon-like peptide-1 receptor agonist.
Lék: Semaglutide (1 Mg Dose)
Semaglutide 1.0 mg subcutaneous injection once weekly
Ostatní jména:
  • Agonista receptoru GLP-1
  • glucagon-like peptide-1 receptor agonist
Behaviorální: 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.
Ostatní jména:
  • CRD

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Percent change in body weight
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The proportion of participants achieving ≥5% body weight reduction
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Eighth Affiliated Hospital, Sun Yat-sen University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

30. dubna 2026

Primární dokončení (Odhadovaný)

30. ledna 2027

Dokončení studie (Odhadovaný)

30. prosince 2029

Termíny zápisu do studia

První předloženo

9. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

13. května 2026

První zveřejněno (Aktuální)

20. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. května 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2025-183-02

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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