Fecal Microbiota Transplantation (FMT) Combined With Calorie-Restricted Diet and Semaglutide in Patients With Obesity and Type 2 Diabetes
13. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Detaillierte Beschreibung
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).
Studientyp
Interventionell
Einschreibung (Geschätzt)
20
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Yunfeng Shen, Ph.D
- Telefonnummer: 0755-83982222
- E-Mail: shenyf26@mail.sysu.edu.cn
Studienorte
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Guangdong
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Shenzhen, Guangdong, China, 518033
- Eighth Affiliated Hospital, Sun Yat-sen University
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Kontakt:
- Yunfeng Shen, Ph.D
- Telefonnummer: 0755-83982222
- E-Mail: shenyf26@mail.sysu.edu.cn
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Intervention group
A comprehensive intervention combining fecal microbiota transplantation, calorie-restricted diet, and glucagon-like peptide-1 receptor agonist.
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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.
Andere Namen:
Semaglutide 1.0 mg subcutaneous injection once weekly
Andere Namen:
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.
Andere Namen:
|
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Aktiver Komparator: Control group
Conventional treatment with calorie-restricted diet and glucagon-like peptide-1 receptor agonist.
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Semaglutide 1.0 mg subcutaneous injection once weekly
Andere Namen:
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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percent change in body weight
Zeitfenster: From enrollment to the end of treatment at 24 weeks
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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.
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From enrollment to the end of treatment at 24 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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The proportion of participants achieving ≥5% body weight reduction
Zeitfenster: From enrollment to the end of treatment at 24 weeks
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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.
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From enrollment to the end of treatment at 24 weeks
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Change in glycated hemoglobin (HbA1c)
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in fasting insulin
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in fasting plasma glucose
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in total cholesterol
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in low-density lipoprotein cholesterol
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in high-density lipoprotein cholesterol
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in triglycerides
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in uric acid
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in urinary albumin-to-creatinine ratio
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in high-sensitivity C-reactive protein
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in gut microbiota diversity indices
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in fecal short-chain fatty acid concentrations
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in systolic blood pressure
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in diastolic blood pressure
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in body mass index
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in waist circumference
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in muscle mass
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in body fat percentage
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Change in visceral fat area
Zeitfenster: Baseline, Week 12, and Week 24
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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.
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Baseline, Week 12, and Week 24
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
30. April 2026
Primärer Abschluss (Geschätzt)
30. Januar 2027
Studienabschluss (Geschätzt)
30. Dezember 2029
Studienanmeldedaten
Zuerst eingereicht
9. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. Mai 2026
Zuerst gepostet (Tatsächlich)
20. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
13. Mai 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des endokrinen Systems
- Ernährungsstörungen
- Stoffwechselerkrankungen
- Überernährung
- Körpergewicht
- Störungen des Glukosestoffwechsels
- Diabetes Mellitus
- Übergewicht
- Pathologische Zustände, Anzeichen und Symptome
- Ernährungs- und Stoffwechselerkrankungen
- Anzeichen und Symptome
- Fettleibigkeit
- Diabetes mellitus, Typ 2
- Therapeutika
- Ernährung, Nahrung und Ernährung
- Physiologische Phänomene
- Ernährung physiologische Phänomene
- Diättherapie
- Ernährungstherapie
- Diät
- Biologische Therapie
- Energieaufnahme
- Semaglutid
- Fäkalmikrobiota -Transplantation
- Kalorienbeschränkung
Andere Studien-ID-Nummern
- 2025-183-02
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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