Fecal Microbiota Transplantation (FMT) Combined With Calorie-Restricted Diet and Semaglutide in Patients With Obesity and Type 2 Diabetes
2026年5月13日 更新者：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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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).
研究の種類
介入
入学 (推定)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yunfeng Shen, Ph.D
- 電話番号：0755-83982222
- メール：shenyf26@mail.sysu.edu.cn
研究場所
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Guangdong
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Shenzhen、Guangdong、中国、518033
- Eighth Affiliated Hospital, Sun Yat-sen University
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コンタクト：
- Yunfeng Shen, Ph.D
- 電話番号：0755-83982222
- メール：shenyf26@mail.sysu.edu.cn
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
Semaglutide 1.0 mg subcutaneous injection once weekly
他の名前：
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.
他の名前：
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アクティブコンパレータ：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
他の名前：
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percent change in body weight
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The proportion of participants achieving ≥5% body weight reduction
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年4月30日
一次修了 (推定)
2027年1月30日
研究の完了 (推定)
2029年12月30日
試験登録日
最初に提出
2026年4月9日
QC基準を満たした最初の提出物
2026年5月13日
最初の投稿 (実際)
2026年5月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月20日
QC基準を満たした最後の更新が送信されました
2026年5月13日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025-183-02
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いいえ
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