Fecal Microbiota Transplantation (FMT) Combined With Calorie-Restricted Diet and Semaglutide in Patients With Obesity and Type 2 Diabetes
13 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
Условия
Подробное описание
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).
Тип исследования
Интервенционный
Регистрация (Оцененный)
20
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Yunfeng Shen, Ph.D
- Номер телефона: 0755-83982222
- Электронная почта: shenyf26@mail.sysu.edu.cn
Места учебы
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Guangdong
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Shenzhen, Guangdong, Китай, 518033
- Eighth Affiliated Hospital, Sun Yat-sen University
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Контакт:
- Yunfeng Shen, Ph.D
- Номер телефона: 0755-83982222
- Электронная почта: shenyf26@mail.sysu.edu.cn
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-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
Другие имена:
Semaglutide 1.0 mg subcutaneous injection once weekly
Другие имена:
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.
Другие имена:
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Активный компаратор: 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
Другие имена:
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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Percent change in body weight
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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The proportion of participants achieving ≥5% body weight reduction
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
30 апреля 2026 г.
Первичное завершение (Оцененный)
30 января 2027 г.
Завершение исследования (Оцененный)
30 декабря 2029 г.
Даты регистрации исследования
Первый отправленный
9 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
13 мая 2026 г.
Первый опубликованный (Действительный)
20 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
20 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
13 мая 2026 г.
Последняя проверка
1 апреля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания эндокринной системы
- Расстройства питания
- Метаболические заболевания
- Переедание
- Масса тела
- Нарушения метаболизма глюкозы
- Сахарный диабет
- Избыточный вес
- Патологические состояния, признаки и симптомы
- Пищевые и метаболические заболевания
- Признаки и симптомы
- Ожирение
- Сахарный диабет, тип 2
- Терапия
- Диета, еда и питание
- Физиологические явления
- Пищевые физиологические явления
- Диетическая терапия
- Питательная терапия
- Диета
- Биологическая терапия
- Потребление энергии
- полуглутид
- Фекальная трансплантация микробиоты
- Ограничение калорий
Другие идентификационные номера исследования
- 2025-183-02
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .