NCT05628584已完成不适用
The Impact of High or Low FODMAP Diets on Postprandial Glucose Response and Gut Microbiota in Individuals with Prediabetes Treated with Metformin: a Randomized Crossover Controlled-Feeding Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Elaine Chow
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Differences in postprandial glycemia
研究概览
简要总结
This is a prospective, double blinded, randomised cross over feeding trial examine high or low FODMAP diet in combination with metformin on postprandial glucose responses and gastrointestinal tolerability and gut microbiota profiles.
The trial will compare high or low FODMAP diet, each of 10 days duration in combination with 5 days metformin, separated by a washout period of at least 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years
- •Body mass index 18 to 40 kg/m 2
- •Prediabetes defined as impaired fasting PG 5.6-6.9 mmol/l and/or impaired glucose tolerance with 2-hour PG 7.8-11.1 mmol/l on 75g oral glucose tolerance test (OGTT) and/or HbA1c 5.7-6.4% at screening
排除标准
- •Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy
- •Known current diabetes
- •Current or previous use of glucose-lowering or weight loss drugs in 3 months prior to screening
- •Concurrent participation in other weight loss or lifestyle intervention programmes
- •Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
- •Recent intake of prebiotic/probiotic or antibiotic, immunosuppressants (within 8 weeks of randomisation)
- •Extensive skin changes/diseases that preclude wearing the FGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
- •Known uncontrolled thyrotoxicosis
- •Known vitamin B deficiency
- •Known irritable bowel syndrome or gastrointestinal disorders
- •Estimated glomerular filtration rate (eGFR) <45 ml/min/1.73m2 at screening
- •Current use of steroids
- •Have a known allergy to medical-grade adhesives
- •Known current or recent alcohol or drug abuse
- •Hypersensitivity to metformin
- •Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma within 3 months of randomisation
- •Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
- •An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
- •Participants who are on a vegetarian or vegan diet as their habitual diet at screening.
- •Participants with clinically significant food allergy to components of the study diet
结局指标
主要结局
Differences in postprandial glycemia
时间窗: 10 days
incremental area under curve on continuous glucose monitoring post meal
次要结局
- Body weight(10 days)
- Glucose response to 75g oral glucose tolerance test(10 days)
- Insulin response to 75g oral glucose tolerance test(10 days)
- Change in alpha diversity of gut microbiota(10 days)
- Change in beta diversity of gut microbiota(10 days)
- Gastrointestinal symptoms(10 days)
研究者
Elaine Chow
Clinical Assistant Professor
Chinese University of Hong Kong
研究点 (1)
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