NCT03842475招募中不适用
Who Will Benefit From Bariatric Surgery for Diabetes? Using Fat Distribution Measurement, Gut Hormone Profiles and Genetic Data to Predict Diabetes Remission
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Diabetes remission (complete)
研究概览
简要总结
A study investigating the influence of fat distribution, genetic susceptibility markers for type 2 diabetes (T2DM) and fat distribution, epigenetic and transcriptomic changes and gut hormone responses to a mixed meal on diabetes remission following bariatric surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females planning to undergo RYGB
- •18-80 years
- •Type 2 diabetes mellitus or prediabetes
- •Stable weight for at least 3 months
- •Obese (BMI ≥30kg/m2)
- •Eligible for surgery on the National Health Service (NHS) under The National Institute for Health and Care Excellence (NICE) 2014 criteria
排除标准
- •Current pregnancy
- •Inability to give informed consent
- •Type 1 diabetes
- •Low fasting C-peptide
- •Secondary diabetes or absence of β-cell function
- •Unable to undergo DEXA, cirrhosis, ascites, or other condition that may modify body fat composition e.g. underlying malignancy
- •Current smoker
- •Participation in another (interventional) trial within the last 3 months
- •Unable to understand English
- •Healthy volunteers
- •Inclusion criteria:
- •Aged 18-80 years
- •Male or female
- •Body mass index 19 - 25 kg/m2
- •Stable weight for at least three months
- •Exclusion criteria:
- •Abnormal glucose tolerance and fasting glucose
- •History of any medical, or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study
- •Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study
- •Pregnancy or breastfeeding
- •Unable to maintain adequate contraception for the duration of the study
- •Donated blood during the preceding 3 months or intention to do so before the end of the study
- •Current smoker
- •Participation in another trial within the last 3 months
- •Unable to understand English
结局指标
主要结局
Diabetes remission (complete)
时间窗: 1 year
Diabetes remission (partial or complete)
时间窗: 1 year
次要结局
- Body mass index (kg/m2)(1 year)
- Weight loss(1 year)
- Waist circumference, waist/hip ratio (cm)(1 year)
- Change in visceral adipose tissue(1 year)
- Change in ectopic fat(1 year)
研究者
研究点 (1)
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