Weight Loss-Independent Metabolic Effects of Roux-En-Y Gastric Bypass in Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Changes in hepatic insulin sensitivity
研究概览
简要总结
For this purpose, we will compare the effects of targeted 16-18% (with a range of 16-25%) weight loss induced by Roux-en-Y Gastric bypass (RYGB) surgery with the same weight loss induced by a low-calorie diet (LCD) on liver and skeletal muscle insulin sensitivity, beta-cell function, and 24-hour metabolic homeostasis in obese subjects with or without T2D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For RYGB group:
- •Scheduled for this bariatric surgery
- •Body Mass Index (BMI) 34-55 kg/m²
- •Type 2 Diabetes
- •Signed informed consent
- •For Low-Calorie Diet group:
- •BMI 34-55 kg/m²
- •Type 2 Diabetes and Non-Diabetics
- •Signed informed consent
排除标准
- •For both RYGB & Low-Calorie Diet groups
- •Regular use of tobacco products
- •Previous intestinal resection
- •Pregnant or breastfeeding
- •Evidence of significant organ system dysfunction or disease other than T2D
- •Use of any medication that might, in the opinion of the investigator, affect metabolic function
- •Exercise ≥90 minutes per week
研究组 & 干预措施
Roux-en-Y gastric bypass (RYGB)
Subjects in this group are scheduled to undergo roux-en-Y gastric bypass surgery to obtain approximately 16-18% (with a range of 16-25%) weight loss.
干预措施: Roux-en-Y gastric bypass surgery (Procedure)
Low-calorie diet
Subjects in this group will participate in a low-calorie diet intervention to obtain approximately 16-18% (with a range of 16-25%) weight loss.
干预措施: Low-calorie diet (Behavioral)
结局指标
主要结局
Changes in hepatic insulin sensitivity
时间窗: 6 months (before and after targeted weight loss)
The outcome will be assessed by hyperinsulinemic-euglycemic-pancreatic-clamp procedure before and after weight loss.
次要结局
- Changes in body fat mass(6 months (before and after targeted weight loss))
- Changes in skeletal muscle and adipose tissue insulin sensitivity(6 months (before and after targeted weight loss))
- Changes in glucose kinetics (glucose concentration and rate of appearance into the systemic circulation) in response to mixed-meal ingestion(6 months (before and after targeted weight loss))
- Changes in 24-hour plasma insulin profile(6 months (before and after targeted weight loss))
- Changes in 24-hour plasma glucose profile(6 months (before and after targeted weight loss))
- Changes in 24-hour plasma free fatty acid profile(6 months (before and after targeted weight loss))
- Changes in fat free mass(6 months (before and after targeted weight loss))
- Changes in Beta-cell function(6 months (before and after targeted weight loss))
- Changes in intrahepatic triglyceride content(6 months (before and after targeted weight loss))
- Changes in intra-abdominal adipose tissue volume(6 months (before and after targeted weight loss))