The Contribution of Incretin Hormones to the Amelioration of Glucose Metabolism After Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Adrian Vella
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB)
研究概览
简要总结
The study is being undertaken to understand how a gastric bypass can affect a subject's diabetes even prior to their losing significant amounts of weight. The hypothesis of this study is that increased glucagon-like peptide-1 (GLP-1) secretion explains the amelioration in insulin secretion after Roux-en-Y Gastric Bypass (RYGB) surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 2 diabetes mellitus or impaired fasting glucose concentration of > 110 mg/dL
- •Subjects registered to receive a Roux-en-Y Gastric Bypass (RYGB).
排除标准
- •Subjects taking thiazolidinediones
- •Subjects with active systemic illness
- •Subjects with active microvascular or macrovascular complications of their diabetes
- •For female subject: positive pregnancy test at the time of enrollment in study
研究组 & 干预措施
Exendin 9,39
Subjects randomized to this arm will receive an infusion of exendin 9,39 of 300mmol/kg/min for 360 minutes.
干预措施: Exendin 9,39 (Drug)
Placebo
Subjects randomized to this arm will receive a saline infusion for 360 minutes.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Total Disposition Index from Study 1 (pre-RYGB) to Study 2 (post-RYGB)
时间窗: baseline, 4 weeks post-operative intervention
The total disposition index equals the product of insulin secretion and insulin sensitivity.
次要结局
未报告次要终点
研究者
Adrian Vella
Consultant, Endocrinology
Mayo Clinic