The Role of Glucagon Like Peptide-1 in Glucose Metabolism and Weight Loss Following Gastric Bypass Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The investigator measure glucose, islet and GI hormonal levels in response to meal ingestion as a composite measure and the percentage of contribution of GLP-1 contribution to postprandial insulin levels will also be calculated
研究概览
简要总结
The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.
The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.
- To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.
- To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.
- To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.
详细描述
The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.
The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.
- To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.
- To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.
- To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-65
- •healthy control without diabetes or active organ disease
- •Individuals with bariatric surgery
- •recurrent hypoglycemia post gastric bypass
排除标准
- •pregnancy
- •significant anemia
- •diabetes currently unless pre-op for bariatric surgery procedure
- •GI obstruction
研究组 & 干预措施
hyperglycemic clamp-Meal tolerance test
these studies are to evaluate the effect of exendin-9 on insulin secretion before and after meal ingestion in patients after bariatric surgeries compared to non-surgical controls
干预措施: exendin-(9-39) (Drug)
Labeled meal tolerance test
The effect of GLP-1 receptor blockade on glucose tolerance and glucose kinetics are evaluated in the group patients with bariatric surgery vs. nonsurgical using exendin-9-39 infusion during one of the the 2-day dual tracer studies of meal tolerance test
干预措施: exendin -(9-39) (Drug)
结局指标
主要结局
The investigator measure glucose, islet and GI hormonal levels in response to meal ingestion as a composite measure and the percentage of contribution of GLP-1 contribution to postprandial insulin levels will also be calculated
时间窗: up to 1 year (10 sessions)
次要结局
未报告次要终点