The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Insulin Secretion
研究概览
简要总结
This study is being conducted to evaluate changes in sugar, metabolism, heart function and changes in body composition as patients lose weight following bariatric surgery. The investigators will compare improvements of the above changes as a function of the four different types of bariatric surgery. The investigators believe the most beneficial and safest procedure will be the Roux-en-Y.
详细描述
The study will also examine the response of the pancreas (the insulin-producing organ) to a sugar load, as well as to a hormone called Glucagon Like Peptide 1 (GLP-1), which is released from your gut to maximally stimulate your pancreas. The release of this hormone increases when you eat food and it causes the pancreas to release more insulin than does sugar alone. Volunteers will have 22 visits over a two year period. Only people having Roux-en-Y gastric bypass surgery, gastric sleeve surgery, duodenal switch gastric surgery or lap-band/gastric banding surgery may join. Seventy volunteers will be recruited to take part in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female volunteers 21-65 years.
- •Preoperative hematocrit level of at least 34% for women and 38% for men.
- •Postoperative hematocrit level of at least 34% for women and 36% for men.
排除标准
- •Volunteers whose hematocrit level does not meet the above criteria.
- •Pregnant and or lactating females.
研究组 & 干预措施
GLP-1
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
干预措施: GLP-1 (Drug)
结局指标
主要结局
Insulin Secretion
时间窗: 2 years
次要结局
未报告次要终点