A Dose-response Study of the Effects of Exendin-9,39 on Gastrointestinal Symptoms and Food Intake.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Calories consumed during buffet meal test
研究概览
简要总结
Exendin-(9,39) has been shown to have effects on beta-cell function, and after gastric bypass, to accelerate gastrointestinal transit. - infused at rates of 300pmol/kg/min. Given that gastrointestinal transit is typically delayed by Glucagon-Like Peptide-1 (GLP-1) and also that this hormone causes decreased food intake through increased satiation, it is reasonable to expect an effect of Exendin-9,39 on appetite. This may help explain the effects of gastric bypass on food intake. To examine the effect of Exendin on food intake we propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion. We will examine the presence of gastrointestinal symptoms as well as food intake in the immediate aftermath of a test meal and the subsequent hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have undergone Roux en-Y Gastric Bypass at least 6 months prior to enrollment in the study.
- •Subjects without active systemic illness.
排除标准
- •Subjects <20 years of age will not be studied to minimize the possibility of type 1 diabetes.
- •Subjects >70 years of age will not be studied to minimize the potential confounding effects of age on glucose tolerance.
研究组 & 干预措施
Saline
a saline infusion will be started and maintained till the end of the study at 1300 (300 minutes).
干预措施: Saline (Other)
Exendin-9,39 @ 300
Exendin-9,39 @ 300pmol/kg/min
干预措施: Exendin-9,39 (Drug)
Exendin-9,39 @ 750
Exendin-9,39 @ 750pmol/kg/min
干预措施: Exendin-9,39 (Drug)
结局指标
主要结局
Calories consumed during buffet meal test
时间窗: approximately 300 minutes after initiation
The calories consumed during buffet meal test at the end of each study test will help determine the effect of GLP-1 receptor blockade with Exendin-9,39 on food intake.
次要结局
未报告次要终点
研究者
Adrian Vella
Consultant, Endocrinology
Mayo Clinic