Effect of Exenatide on Cortisol Secretion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cortisol peak
研究概览
简要总结
The primary aim of the study is to describe the effect of single dose of 10 micrograms (μg) exenatide given subcutaneously (s/c) on cortisol secretion. Secondary outcomes involve ACTH and glucose levels.
详细描述
Exenatide is a short-acting Glucagon-Like Peptide receptor 1 (GLP-1 R) agonist.
The clinical trial is conducted in10 healthy volunteers. Each subject receives one dose of subcutaneous exenatide (10 μg). After that, hormonal and physiological changes are measured during two hours. The blood samples are taken in 30-minute intervals.
The primary endpoint is peak value of cortisol achieved during the 2 hours after drug administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years
- •Body weight >65 kg
排除标准
- •Presence of chronic illness
- •daily use of any medicines
- •pregnancy, lactation
- •use of oral contraceptives during previous 2 months
研究组 & 干预措施
Exenatide
Single injection of 10 μg Exenatide subcutaneously.
干预措施: Exenatide Injection (Drug)
结局指标
主要结局
Cortisol peak
时间窗: every 30 minutes during 2 hours after injection
Maximum concentration achieved after exenatide dose (any timepoint after injection)
次要结局
- Adrenocorticotropin (ACTH) peak(every 30 minutes during 2 hours after injection)
- Glucose(Glucose measured every 30 minutes during 2 hours after injection)
- Growth hormone(every 30 minutes during 2 hours after injection)
研究者
Vallo Volke
Professor
University of Tartu