Pharmacokinetics of Ghrelin in Normal Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Human ghrelin half life in healthy subjects
研究概览
简要总结
The main purpose of this study is to determine the half life of the hormone "ghrelin" in the human body. Other purposes are to investigate the effect of ghrelin on appetite and cardiovascular function.
详细描述
Ghrelin is a recently described acylated peptide hormone produced by the enteroendocrine cells of the mucosal epithelial layer in the ventricle. Ghrelin is the endogenous ligand for the growth hormone (GH) secretagogue receptor (GHS-R).
Ghrelin stimulates pituitary GH release by binding to the GHS-R at both hypothalamic and pituitary levels.
Several studies show that bolus injections of ghrelin have positive effects on cardiac function in healthy humans as well as in humans with cardiac disease. We investigate the changes in cardiac function during ghrelin infusion in healthy subjects.
The pharmacokinetics of ghrelin is described in few studies only, and we aim to elucidate this aspect further.
Comparisons: In a double blind, placebo controlled, cross over study we investigate the effect of 180 minutes ghrelin infusion on 1. cardiac function (tissue Doppler, stroke-velocity index), 2. vascular tone (a. brachialis dilatation), 3. ghrelin-half-life (acylated and des-acylated) and other pharmacokinetic parameters and 4. effect on appetite.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •BMI < 25 kg/m2
- •Non-smoker
- •Age < 40 yrs
排除标准
- •Any known disease
- •Any medication (except OTCs)
- •Former malignant disease
- •Alcoholism
- •Blood donation (with in 6 months)
- •Allergy to test medication
结局指标
主要结局
Human ghrelin half life in healthy subjects
次要结局
- Cardiovascular indices (stroke-velocity index, TEI-index)