Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- sleep, conventionally and quantitatively analyzed
研究概览
简要总结
Ghrelin, an acylated peptide consisting of 28 amino acids, is the endogenous ligand of the growth hormone secretagogue receptor (GHS-R). It is synthesized predominantly in the stomach but has been also identified in a variety of other organs. Alike, a wide range of central and peripheral endocrine and non-endocrine actions has been described, e. g. being a releasing factor of growth hormone, prolactin and ACTH, a modulator of cell proliferation and apoptosis, a regulator of sleep-wake regulation, and a orexigenic hormone. Aims of this study are:
A) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in healthy subjects of both genders (age groups: 20-30, 35-45, 60-70 years).
B) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the HPA axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in patients with major depression (age range: 20-65 years).
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
- Single (Participant)
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
- 是
入选标准
- •Healthy females and males
- •Male and female patients with major depression
排除标准
- •Life time or family history of psychiatric or neurological disorders
- •Sleep disturbances
- •Shift work
- •Any current disease
- •Any medication
- •Long distance flight within 3 months prior to study entry
- •Any medication during the week prior to study entry
- •Any current disease other than major depression
结局指标
主要结局
sleep, conventionally and quantitatively analyzed
时间窗: study duration
次要结局
- hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis(study duration)