Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
|ClinicalTrials.gov Identifier: NCT00447512|
Recruitment Status : Completed
First Posted : March 14, 2007
Last Update Posted : October 31, 2007
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).
|Condition or disease||Intervention/treatment||Phase|
|Healthy Major Depression||Drug: ghrelin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones|
|Study Start Date :||March 2004|
|Actual Study Completion Date :||October 2007|
- sleep, conventionally and quantitatively analyzed [ Time Frame: study duration ]
- hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis [ Time Frame: study duration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447512
|Max Planck Institute of Psychiatry|
|Munich, Germany, 80804|
|Principal Investigator:||Professor Axel Steiger, MD||Max-Planck-Institute of Psychiatry|