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Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier:
NCT00447512
First received: March 13, 2007
Last updated: October 29, 2007
Last verified: October 2007

March 13, 2007
October 29, 2007
March 2004
Not Provided
sleep, conventionally and quantitatively analyzed [ Time Frame: study duration ]
sleep, conventionally and quantitatively analyzed
Complete list of historical versions of study NCT00447512 on ClinicalTrials.gov Archive Site
hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis [ Time Frame: study duration ]
hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis
Not Provided
Not Provided
 
Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Healthy
  • Major Depression
Drug: ghrelin
acylated ghrelin
Not Provided
Kluge M, Schüssler P, Schmidt D, Uhr M, Steiger A. Ghrelin suppresses secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) in women. J Clin Endocrinol Metab. 2012 Mar;97(3):E448-51. doi: 10.1210/jc.2011-2607. Epub 2012 Jan 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
October 2007
Not Provided

Inclusion Criteria:

  • Healthy females and males
  • Male and female patients with major depression

Exclusion Criteria:

  • 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
  • Smoking
  • Any medication during the week prior to study entry
  • Any current disease other than major depression
Both
20 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00447512
L2/2003
No
Not Provided
Max-Planck-Institute of Psychiatry
German Research Foundation
Principal Investigator: Professor Axel Steiger, MD Max-Planck-Institute of Psychiatry
Max-Planck-Institute of Psychiatry
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP