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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447512
• Other study ID #: L2/2003
• Status: Completed
• Phase: N/A
• First received: March 13, 2007
• Last updated: October 29, 2007
• Start date: March 2004
• Est. completion date: October 2007

Study information

• Verified date: October 2007
• Source: Max-Planck-Institute of Psychiatry
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Healthy
• Major Depression

Intervention

Drug:
• ghrelin
acylated ghrelin

Locations

Country	Name	City	State
Germany	Max Planck Institute of Psychiatry	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Max-Planck-Institute of Psychiatry	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sleep, conventionally and quantitatively analyzed		study duration
Secondary	hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis		study duration