Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
Primary Purpose
Healthy, Major Depression
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ghrelin
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
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
Sites / Locations
- Max Planck Institute of Psychiatry
Outcomes
Primary Outcome Measures
sleep, conventionally and quantitatively analyzed
Secondary Outcome Measures
hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis
Full Information
NCT ID
NCT00447512
First Posted
March 13, 2007
Last Updated
October 29, 2007
Sponsor
Max-Planck-Institute of Psychiatry
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00447512
Brief Title
Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
Official Title
Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Max-Planck-Institute of Psychiatry
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Major Depression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ghrelin
Intervention Description
acylated ghrelin
Primary Outcome Measure Information:
Title
sleep, conventionally and quantitatively analyzed
Time Frame
study duration
Secondary Outcome Measure Information:
Title
hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis
Time Frame
study duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Axel Steiger, MD
Organizational Affiliation
Max-Planck-Institute of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Max Planck Institute of Psychiatry
City
Munich
ZIP/Postal Code
80804
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22259063
Citation
Kluge M, Schussler 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.
Results Reference
derived
Learn more about this trial
Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
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