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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Healthy Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Interventions

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ghrelin

acylated ghrelin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Professor Axel Steiger, MD

Role: PRINCIPAL_INVESTIGATOR

Max-Planck-Institute of Psychiatry

Locations

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Max Planck Institute of Psychiatry

Munich, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED

PMID: 22259063 (View on PubMed)

Other Identifiers

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L2/2003

Identifier Type: -

Identifier Source: org_study_id