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

NCT00447512 | Completed

• 1 other identifier: L2/2003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy; Major Depression

Outcome Measures

Primary Outcomes (1)

• sleep, conventionally and quantitatively analyzed

  study duration

Secondary Outcomes (1)

• hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis

  study duration

Interventions

ghrelin DRUG

acylated ghrelin

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead
• German Research Foundation: collaborator

Study Sites (1)

Max Planck Institute of Psychiatry

Munich, 80804, Germany

Location

Related Publications (1)

• 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.

  PMID: 22259063 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ghrelin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Professor Axel Steiger, MD

  Max-Planck-Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 14, 2007
• Study Start: March 1, 2004
• Study Completion: October 1, 2007
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

DE (1)