Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism

NCT00666068 | Completed

• 1 other identifier: L2/2003A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine responses when hormones are injected. This is at least true for those with a complete insufficiency of the anterior pituitary. For example, administration of corticotropin releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore, "pure" hormone effects can be investigated. It is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was therefore to study the effect of CRH on patients with hypopituitarism. To date, there is no information on sleep of patients with hypopituitarism. Secondary objective is therefore to compare sleep of patients with hypopituitarism with sleep of age-matched healthy controls.

Conditions

Hypopituitarism

Keywords

Patients with hypopituitarism

Outcome Measures

Primary Outcomes (1)

• Sleep-EEG variables, conventionally and quantitatively analyzed

  within the first month

Study Arms (2)

1

EXPERIMENTAL

Patients with hypopituitarism Cross over design: see interventions 1-2

Other: corticotropin releasing hormone (CRH); Other: Placebo

2

PLACEBO COMPARATOR

Parallel design: Healthy controls to be compared with placebo condition in patients with hypopituitarism

Other: Placebo

Interventions

corticotropin releasing hormone (CRH) OTHER

50 µg injected at 2200, 2300, 0000, and 0100

1

Placebo OTHER

injected at 2200, 2300, 0000, and 0100

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• Complete insufficiency of the anterior pituitary
• Stable hormone substitution for at least 3 months

You may not qualify if:

• Hormone excess in the past
• Sleep disorder, e.g. sleep apnea syndrome
• Healthy controls
• Age 18-75 years
• Any medication during 6 week prior to study entry
• Shift work

Sponsors & Collaborators

• Max-Planck-Institute of Psychiatry: lead

Study Sites (1)

Max Planck Institute of Psychiatry

Munich, 80804, Germany

Location

MeSH Terms

Conditions

Hypopituitarism

Interventions

Corticotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

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: April 22, 2008
• First Posted: April 24, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 12, 2011

Record last verified: 2011-05

Locations

DE (1)