Completed

Dose-Response Relationship of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and Adrenal Insufficiency Patients

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Study Aim

This study aims to observe how different doses of Corticotropin Releasing Hormone (CRH) affect normal volunteers and patients with adrenal insufficiency.

What is being collected

Drug Data

Drug
Who is being recruted

Adrenal Gland Diseases+2

+ Endocrine System Diseases

+ Adrenocortical Hyperfunction

See all eligibility criteria
How is the trial designed

Observational
Study Start: March 1982
See protocol details

Summary

Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1982

Actual date on which the first participant was enrolled.

Corticotropin-releasing hormone (CRH) is a 41 amino acid hypothalamic peptide whose chemical structure has recently been determined after more than two decades of intensive research. This peptide stimulates secretion of ACTH by the corticotroph cells of the pituitary gland. As with the previously discovered hypothalamic hormones, CRH has important diagnostic and therapeutic applications. This study seeks to explore these clinical applications by determining the dose-response relationship for single doses of ovine CRH (oCRH) in normal volunteers and in patients with disorders of the hypothalamic-pituitary-adrenal axis. CRH is administered intravenously at doses up to 10 pg/kg, given as a bolus or up to 1 ug/kg/b as a continuous infusion lasting up to 24 hours. Plasma levels of ACTH, cortisol and CRH are measured before, during and after CRH administration.

NCT00001180
Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Adrenal Gland DiseasesEndocrine System DiseasesAdrenocortical HyperfunctionAdrenal InsufficiencyCushing Syndrome

Criteria

INCLUSION CRITERIA: The normal volunteers are obtained through the NIH volunteer program or are NIH employees. Normal volunteers are in excellent health and are receiving no chronic medications. We now routinely test patients with hypocortisolism or hypercortisolism in our clinic and ward.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Child Health and Human Development (NICHD)

Bethesda, United StatesOpen National Institute of Child Health and Human Development (NICHD) in Google Maps
CompletedOne Study Center