Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00001180

Recruitment Status : Completed

First Posted : November 4, 1999

Last Update Posted : March 4, 2008

Sponsor:

Information provided by:

National Institutes of Health Clinical Center (CC)

Study Description

Brief Summary:

Corticotropin Releasing Hormone (CRH) is a hypothalamic hormone made up of 41 amino acids. Amino acids are proteins that when combined make up different substances, like hormones. The order of amino acids in CRH, has been determined, meaning that the hormone can now be synthetically reproduced in a laboratory setting.

When CRH is released from the hypothalamus it stimulates the pituitary gland to secrete another hormone, ACTH. ACTH then causes the adrenal glands to make a third hormone, cortisol. This process is known as the hypothalamic-pituitary-adrenal axis. Problems can occur in any of the steps of this process and result in a variety of diseases (Cushing's Syndrome and adrenal insufficiency).

Researchers hope that CRH created in a laboratory setting, ovine CRH (oCRH) can be used to help diagnose and treat conditions of the HPA axis. This study will test the relationship for single doses of oCRH in normal volunteers and patients with disorders of the HPA axis. The oCRH will be injected into the patients vein as a single injection or slowly through an IV line over 24 hours. The participants will have blood tests taken to measure hormone levels before, during, and after receiving the oCRH.

Condition or disease	Intervention/treatment
Adrenal Gland Hyperfunction Adrenal Gland Hypofunction Cushing's Syndrome Healthy	Drug: Ovine Corticotropin-Releasing Hormone (oCRH)

Detailed Description:

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.

Study Design


Study Type :	Observational
Enrollment :	2250 participants
Official Title:	Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency
Study Start Date :	March 1982
Study Completion Date :	June 2005

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Cushing disease Autoimmune Addison disease Familial glucocorticoid deficiency

MedlinePlus related topics: Hormones

Drug Information available for: Corticotropin

Genetic and Rare Diseases Information Center resources: Hypoadrenalism Cushing's Syndrome Hyperadrenalism Addison's Disease

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001180

Locations


United States, Maryland
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

Publications:

Chrousos GP, Schuermeyer TH, Doppman J, Oldfield EH, Schulte HM, Gold PW, Loriaux DL. NIH conference. Clinical applications of corticotropin-releasing factor. Ann Intern Med. 1985 Mar;102(3):344-58. Review.

Schulte HM, Chrousos GP, Booth JD, Oldfield EH, Gold PW, Cutler GB Jr, Loriaux DL. Corticotropin-releasing factor: pharmacokinetics in man. J Clin Endocrinol Metab. 1984 Jan;58(1):192-6.

Schürmeyer TH, Avgerinos PC, Gold PW, Gallucci WT, Tomai TP, Cutler GB Jr, Loriaux DL, Chrousos GP. Human corticotropin-releasing factor in man: pharmacokinetic properties and dose-response of plasma adrenocorticotropin and cortisol secretion. J Clin Endocrinol Metab. 1984 Dec;59(6):1103-8.


ClinicalTrials.gov Identifier:	NCT00001180 History of Changes
Other Study ID Numbers:	820045 82-CH-0045
First Posted:	November 4, 1999 Key Record Dates
Last Update Posted:	March 4, 2008
Last Verified:	June 2005

Keywords provided by National Institutes of Health Clinical Center (CC):


Corticotropin Releasing Hormone Cushing Syndrome Psychiatric Hypercortisolism Adrenal Insufficiency Normal Volunteer

Additional relevant MeSH terms:


Cushing Syndrome Adrenal Insufficiency Addison Disease Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Hormones Adrenocorticotropic Hormone Corticotropin-Releasing Hormone Epinephrine Racepinephrine Epinephryl borate Hormones, Hormone Substitutes, and Hormone Antagonists	Physiological Effects of Drugs Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents

To Top