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

NCT00001180 | Completed

• 2 other identifiers: 82004582-CH-0045
• Study Type: observational
• Target: 2,250
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Gland Hyperfunction; Adrenal Gland Hypofunction; Cushing's Syndrome; Healthy

Keywords

Corticotropin Releasing Hormone; Cushing Syndrome; Psychiatric Hypercortisolism; Adrenal Insufficiency; Normal Volunteer

Interventions

Ovine Corticotropin-Releasing Hormone (oCRH) DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

National Institute of Child Health and Human Development (NICHD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.7326/0003-4819-102-3-344.

  PMID: 2982307 BACKGROUND

• 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. doi: 10.1210/jcem-58-1-192.

  PMID: 6605972 BACKGROUND

• Schurmeyer 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. doi: 10.1210/jcem-59-6-1103.

  PMID: 6092407 BACKGROUND

MeSH Terms

Conditions

Adrenocortical Hyperfunction; Adrenal Insufficiency; Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: March 1, 1982
• Study Completion: June 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-06

Locations

US (1)