Protocol Number: 82-CH-0045

Title:

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

Number:

82-CH-0045

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.

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility 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.

Special Instructions: Currently Not Provided

Keywords:

Corticotropin Releasing Hormone

Cushing Syndrome

Psychiatric Hypercortisolism

Adrenal Insufficiency

Recruitment Keywords:

Normal Volunteer

Conditions:

Adrenal Gland Hyperfunction

Adrenal Gland Hypofunction

Cushing's Syndrome

Healthy

Investigational Drug(s):

Ovine Corticotropin-Releasing Hormone (oCRH)

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

The clinical applications of corticotropin-releasing factor; a conference of the combined clinical staff of the National Institutes of Health

Corticotropin releasing factor: pharmacokinetics in man

Human corticotropin releasing factor in man; pharmacokinetic properties and does-response of plasma, ACTH and cortisol secretion

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Bethesda, Maryland 20892. Last update: 10/20/2004