Trial record 6 of 14 for:    nichd Cushing's Syndrome

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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001180
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: June 2005
  Purpose

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

Study Type: Observational
Official Title: Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone (CRH) in Normal Volunteers and in Patients With Adrenal Insufficiency

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 2250
Study Start Date: March 1982
Estimated Study Completion Date: June 2005
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.

  Eligibility

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001180

Locations
United States, Maryland
National Institute of Child Health and Human Development (NICHD)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001180     History of Changes
Other Study ID Numbers: 820045, 82-CH-0045
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

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
Adrenocortical Hyperfunction
Adrenal Insufficiency
Addison Disease
Adrenal Gland Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Adrenocorticotropic Hormone
Corticotropin-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014