Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001180
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone CRH in Normal Volunteers and in Patients With Adrenal Insufficiency
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Dose Response Relationship for Single Doses of Corticotropin Releasing Hormone CRH in Normal Volunteers and in Patients With Adrenal Insufficiency
Status:
COMPLETED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Cushings 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
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 Cushings 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
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 pgkg given as a bolus or up to 1 ugkgb 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 82-CH-0045 | None | None | None |