Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly

Descriptive Information
Brief Title ^†	Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly
Official Title ^†
Brief Summary	OBJECTIVES: I. Determine whether release of endogenous growth hormone (GH)-releasing hormone is involved in GH responses to clonidine, pyridostigmine, levodopa, arginine, GH-releasing peptide, insulin-induced hypoglycemia, and exercise in patients with acromegaly. II. Determine whether endogenous GH-releasing hormone influences the maintenance of GH hypersecretion.
Detailed Description	PROTOCOL OUTLINE: Growth hormone-releasing hormone antagonist (GHRH-A) is administered to volunteers and followed with 1 of these challenges: insulin, clonidine, pyridostigmine, arginine, levodopa, growth hormone-releasing peptide, or exercise. Tests are repeated with normal saline as the control; the order of administration (control vs. pharmacologic stimulation) is randomly assigned. Patients receive GHRH-A (dose determined in volunteer study), thyrotropin-releasing hormone, and growth-releasing hormone. All stimulation tests follow an overnight fast.
Study Phase	N/A
Study Type ^†	Observational
Study Design ^†	Primary Purpose: Screening
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Acromegaly
Intervention ^†
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†
Estimated Enrollment ^†	148
Start Date ^†	May 1993
Completion Date
Primary Completion Date
Eligibility Criteria ^†	PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Active acromegaly with growth hormone (GH) hypersecretion confirmed within 1 month prior to entry, i.e.: Somatomedin C elevated GH not below 2 ng/mL on standard 100 g oral glucose tolerance test Postmenopausal and hypogonadal women eligible Volunteers aged 18 to 30 recruited for up to 3 stimulation tests Weight within 15% of ideal Physical exam normal No history of disease No requirement for medication No medical or mental contraindication to protocol participation, including heavy alcohol or tobacco use No pregnant women --Prior/Concurrent Therapy-- Not specified --Patient Characteristics-- Age: 18 to 65 Hematopoietic: No anemia Hepatic: No hepatic disease Renal: No renal disease Cardiovascular: No uncontrolled hypertension No heart disease Other: No requirement for replacement gonadal steroids, glucocorticoids, or thyroxine No mental illness No heavy alcohol use No tobacco use No drug abuse No medical contraindication to protocol therapy
Gender	Both
Ages	18 Years - 65 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts ^††	, , , ,
Location Countries ^†
Administrative Information
NCT ID ^†	NCT00004332
Organization ID	199/11890
Secondary IDs ^††	UMMC-1016
Responsible Party	,
Study Sponsor ^†	National Center for Research Resources (NCRR)
Collaborators ^††	University of Michigan
Investigators ^†	Study Chair: Ariel Barban, University of Michigan
Information Provided By	Office of Rare Diseases (ORD)
Verification Date	January 2000
First Received Date ^†	October 18, 1999
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.