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NCT00004332 Clinical Trial

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

Acromegaly Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004332
Other study ID # 199/11890
Secondary ID UMMC-1016
Status Completed
Phase N/A
First received October 18, 1999
Last updated June 23, 2005
Start date May 1993

Study information
Verified date January 2000
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 148
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) University of Michigan
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