Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acromegaly
Phase: N/A
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Ariel Barban, Study Chair, Affiliation: University of Michigan
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.
Clinical Details
Study design: Screening
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: May 1993
Last updated: June 23, 2005
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