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

This study has been completed.
University of Michigan
Information provided by:
Office of Rare Diseases (ORD) Identifier:
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: January 2000

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.


Study Type: Observational
Study Design: Primary Purpose: Screening

Resource links provided by NLM:

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 148
Study Start Date: May 1993
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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


--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

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Please refer to this study by its identifier: NCT00004332

Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Michigan
Study Chair: Ariel Barban University of Michigan
  More Information Identifier: NCT00004332     History of Changes
Other Study ID Numbers: 199/11890
Study First Received: October 18, 1999
Last Updated: June 23, 2005

Keywords provided by Office of Rare Diseases (ORD):
endocrine disorders
rare disease

Additional relevant MeSH terms:
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormone Antagonists
Growth Hormone-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormones processed this record on June 23, 2017