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

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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Brief Title

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

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 Type

Observational

Condition

Acromegaly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

148

Start Date

May 1993

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

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Ariel Barban, ,

Administrative Informations

NCT ID

NCT00004332

Organization ID

199/11890

Secondary IDs

UMMC-1016

Study Sponsor

National Center for Research Resources (NCRR)

Collaborators

 University of Michigan

Study Sponsor

Ariel Barban, Study Chair, University of Michigan

Verification Date

January 2000