AcromegalyNCT00004332
Study of the Effect of Growth Hormone-Releasing Hormone Antagonist on Growth Hormone Release in Acromegaly
An observational study of Acromegaly, run by National Center for Research Resources (NCRR).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acromegaly
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- May 1993to not given
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
About this study
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.
Read the 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.
- Conditions
- Acromegaly
- Keywords
- acromegaly, endocrine disorders, rare disease
- Medical subject headings
- Acromegaly, Endocrine System Diseases, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startMay 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 148 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Michigan
- Investigators
- Ariel Barban, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004332
- Sponsor's protocol ID
- 199/11890
- Other IDs
- UMMC-1016
- Status last verified
- Jan 2000
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No