Growth Hormone's Effect on the Cardiovascular System
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency
Intervention: Growth Hormone (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
Doug Vaughan, MD, Principal Investigator, Affiliation: Vanderbilt University
Summary
To evaluate specific markers of cardiovascular risk before and after growth hormone
replacement therapy in a population of growth hormone deficient adults, as compared to an
age, gender, and BMI-matched healthy population.
Clinical Details
Official title: The Role of Growth Hormone in Cardiovascular Health
Study design: Longitudinal, Case Control, Prospective Study
Detailed description:
Growth hormone deficiency (GHD) is associated with increased cardiovascular morbidity and
mortality. The effects of such a deficiency include decreased exercise capacity and
tolerance, impaired cardiac function, a central fat redistribution, increased peripheral
arterial resistance, and an unfavorable lipid profile. These effects have been found to be
reversed with appropriate replacement therapy with recombinant human growth hormone. We plan
to utilize several experimental systems to further investigate the role of growth hormone
(GH) in maintaining cardiovascular health. In particular, we would like to further understand
the interaction of GH with Plasminogen-activator-inhibitor-1 (a major activator of the
fibrinolytic system) as well as the role of GH in the maintenance of vascular function.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult between the ages of 18 and 65
- Documented Growth Hormone Deficiency as defined by a peak Growth Hormone during a
GHRH-Arginine Stimulation test not exceeding 9. 5 ng/ml
Exclusion Criteria:
- Personal history of cardiovascular disease (previous myocardial infarction or known
coronary artery disease) or diagnosis of heart disease between study visits.
- Personal history of diabetes mellitus or development of diabetes between study
visits.
- Initiation of an anti-cholesterol medication or anti-hypertensive between baseline and
follow-up study visit.
- Initiation of regular tobacco use between baseline and follow-up study visit.
- Pregnancy or nursing
- Current daily use of any drug known to affect the fibrinolytic system: Aspirin,
Aggrenox, Plavix, Persantine, Ticlid, Pletal, Trental, Lovenox, Coumadin, Agrylin, and
Hydroxyurea.
Locations and Contacts
Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States
Additional Information
Starting date: August 2005
Ending date: December 2006
Last updated: July 2, 2007
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