Brief Title
Growth Hormone's Effect on the Cardiovascular System
Official Title
The Role of Growth Hormone in Cardiovascular Health
Brief 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.
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.
Study Type
Observational
Condition
Growth Hormone Deficiency
Intervention
Growth Hormone
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
26
Start Date
August 2005
Completion Date
December 2006
Eligibility 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.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Doug Vaughan, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00397319
Organization ID
050045
Secondary IDs
1422
Study Sponsor
Vanderbilt University
Collaborators
Pfizer
Study Sponsor
Doug Vaughan, MD, Principal Investigator, Vanderbilt University Medical Center
Verification Date
July 2007