Clinical trial NCT00397319: Growth Hormone's Effect on the Cardiovascular System
Official title: The Role of Growth Hormone in Cardiovascular Health
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Growth Hormone Deficiency
Keywords: Growth Hormone
Cardiovascular System
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Pfizer
name: National Center for Research Resources (NCRR)
First posted: 2006-11-09
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Doug Vaughan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Devin JK, Blevins LS Jr, Verity DK, Chen Q, Bloodworth JR Jr, Covington J, Vaughan DE. Markedly impaired fibrinolytic balance contributes to cardiovascular risk in adults with growth hormone deficiency. J Clin Endocrinol Metab. 2007 Sep;92(9):3633-9. doi: 10.1210/jc.2007-0609. Epub 2007 Jun 19.