Growth Hormone's Effect on the Cardiovascular System

Growth Hormone Deficiency Clinical Trial

Official title:

The Role of Growth Hormone in Cardiovascular Health

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00397319
• Other study ID #: 050045
• Secondary ID: 1422
• Status: Terminated
• Phase: N/A
• First received: November 8, 2006
• Last updated: July 2, 2007
• Start date: August 2005
• Est. completion date: December 2006

Study information

• Verified date: July 2007
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency

Intervention

Drug:
• Growth Hormone

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University	National Center for Research Resources (NCRR), Pfizer

Country where clinical trial is conducted

United States,