Growth Hormone’s Effect on the Cardiovascular System

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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