Growth Hormone's Effect on the Cardiovascular System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00397319
Recruitment Status : Terminated (Inadequate retention of GHD adults to maintain power to study the effect of GH on fibrinolysis. A comparison between GHD adults and controls was completed.)
First Posted : November 9, 2006
Last Update Posted : July 3, 2007
National Center for Research Resources (NCRR)
Information provided by:
Vanderbilt University

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.

Condition or disease Intervention/treatment
Growth Hormone Deficiency Drug: Growth Hormone

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
Enrollment : 26 participants
Observational Model: Case Control
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: The Role of Growth Hormone in Cardiovascular Health
Study Start Date : August 2005
Actual Study Completion Date : December 2006

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00397319

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Center for Research Resources (NCRR)
Principal Investigator: Doug Vaughan, MD Vanderbilt University Medical Center

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00397319     History of Changes
Other Study ID Numbers: 050045
First Posted: November 9, 2006    Key Record Dates
Last Update Posted: July 3, 2007
Last Verified: July 2007

Keywords provided by Vanderbilt University:
Growth Hormone
Cardiovascular System

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs