Growth Hormone's Effect on the Cardiovascular System

This study has been 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.)
Sponsor:
Collaborators:
Pfizer
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00397319
First received: November 8, 2006
Last updated: July 2, 2007
Last verified: July 2007
  Purpose

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 Intervention
Growth Hormone Deficiency
Drug: Growth Hormone

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Longitudinal
Official Title: The Role of Growth Hormone in Cardiovascular Health

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Estimated Enrollment: 26
Study Start Date: August 2005
Study Completion Date: December 2006
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397319

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Pfizer
Investigators
Principal Investigator: Doug Vaughan, MD Vanderbilt University
  More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00397319     History of Changes
Other Study ID Numbers: 050045, 1422
Study First Received: November 8, 2006
Last Updated: July 2, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Growth Hormone
Cardiovascular System

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

ClinicalTrials.gov processed this record on September 18, 2014