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. )

First Received: November 8, 2006 Last Updated: July 2, 2007 History of Changes

Sponsor:	Vanderbilt University
Collaborators:	Pfizer National Center for Research Resources (NCRR)
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00397319

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:	Longitudinal, Case Control, Prospective Study
Official Title:	The Role of Growth Hormone in Cardiovascular Health

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

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

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

National Center for Research Resources (NCRR)

Investigators

Principal Investigator:

Doug Vaughan, MD

Vanderbilt University

More Information

No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2007 Jun 19.

Study ID Numbers:	050045, 1422
Study First Received:	November 8, 2006
Last Updated:	July 2, 2007
ClinicalTrials.gov Identifier:	NCT00397319 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Growth Hormone
Cardiovascular System

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Central Nervous System Diseases

Dwarfism, Pituitary
Brain Diseases
Hormones
Bone Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental

ClinicalTrials.gov processed this record on November 30, 2009