Growth Hormone's Effect on the Cardiovascular System
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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 Time Perspective: Prospective |
| Official Title: | The Role of Growth Hormone in Cardiovascular Health |
| Estimated Enrollment: | 26 |
| Study Start Date: | August 2005 |
| Study Completion Date: | December 2006 |
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 |
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| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| 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 Endocrine System Diseases 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 Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013