ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| 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 | |||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Not Provided | |||
| Study Population | Not Provided | |||
| Condition | Growth Hormone Deficiency | |||
| Intervention | Drug: Growth Hormone | |||
| Study Groups/Cohorts | Not Provided | |||
| Publications * | 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Terminated | |||
| Enrollment | 26 | |||
| Original Enrollment | Same as current | |||
| Actual Study Completion Date | December 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | Yes | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00397319 | |||
| Other Study ID Numbers | 050045 1422 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor | Vanderbilt University | |||
| Collaborators |
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| Investigators |
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| PRS Account | Vanderbilt University | |||
| Verification Date | July 2007 | |||