An interventional study of Growth Hormone in Cardiovascular Disease, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-07-03.
Sponsored by Vanderbilt University · Not applicable and Interventional
To assess the effect of short-term low-dose growth hormone therapy on the mobilization of endothelial progenitor cells from the bone marrow within a group of healthy adults.
We are proposing a pilot study to assess the effect of the administration of recombinant human growth hormone on the number of endothelial progenitor cells (EPC's) in the peripheral circulation. An increase in the number of EPC's is viewed as beneficial, as it has been postulated that they provide an endogenous repair mechanism to counteract endothelial injury. Additionally, a reduced number of EPC's has been found to independently predict atherosclerotic disease progression. Mechanisms proposed for enhancing the number of circulating EPC's and their function include an increase in proliferation, mobilization from the bone marrow, or prevention of EPC apoptosis. Thus, a pharmacologic manipulation of the number of EPC's in the peripheral circulation could potentially serve as a mechanism by which endothelial function, and thus vascular health, may be improved.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 18 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Number of Endothelial Progenitor Cells per mm^2 in culture after a maximum of 8 weeks of growth hormone therapy or until somatomedin-C is in the upper quartile of the normal range, as compared to baseline.
All outcome measures will be assessed at baseline and following either a maximum of 8 weeks of growth hormone therapy or until somatomedin-C is in the upper quartile of the normal range:CD34/KDR+ Endothelial Progenitor Cells
Plasma nitrite and nitrate
L-Arginine
ADMA
estradiol
erythropoietin
SDF-1
VEGF
This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
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Vanderbilt University