Inflammation Clinical Trial
Official title:
Role of Adenosine in the Release of VEGF and Cytokines
The purpose of this study is to extend previous observations in animal models regarding the effects of adenosine in the release of cytokines to human subjects. We intend to accomplish this in two study protocols. In the first we will infuse intravenously adenosine and measure the plasma levels of inflammatory cytokines. In the second one, we will use a microdialysis technique to infuse intradermally small amounts of adenosine and will measure skin blood flow and will take a biopsy to measure levels of mRNA for cytokines.
In Protocol 1 we will infuse adenosine at a dose of 80 mcg/kg/min for 30 minutes while
measuring plasma levels of adenosine at different time points, ranging from 30 minutes to 6
hours. Because activation of A2B receptors also mediates the release of inflammatory
cytokines, including IL-6, samples will be taken to measure these and other
inflammatory/angiogenic cytokines.
In a second protocol, we will administer adenosine intradermically via a microdialysis probe
for 30 minutes while we measure the local effect on skin blood flow using laser Doppler
techniques. One hour after the end of the infusion we will obtain a skin biopsy from the
perfused area for measurement of mRNA for VEGF, IL-8, IL-6 and other cytokines. In addition,
we foresee the possibility of further testing looking for and genetic association between
angiogenesis and adenosine.
These are proof-of-concept pilot studies. We will study up to 12 subjects in each protocol
but an interim analysis will be performed after 6 subjects are studied. This will help us
determine if a trend is observed, to perform power calculations, and determine if more
extensive studies are warranted.
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