Lovaza® and Microvascular Function in Type 2 Diabetes
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to determine the efficacy of 6 months of 4 g/day oral Lovaza®
on endothelial-dependent and heat-induced vasodilation in type 2 diabetics with neuropathy
and elevated triglyceride levels. Omega-3 fatty acids appear to exert beneficial effects on
vascular function that are independent of the changes in serum triglycerides. The efficacy
will be compared with a placebo given at the same duration. Efficacy of the drug will be
evaluated after 3 and 6 months of treatment. This timeline should be adequate for evaluation
of the primary neurophysiological endpoints. Previously, the investigators have demonstrated
that it is feasible to pharmacologically alter nerve fiber density in as little as 18 weeks
and that this correlates with subjective and objective measures of neurovascular function.
The investigators are predicting an enhancement of post-ischemic hyperemia of the foot
dorsum, where the dilative mechanism is primarily endothelium-dependent and a similar
improvement in heat-induced hyperemia.