Hypertriglyceridemia Clinical Trial
Official title:
The Role of Lovaza® on Microvascular Function and Lipoprotein Profile in Type 2 Diabetes
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.
This pilot study is a within-subject repeated measures design. This study will compare the
neurophysiological and vascular responses to placebo and treatment with Lovaza®
(omega-3-acid ethyl esters, Reliant Pharmaceuticals, Inc.) in subjects with type 2 diabetes,
neuropathy, and dyslipidemia.
Lovaza's potential mechanism of action is the inhibition of acyl CoA:1, 2-diacylglycerol
acyltransferase and increased peroxisomal β-oxidation in the liver.
Subjects will be recruited and a baseline of physiological, neurological and hematological
profile established for each patient. Forty-four subjects (20 in the active arm, 20 in the
placebo arm, and 2 replacements for each arm) will receive 4 g/day Lovaza® tablets or
placebo for a period of 6 months. All subjects will receive a physical and neurological exam
as well as neurovascular function testing. This includes nerve conduction studies,
quantitative sensory testing, quantitative autonomic testing, and skin blood flow testing,
which includes, ischemia reperfusion. Lab tests include an insulin resistance profile,
hepatic and renal function profiles, lipid profile, C-reactive protein, thyroid stimulating
hormone, and fatty acids. Other tests include inflammatory markers such as adiponectin and
TNF-α. The study is powered to detect differences in microvascular function after 6 months
of Lovaza® and differences in ethnic responses.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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