At a glance
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Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk
In Brief
A Phase 3 clinical trial evaluating Salsalate and Placebo for Atherosclerosis and 4 related conditions. Completed, enrolled 71 participants across 1 site.
Detailed Summary
The hypothesis is that salsalate therapy may be an effective and safe method to modulate inflammation in metabolically-critical tissues and thus reduce insulin resistance and its related complications. The objectives of the study are to (1) determine whether salsalate therapy improves insulin resistance in subjects with IGT and changes in glucose area under the curve following a standard oral glucose tolerance test (OGTT); (2) determine whether salsalate therapy reduces a) plasma levels of a variety of well established inflammatory proteins and b) mononuclear cell inflammatory activity to provide evidence of reduced systemic and tissue inflammation, respectively; and (3)also determine whether salsalate therapy improves parameters of cardiovascular disease risk, including features of metabolic syndrome (fasting glucose, triglycerides, HDL, and blood pressure) as well as endothelial dysfunction.
Study Details
Timeline
Interventions
Participants were randomized to 12-week treatment with up to 4 g/day.
Participants were randomized to 12-week treatment matching the active salsalate arm.