At a glance
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Obesity and Nonalcoholic Fatty Liver Disease
In Brief
A clinical study evaluating Niacin, fenofibrate, and 1 other intervention for Non-alcoholic Fatty Liver Disease. Completed, enrolled 51 participants across 1 site.
Detailed Summary
The primary goal of this study is to provide a better understanding of: 1) the pathogenesis and pathophysiology of non-alcoholic fatty liver disease (NAFLD) in obese subjects, and 2) the effect of marked weight loss on the histologic and metabolic abnormalities associated with NAFLD. The following hypotheses will be tested: 1. obesity causes hepatic fat accumulation because of excessive fatty acid release from fat tissue and increased free fatty acid availability, 2. increased hepatic (liver) fat content causes insulin-resistant glucose (sugar) production by the liver and altered liver protein synthesis, 3. increased hepatic fat content causes increased lipid (fat) peroxidation, hepatic inflammation, necrosis and fibrosis, and 4. marked weight loss improves NAFLD once patients are weight stable.
Study Details
Timeline
Interventions
Subjects randomized to Niacin therapy will be treated with Niacin at night for 16 wks to reduce plasma free fatty acid concentrations. The dose of medication will be gradually increased: 500 mg/day during week 1, 1000 mg/day during week 2, 1500 mg/day during week 3, and 2000mg/day during weeks 4-16.
Subjects randomized to fenofibrate will be treated with 200 mgs per day for eight weeks.
Subjects randomized to placebo will be treated with one placebo pill per day for eight weeks.