drugset / Trial / NCT00262964

Obesity and Nonalcoholic Fatty Liver Disease

NCT00262964

RandomizedFactorialSingle-blindTreatment

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.

Timeline

Start
2004-10
Primary completion
2008-12
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenofibrate Small molecule 200 mg Oral
Subject Niacin Small molecule 2000 mg

Indications