Obesity and Nonalcoholic Fatty Liver Disease

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Fenofibrate; Liver Extracts; Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

All

• 18 - 45 years old

• Class I obesity, i.e. Body Mass Index (BMI) between 30 and 45.

• weight less than 300 lbs.

Exclusion Criteria:

• Active or previous infection with hepatitis B or C, as well as other liver disease.

• History of alcohol abuse

• Diabetes

• Medications that cause liver damage or steatosis.

• Women who are pregnant or lactating.