Weight Management in Nonalcoholic Steatohepatitis

Completed · Phase 2

Conditions studied: Fatty Liver

In brief

Nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases. The cause of NASH is not completely understood and currently there is no effective treatment for this disease. An effective approach to treatment is needed since without treatment this disease may progress to fibrosis and cirrhosis. Obesity is one of the most important risk factors for NASH and weight reduction is generally recommended as an initial step in its management. However, there are very limited data on the efficacy of weight reduction as a treatment for NASH. Data from uncontrolled trials using poorly defined primary outcome measures and patient populations and nonstandardized weight loss interventions suggest that modest weight loss may improve fatty liver disease. The objective of this project is to conduct a randomized controlled trial of weight reduction in the management of NASH using a combination of diet, exercise, and behavior modification.

Key facts

Study ID

NCT00266019

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

30

Starts

2005-01-01

Expected to finish

2007-12-01

Last updated by the study team

2010-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Evidence of chronic steatohepatitis on liver biopsy.
• Elevated alanine or aspartate aminotransferase values (ALT > 41 or AST > 34) within 3 months of enrollment
• Absence of another form of liver disease
• Body mass index between 25-50 kg/m2.
• At least 18 years of age
• Absence of significant alcohol consumption (more than one standard drink per day).
• Able to walk 2 blocks or a quarter of a mile without stopping
• Willing to complete a two-week run-in period with successful completion of self-monitoring records.

You may not qualify if…

• < 18 years of age
• Significant alcohol consumption (> 1 standard drink per day)
• Contraindications to obtaining a liver biopsy
• Unable to walk 2 blocks or a quarter of a mile without stopping
• Currently pregnant or pregnant in the previous six months
• Currently engaged in an active weight-loss program or taking weight-loss medication
• Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol for 12 months, including illness likely to be terminal within 2 years, plans to move, substance abuse, or other significant psychiatric problems

Where it is running

• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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