Weight Management in Nonalcoholic Steatohepatitis

Fatty Liver Clinical Trial

Official title: Weight Management in Nonalcoholic Steatohepatitis (NASH)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 has never been a randomized controlled trial evaluating 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 liver histology. The objective of this project is to conduct a pilot study in preparation for a randomized controlled trial of weight reduction in the management of NASH. In this study, 30 overweight or obese individuals with biopsy-proven NASH will be enrolled. Twenty patients will be randomized to receive 48 weeks of intensive weight management using a combination of diet, exercise and behavior modification with a goal of 7-10% weight reduction. This weight loss program is similar to programs used successfully in other overweight populations and to the intensive lifestyle program of the Diabetes Prevention Program and Look AHEAD. The other 10 patients will be randomized to a control group where they will receive standard medical care and general counseling on healthy eating and exercise. At the end of the 48-week study, patients will have a repeat liver biopsy that will be compared to their baseline biopsy. The pilot study will establish the feasibility of recruiting and retaining, producing sustained weight loss and performing repeat liver biopsies in this population. Based on the outcomes of this preliminary trial, this program will be further refined and readied for a larger-scale clinical trial. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver

• NCT number: NCT00266019
• Study type: Interventional
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Status: Completed
• Phase: Phase 2
• Start date: January 2005
• Completion date: December 2007