Weight Management (diet, exercise, and behavior modification) in Fatty Liver - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Fatty Liver

Intervention / Treatment

Behavioral: Weight Management (diet, exercise, and behavior modification)

Detailed 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 Type

Interventional

Enrollment (Anticipated)

30

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

< 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Liver histology score (NASH-Clinical Research Network [CRN] scoring system) at 48 weeks
Weight reduction at 48 weeks

Secondary Outcome Measures

Outcome Measure
Insulin sensitivity at 48 weeks
Liver function test at 48 weeks
Inflammatory markers and adipokine levels at 48 weeks
Quality of life at 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

Principal Investigator: Kittichai Promrat, M.D., Rhode Island Hospital/Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 14, 2005

First Submitted That Met QC Criteria