Weight Management in Nonalcoholic Steatohepatitis

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00266019
First received: December 14, 2005
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Fatty Liver
Behavioral: Weight Management (diet, exercise, and behavior modification)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weight Management in Nonalcoholic Steatohepatitis (NASH)

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: January 2005
Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. < 18 years of age
  2. Significant alcohol consumption (> 1 standard drink per day)
  3. Contraindications to obtaining a liver biopsy
  4. Unable to walk 2 blocks or a quarter of a mile without stopping
  5. Currently pregnant or pregnant in the previous six months
  6. Currently engaged in an active weight-loss program or taking weight-loss medication
  7. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266019

Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Investigators
Principal Investigator: Kittichai Promrat, M.D. Rhode Island Hospital/Brown University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00266019     History of Changes
Other Study ID Numbers: DK67363 (completed)
Study First Received: December 14, 2005
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
nonalcoholic steatohepatitis
nonalcoholic fatty liver disease
Fatty liver
Cirrhosis
Obesity
Weight Reduction
Weight Management

Additional relevant MeSH terms:
Fatty Liver
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 22, 2014