Status:
COMPLETED
Weight Management in Nonalcoholic Steatohepatitis
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Fatty Liver
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- \< 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00266019
Start Date
January 1 2005
End Date
December 1 2007
Last Update
January 13 2010
Active Locations (1)
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1
Rhode Island Hospital
Providence, Rhode Island, United States, 02903