Fatty Liver Clinical Trial
Official title:
Weight Management in Nonalcoholic Steatohepatitis (NASH)
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Rhode Island Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Bacon BR, Farahvash MJ, Janney CG, Neuschwander-Tetri BA. Nonalcoholic steatohepatitis: an expanded clinical entity. Gastroenterology. 1994 Oct;107(4):1103-9. — View Citation
Kleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. — View Citation
Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. — View Citation
Ludwig J, Viggiano TR, McGill DB, Oh BJ. Nonalcoholic steatohepatitis: Mayo Clinic experiences with a hitherto unnamed disease. Mayo Clin Proc. 1980 Jul;55(7):434-8. — View Citation
Ueno T, Sugawara H, Sujaku K, Hashimoto O, Tsuji R, Tamaki S, Torimura T, Inuzuka S, Sata M, Tanikawa K. Therapeutic effects of restricted diet and exercise in obese patients with fatty liver. J Hepatol. 1997 Jul;27(1):103-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver histology score (NASH-Clinical Research Network [CRN] scoring system) at 48 weeks | |||
Primary | Weight reduction at 48 weeks | |||
Secondary | Insulin sensitivity at 48 weeks | |||
Secondary | Liver function test at 48 weeks | |||
Secondary | Inflammatory markers and adipokine levels at 48 weeks | |||
Secondary | Quality of life at 48 weeks |
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