Weight Management in Nonalcoholic Steatohepatitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00266019 |
Recruitment Status :
Completed
First Posted : December 15, 2005
Last Update Posted : January 13, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fatty Liver | Behavioral: Weight Management (diet, exercise, and behavior modification) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Weight Management in Nonalcoholic Steatohepatitis (NASH) |
Study Start Date : | January 2005 |
Actual Study Completion Date : | December 2007 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266019
United States, Rhode Island | |
Rhode Island Hospital | |
Providence, Rhode Island, United States, 02903 |
Principal Investigator: | Kittichai Promrat, M.D. | Rhode Island Hospital/Brown University |
ClinicalTrials.gov Identifier: | NCT00266019 |
Other Study ID Numbers: |
DK67363 (completed) |
First Posted: | December 15, 2005 Key Record Dates |
Last Update Posted: | January 13, 2010 |
Last Verified: | January 2010 |
nonalcoholic steatohepatitis nonalcoholic fatty liver disease Fatty liver Cirrhosis |
Obesity Weight Reduction Weight Management |
Fatty Liver Non-alcoholic Fatty Liver Disease Liver Diseases Digestive System Diseases |