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Sponsors and Collaborators: |
St. Louis University Hoffmann-La Roche |
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Information provided by: | St. Louis University |
ClinicalTrials.gov Identifier: | NCT00160407 |
The purpose of this study is to determine if orlistat (Xenical) therapy in overweight patients with NASH leads to enhanced weight loss over time, with subsequent improvement in the underlying necroinflammatory and fibrotic changes that are typical of NASH.
Condition | Intervention | Phase |
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Fatty Liver Hepatitis |
Drug: Orlistat (Xenical) Behavioral: 1400 kcal diet (30% fat) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH) |
Estimated Enrollment: | 50 |
Study Start Date: | October 2003 |
Study Completion Date: | December 2006 |
Previous studies have suggested that steady weight loss over time will result in improvement in aminotransferases, and more importantly, underlying histopathology in patients with NASH. A total of 50 biopsy-proven NASH patients will be enrolled in a prospective, randomized fashion. Twenty-five patients have been enrolled at the primary study site at Saint Louis University. Recruitment of the next 25 patients is taking place at a study subsite at Brooke Army Medical Center in San Antonio, Texas.
This will be an open-label study comparing an established weight loss program (1400-calorie diet with 30% fat) plus daily vitamin E (800 IU) and a daily multivitamin to the same weight loss program, daily vitamin E (800 IU) and multivitamin, plus orlistat (120 mg), three times daily for 36 weeks.
Data to be collected from prospective patients includes demographic information, such as age, sex, past medical history, medications, height and weight. Biochemical data to be collected from prospective patients includes liver enzymes, measures of insulin resistance to include, insulin levels, lipid panel, hemoglobin A1C, free fatty acids, complete blood count, coagulation studies, and vitamin E levels. Blood will also be collected and stored for markers of inflammation and fibrosis, such as C reactive protein and TNF-alpha. A liver biopsy will be obtained at the completion of the study for both histopathologic analysis and RNA analysis.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Compensated liver disease with the following laboratory parameters at the entry visit:
Exclusion Criteria:
United States, Missouri | |
Saint Louis University | |
St. Louis, Missouri, United States, 63110 | |
United States, Texas | |
Brooke Army Medical Center | |
San Antonio, Texas, United States, 78234 |
Principal Investigator: | Brent A Tetri, MD | St. Louis University |
Study ID Numbers: | 12458, XEN185 |
Study First Received: | September 8, 2005 |
Last Updated: | November 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00160407 |
Health Authority: | United States: Institutional Review Board |
nonalcoholic steatohepatitis enzyme inhibitors lipase obesity insulin resistance |
Hepatitis Obesity Orlistat Liver Diseases Non-alcoholic steatohepatitis (NASH) |
Digestive System Diseases Overweight Fatty Liver Insulin Resistance Insulin |
Anti-Obesity Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Central Nervous System Agents Pharmacologic Actions |