Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)
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|ClinicalTrials.gov Identifier: NCT00160407|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : November 20, 2007
|Condition or disease||Intervention/treatment||Phase|
|Fatty Liver Hepatitis||Drug: Orlistat (Xenical) Behavioral: 1400 kcal diet (30% fat)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)|
|Study Start Date :||October 2003|
|Actual Study Completion Date :||December 2006|
- The primary endpoint is weight loss leading to improvement in the global necroinflammatory and fibrosis scores on liver biopsies. A change of one point in the necroinflammatory grade or fibrosis stage will be considered statistically significant.
- BMI,ALT,Serum free fatty acids,HOMA-IR (fasting insulin x fasting glucose/22.4)
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): NCT00160407
|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|