Fatty Liver Clinical Trial
Official title:
Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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