A Phase 4 interventional study of Orlistat (Xenical) and 1400 kcal diet (30% fat) in Fatty Liver and Hepatitis, sponsored by St. Louis University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-20.
Sponsored by St. Louis University · Phase 4, Interventional, and Treatment
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.
1,462 studies on the registry are indexed under Fatty Liver; 289 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 1,009 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →St. Louis University is the lead sponsor of 156 studies on the registry; 17 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Compensated liver disease with the following laboratory parameters at the entry visit:
Exclusion Criteria:
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)
The record gives a start of Oct 2003 and a completion of Dec 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Orlistat