This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The principal objective of this study is to evaluate if 96 weeks of treatment with an insulin sensitizer (pioglitazone 30 mg q.d.) or Vitamin E (800 IU q.d.) vs placebo would lead to an improvement in hepatic histology in non-diabetic patients over the age of 18 with nonalcoholic steatohepatitis (NASH). Secondary outcome measures include change in serum aminotransferase levels, change in anthropometric measurements, change in insulin resistance, change in serum vitamin E levels, and change in health related quality of life scores. There will be a 120 week follow-up visit. Subjects will have a liver biopsy before and at the conclusion of blinded therapy. Subjects will undergo anthropometric assessments including a DEXA scan, provide blood for laboratory assessments and banking, complete questionnaires (nutritional, health-related quality of life, life-time drinking history, functional activity and liver symptoms). A standard 75 gm. OGTT will be administered. Target accrual is 348 patients.
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