TREATMENT OF NONALCOHOLIC STEATOHEPATITIS (PIVENS)

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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. Nonalcoholic steatohepatitis (NASH) is a common liver disease which can ultimately lead to cirrhosis, hepatocellular carcinoma and end-stage liver disease. NASH is most common in adults above the age of 40 who are overweight or have diabetes, insulin resistance or hyperlipidemia. However, the disease also occurs in children and in persons who are not obese or diabetic. NASH is included under a classification of liver diseases known as nonalcoholic fatty liver disease (NAFLD). The spectrum of NAFLD includes simple steatosis, steatosis with inflammation, and what is currently referred to as nonalcoholic steatohepatitis (NASH). Currently, there are no effective therapies for NASH, and its natural history and prognosis are not well understood. In response to the lack of clear understanding of the pathogenesis of NASH, its natural history, prognostic features, and treatment, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has funded a Clinical Research Network to study the natural history, pathogenesis and therapy of NASH. This is a multi-center, randomized, double-masked, placebo-controlled clinical trial evaluating treatment with pioglitazone (an insulin sensitizing agent used for diabetes mellitus) or vitamin E for nondiabetic patients with NASH. Approximately 240 patients will be recruited from eight clinical centers over a two year period with each center enrolling approximately 30 patients. Primary endpoints of the study will include improvement of NASH activity defined from change in standardized scoring of liver biopsies (at baseline and after 96 weeks of treatment).