PIOGLIATAZONE VERSUS VITAMIN E VERSUS PLACEBO FOR THE TREATMENT OF NON-DIABETIC

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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. Non-alcoholic steatohepatitis (NASH) is a chronic liver disorder and can progress to cirrhosis, liver failure and hepatocellular cancer. One of the most important risk factors to develop NASH is obesity. Due to the ongoing epidemic of obesity, the incidence of NASH is increasing rapidly. At the current time, there are no proven treatments for NASH. Studies done to date suggest that insulin resistance and oxidative stress play an important role in the pathogenesis of NASH. NASH Clinical Research Network (NASH CRN) is an NIH funded network that was established in 2002 and Indiana University is one of its clinical centers. NASH CRN is proposing to conduct the PIVENS trial which is a multicenter, randomized double-masked, placebo-controlled study that evaluates the efficacy of pioglitazone (insulin sensitizer) or vitamin E (antioxidant) administered for 96 weeks to treat NASH in individuals without diabetes. The primary endpoint is improvement in NASH activity defined from change in standardized scoring of liver biopsies at baseline and after 96 weeks of treatment. Total sample size is 240 patients and this center may enroll up to 50 patients. All of the statistical analyses will be done by the Data Coordinating Center at the Johns Hopkins School of Public Health. NIDDK appointed DSMB will monitor the data for safety and efficacy for outcomes such as hepatoxicity, hypoglycemia, pregnancy, new onset diabetes, and any other outcomes or events identified as safety-related.