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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 非酒精性脂肪性肝炎(NASH)是一种慢性肝病，可进展为肝硬化、肝功能衰竭和肝细胞癌。患NASH最重要的风险因素之一是肥胖。由于肥胖的持续流行，NASH的发病率正在迅速增加。目前，还没有经过验证的治疗NASH的方法。到目前为止的研究表明，胰岛素抵抗和氧化应激在NASH的发病机制中起着重要作用。NASH临床研究网络(NASH CRN)是由美国国立卫生研究院资助的网络，成立于2002年，印第安纳大学是其临床中心之一。NASH CRN正在提议进行Pivens试验，这是一项多中心、随机、双掩蔽、安慰剂对照研究，评估服用96周的吡格列酮(胰岛素增敏剂)或维生素E(抗氧化剂)治疗非糖尿病患者的NASH的疗效。主要终点是NASH活性的改善，根据基线和治疗96周后肝活检标准化评分的变化确定。总样本量为240名患者，该中心最多可招收50名患者。所有的统计分析都将由约翰霍普金斯大学公共卫生学院的数据协调中心完成。NIDDK指定的DSMB将监测数据的安全性和有效性，以评估肝毒性、低血糖、妊娠、新发糖尿病以及任何其他与安全相关的结果或事件。

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.