TREATMENT OF NONALCOHOLIC STEATOHEPATITIS (PIVENS)

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。非酒精性脂肪性肝炎(NASH)是一种常见的肝病，最终可导致肝硬变、肝细胞癌和终末期肝病。NASH最常见于40岁以上的成年人，他们超重或患有糖尿病、胰岛素抵抗或高脂血症。然而，这种疾病也会发生在儿童和非肥胖或糖尿病的人身上。NASH被列入被称为非酒精性脂肪性肝病(NAFLD)的肝病分类。NAFLD的范围包括单纯性脂肪变性、脂肪变性合并炎症，以及目前被称为非酒精性脂肪性肝炎(NASH)。目前，NASH尚无有效的治疗方法，其自然病程和预后尚不清楚。由于对NASH的发病机制、自然病史、预后特征和治疗缺乏明确的认识，美国国家糖尿病、消化和肾脏疾病研究所(NIDDK)资助了一个临床研究网络，以研究NASH的自然历史、发病机制和治疗。这是一项多中心、随机、双掩蔽、安慰剂对照的临床试验，评估非糖尿病NASH患者使用吡格列酮(一种用于糖尿病的胰岛素增敏剂)或维生素E的治疗效果。在两年的时间里，将从8个临床中心招募大约240名患者，每个中心招募大约30名患者。这项研究的主要终点将包括根据肝活检标准化评分的变化(基线和治疗96周后)确定的NASH活性的改善。

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).