TREATMENT OF NONALCOHOLIC STEATOHEPATITIS (PIVENS)

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。非酒精性脂肪性肝炎（NASH）是一种常见的肝脏疾病，最终可导致肝硬化、肝细胞癌和终末期肝病。NASH最常见于40岁以上超重或患有糖尿病、胰岛素抵抗或高脂血症的成年人。然而，这种疾病也发生在儿童和非肥胖或糖尿病患者身上。NASH属于一种被称为非酒精性脂肪性肝病（NAFLD）的肝脏疾病。NAFLD包括单纯性脂肪变性、炎症性脂肪变性和目前所称的非酒精性脂肪性肝炎（NASH）。目前，NASH还没有有效的治疗方法，其自然史和预后也不清楚。由于对NASH的发病机制、自然史、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，研究NASH的自然史、发病机制和治疗。这是一项多中心、随机、双盲、安慰剂对照临床试验，评估吡格列酮（一种用于糖尿病的胰岛素增敏剂）或维生素E对非糖尿病NASH患者的治疗效果。在两年的时间里，将从8个临床中心招募约240名患者，每个中心招募约30名患者。该研究的主要终点将包括肝活检标准化评分变化所定义的NASH活动度的改善（基线和治疗96周后）。

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).