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

吡格列酮与维生素 E 与安慰剂治疗非糖尿病患者的比较

• 批准号: 7606423
• 负责人: NAGA P CHALASANI
• 金额: $ 3.88万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606423
• 关键词: Antioxidants; Chronic; Cirrhosis; Clinical; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Data; Data Coordinating Center; Diabetes Mellitus; End Point; Enrollment; Epidemic; Event; Funding; Grant; Hepatotoxicity; Hypoglycemia; Incidence; Indiana; Individual; Institution; Insulin Resistance; Liver Failure; Liver diseases; Masks; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Obesity; Outcome; Oxidative Stress; Pathogenesis; Patients; Pioglitazone; Placebos; Play; Pregnancy; Primary carcinoma of the liver cells; Public Health Schools; Randomized; Research; Research Personnel; Resources; Risk Factors; Role; Safety; Sample Size; Score; Source; Time; United States National Institutes of Health; Universities; Vitamin E; Vitamins; Week; insulin sensitizing drugs; liver biopsy; non-diabetic; nonalcoholic steatohepatitis; patient oriented; placebo controlled study

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 非酒精性脂肪性肝炎 (NASH) 是一种慢性肝脏疾病，可进展为肝硬化、肝功能衰竭和肝细胞癌。发生 NASH 的最重要的危险因素之一是肥胖。由于肥胖症的持续流行，NASH的发病率正在迅速增加。目前，NASH 尚无行之有效的治疗方法。迄今为止的研究表明，胰岛素抵抗和氧化应激在 NASH 的发病机制中发挥着重要作用。 NASH 临床研究网络 (NASH CRN) 是 NIH 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 提议开展 PIVENS 试验，这是一项多中心、随机双盲、安慰剂对照研究，旨在评估吡格列酮（胰岛素增敏剂）或维生素 E（抗氧化剂）给药 96 周治疗非糖尿病个体 NASH 的疗效。主要终点是 NASH 活动的改善，定义为基线时和治疗 96 周后肝活检标准化评分的变化。总样本量为 240 名患者，该中心最多可招募 50 名患者。所有统计分析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 将监测肝毒性、低血糖、妊娠、新发糖尿病以及任何其他被确定为安全相关的结果或事件等结果的安全性和有效性数据。