CLINICAL TRIAL: PIOGLITAZONE VS VITAMIN E VS PLACEBO FOR NONALCOHOLIC STEATOHEPA

临床试验：吡格列酮 VS 维生素 E VS 安慰剂治疗非酒精脂肪肝

基本信息

批准号：
7950927
负责人：
JOEL Edward LAVINE
金额：
$ 2.55万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-12-01 至 2009-11-30
项目状态：
已结题

项目摘要

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. Determine in nondiabetic adult patients with NASH if improvement in insulin resistance over 96 weeks of treatment with pioglitazone compared to treatment with placebo will result in improvement in NASH disease activity as assessed by a histologic score comprised of steatosis, lobular inflammation and cellular ballooning. Determine in nondiabetic patients with NASH if improvement in oxidative stress status over 96 weeks of treatment with vitamin E compared to treatment with placebo will inprove intrahepatic levels of lipid peroxidations and will result in improvement in NASH disease as assessed by a histologic score comprised of steatostis, lobular inflammation and cellular ballooning. Determine if pioglitazone and vitamin E are equally effective in achieving histologic improvement in diabetic patients with NASH, if levels of proinflammatory cytokines, serum markers of lipid peroxidation, and serum markers for fibrosis will decrease with treatment with pioglitazone and with vitamin E compared to treatment with placebo, and if nondiabetic adult patients with NASH have an impaired quality of life, and these scores will improve as their liver histology improves upon treatment with pioglitazone or vitamin E, compared to treatment with placebo.

该副本是利用众多研究子项目之一由NIH/NCRR资助的中心赠款提供的资源。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构是对于中心，这不一定是调查员的机构。与安慰剂治疗相比，在96周的胰岛素耐药性治疗中，胰岛素抵抗的改善是否会改善NASH疾病活动的改善，该组织学评分由脂肪变性，小叶炎症和细胞气囊评估。确定NASH的非糖尿病患者是否在96周的维生素E治疗中与安慰剂治疗相比，氧化应激状态的改善将内化肝内脂质过氧化的水平，并将导致NASH疾病的改善，这是由脂肪症，小叶炎症和细胞炎症和细胞弹药组成的组织学评分所评估的。 Determine if pioglitazone and vitamin E are equally effective in achieving histologic improvement in diabetic patients with NASH, if levels of proinflammatory cytokines, serum markers of lipid peroxidation, and serum markers for fibrosis will decrease with treatment with pioglitazone and with vitamin E compared to treatment with placebo, and if nondiabetic adult patients with NASH have an impaired quality of life, and与安慰剂的治疗相比，随着肝酮或维生素E治疗后，这些分数将改善。