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

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。 在非糖尿病成年NASH患者中确定，与安慰剂治疗相比，服用吡格列酮治疗96周以上的胰岛素抵抗的改善是否会导致NASH疾病活动的改善，这是通过包括脂肪变性、小叶炎症和细胞气球的组织学评分来评估的。确定在非糖尿病NASH患者中，与安慰剂治疗相比，使用维生素E治疗超过96周的氧化应激状态的改善是否会改善肝脏内的脂质过氧化水平，并将导致NASH疾病的改善，这是通过包括脂肪炎、小叶炎和细胞气球的组织学评分来评估的。如果服用吡格列酮和维生素E的糖尿病患者的促炎细胞因子、血清脂质过氧化标志物和血清纤维化标志物的水平与安慰剂治疗相比会降低，以及非糖尿病的成年NASH患者的生活质量是否受损，确定吡格列酮和维生素E在实现糖尿病NASH患者的组织学改善方面是否同样有效，并且与安慰剂治疗相比，随着他们的肝脏组织学改善，这些评分将得到改善。

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. 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.