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

• 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
• 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
• 来源: https://reporter.nih.gov/project-details/7950927
• 关键词: Adult; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Disease; Fibrosis; Funding; Grant; Histologic; Histology; Inflammation; Institution; Insulin Resistance; Lipid Peroxidation; Liver; Lobular; Oxidative Stress; Patients; Pioglitazone; Placebos; Quality of life; Research; Research Personnel; Resources; Serum Markers; Source; United States National Institutes of Health; Vitamin E; cytokine; diabetic patient; improved; intrahepatic; non-alcoholic; non-diabetic; nonalcoholic steatohepatitis

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 通过由脂肪变性、小叶炎症和细胞气球样变组成的组织学评分评估，确定在非糖尿病成人NASH患者中，与安慰剂治疗相比，吡格列酮治疗96周期间胰岛素抵抗的改善是否会导致NASH疾病活动性的改善。确定在非糖尿病NASH患者中，与安慰剂治疗相比，维生素E治疗96周后氧化应激状态的改善是否会改善肝内脂质过氧化水平，并通过由脂肪变性、小叶炎症和细胞气球样变组成的组织学评分评估导致NASH疾病的改善。 确定吡格列酮和维生素E在NASH糖尿病患者中实现组织学改善方面是否同样有效，与安慰剂治疗相比，吡格列酮和维生素E治疗是否会降低促炎性细胞因子、脂质过氧化血清标志物和纤维化血清标志物的水平，以及非糖尿病NASH成人患者的生活质量是否受损，与安慰剂治疗相比，这些评分将随着吡格列酮或维生素E治疗后肝脏组织学的改善而改善。