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.

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。子项目和 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。 确定患有 NASH 的非糖尿病成年患者，与安慰剂治疗相比，吡格列酮治疗 96 周后胰岛素抵抗的改善是否会导致 NASH 疾病活动性的改善（通过由脂肪变性、小叶炎症和细胞膨胀组成的组织学评分进行评估）。确定非糖尿病 NASH 患者与安慰剂治疗相比，维生素 E 治疗 96 周后氧化应激状态的改善是否会提高肝内脂质过氧化水平，并导致 NASH 疾病的改善（通过由脂肪组织、小叶炎症和细胞气球样化组成的组织学评分进行评估）。 确定吡格列酮和维生素 E 在实现 NASH 糖尿病患者的组织学改善方面是否同样有效，与安慰剂治疗相比，使用吡格列酮和维生素 E 治疗时促炎细胞因子、血清脂质过氧化标志物和血清纤维化标志物的水平是否会降低，以及非糖尿病成年 NASH 患者的生活质量是否受损，以及 与安慰剂治疗相比，吡格列酮或维生素 E 治疗后，随着肝脏组织学的改善，这些分数将会提高。