PIOGLITAZONE IN HEP C: A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY

该子项目是利用 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来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 有几项研究将丙型肝炎患者脂肪肝的存在与肝脏中瘢痕形成或疾病进展的数量联系起来。这种脂肪在肝脏中的积累可能是由于胰岛素抵抗。在这项研究中，我们想测试接受FDA批准的糖尿病药物吡格列酮（或Actos）治疗的患者是否会： A. 帮助减少胰岛素抵抗，这已被证明是导致非酒精性脂肪肝患者脂肪肝的关键因素。 B。 评估药物治疗期间肝脏中的脂肪量是否有所改善，这可能会改善肝脏中的纤维化（或瘢痕形成）量。 C. 发现如果患者正在接受艾可拓沿着与已建立的联合治疗，利巴韦林和干扰素，将更好地整体响应，治疗丙型病毒性肝炎。 我们计划进行一项双盲、安慰剂对照研究，其中受试者将接受正常的48周丙型肝炎治疗，以及研究药物（吡格列酮或安慰剂）治疗，并在研究治疗前和48周治疗结束时进行肝脏组织学评价，以评估组织学改善。 '

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. There have been several studies that link the presence of fatty liver in patients with viral hepatitis C and the amount of scarring or disease progression in the liver. This accumulation of fat in the liver may be due to insulin resistance. In this study, we would like to test whether patients treated with an FDA approved drug for diabetes, Pioglitazone (or Actos) will: A. Help reduce insulin resistance, which has been shown to be a key factor in causing fatty liver in patients with non-alcoholic fatty liver disease. B. Assess whether the amount of fat in the liver improves during drug treatment, which may improve the amount of fibrosis (or scarring) in the liver. C. Discover if patients being treated with Actos along with the established combination therapy, Ribaviron and Interferon, will respond better overall, to treatment for viral hepatitis C. We plan to conduct a double-blind, placebo controlled study where the subject will undergo the normal 48 weeks of treatment for hepatitis C, in addition to the study medication (pioglitazone or placebo) with histologic evaluation of the liver before treatment and at the end of 48 weeks of therapy in the study in order to assess histologic improvement. '