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

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。 已经有几项研究表明，丙型肝炎患者脂肪肝的存在与肝脏瘢痕形成或疾病进展的数量有关。这种脂肪在肝脏中的堆积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： 答：有助于降低胰岛素抵抗，这已被证明是导致非酒精性脂肪性肝病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，这可能会改善肝脏的纤维化(或疤痕)数量。 C.发现在已有的联合疗法利巴韦隆和干扰素的同时，接受Actos治疗的患者对丙型肝炎的治疗总体上是否会有更好的反应。 我们计划进行一项双盲、安慰剂对照研究，受试者将在研究药物(吡格列酮或安慰剂)的基础上接受常规48周的丙型肝炎治疗，并在治疗前和治疗48周结束时对肝脏进行组织学评估，以评估组织学改善情况。 ‘

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. '