FENOFIBRATE FOR TREATMENT OF NASH: A RANDOM, DOUBLE BLIND, PLACEBO-CTRLD 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。 非酒精性脂肪性肝炎(NASH)的特征是肝脏脂肪浸润并伴有炎症，可进展为不同程度的纤维化和肝硬化。目前还没有已知的治疗NASH的方法，尽管目前正在进行几项研究。有证据表明胰岛素抵抗是NASH脂肪肝发病的关键因素。我们假设非诺贝特的使用改善了胰岛素抵抗，降低了肝脏脂肪，改善了NASH的组织学严重程度。我们希望评估非诺贝特对NASH组织学改善的影响，并评估非诺贝特在NASH患者中的安全性。我们计划进行一项双盲、安慰剂对照研究，受试者将接受为期一年的研究药物(非诺贝特或安慰剂)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。其他测试将包括使用间接量热法的全脂氧化研究、葡萄糖耐量，以及在非诺贝特治疗前后进行DEXA扫描以评估腹部脂肪。在治疗过程中，患者将每隔一到两个月进行一次面谈和抽血，按照方案的规定进行评估。这项研究将包括所有性别和种族；有生育潜力的受试者将接受怀孕筛查。招聘将以先到先得的方式进行。研究记录将被编码并保存在一个上了锁的文件柜中，从受试者那里获得的数据将只有调查人员才能链接到。

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. Non-alcoholic steatohepatitis (NASH) is characterized by fatty infiltration of the liver accompanied by inflammation which can progress to varying degrees of fibrosis and cirrhosis. There is currently no known treatment for NASH, though several studies are being currently conducted. There is evidence that insulin resistance is a key factor in the pathogenesis of fatty liver in NASH. We hypothesize that the use of fenofibrate improves insulin resistance, decreases liver fat, and improves the histologic severity of NASH. We hope to asses the effect of fenofibrate on the histologic improvement of NASH and to assess the safety of fenofibrate in patients with NASH. We plan to conduct a double-blind, placebo controlled study where the subject will undergo a one-year treatment with the study medication (fenofibrate 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. Other tests will include whole fat oxidation using indirect calorimetry study, glucose tolerance, and a DEXA scan to assess abdominal fat before and following fenofibrate treatment. During treatment, patients will be evaluated every one to two months by interview and blood draw as indicated in the protocol. The study will include all genders and races; subjects with child bearing potential will receive pregnancy screening. Recruitment will be on a first come-first serve basis. Research records will be coded and kept in a locked file cabinet, data acquired from the subjects will only be linkable by the investigators.'