TREATMENT OF NONALCOHOLIC LIVER DISEASE IN CHILDREN (TONIC)

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项多中心、蒙面、安慰剂对照、随机临床试验，旨在确定与安慰剂治疗相比，二甲双胍或维生素E治疗96周是否能导致非糖尿病NAFLD儿童血清ALT持续降低。在随机化之前可能有长达16周的筛选，96周的治疗阶段，然后是24周的治疗后随访阶段。共有180名患者被分为3组（每组60名：二甲双胍、维生素E、安慰剂），将从9个儿科医院入组。

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. This is a multicenter, masked, placebo-controlled, randomized clinical trial designed to determine whether 96 weeks of treatment with either metformin or vitamin E leads to sustained reduction in serum ALT in nondiabetic children with NAFLD compared to treatment with placebo. There can be up to 16 weeks of screening prior to randomization, a 96-week treatment phase, and then a 24-week post-treatment follow-up phase. A total of 180 patients in 3 groups of equal size (60 per group: metformin, vitamin E, placebo) will be enrolled from 9 pediatric sites.