TREATMENT OF NON-ALCOHOLIC FATTY LIVER DISEASE IN CHILDREN

这个子项目是许多研究子项目中的一个 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来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 TONIC的总结 儿童非酒精性脂肪肝的治疗（TONIC）是由NIDDK和NICHD赞助的一项研究。本研究的目的是确定与安慰剂治疗相比，二甲双胍或维生素E治疗96周是否会导致非糖尿病非酒精性脂肪肝儿童血清ALT持续降低。 这是一项III期随机、多中心、设盲、安慰剂对照临床试验。 有3个治疗组- 第1组-二甲双胍，500 mg PO b.i.d.和维生素E安慰剂b.i.d. 第2组-维生素E，400 IU天然形式PO，每日两次和二甲双胍安慰剂b.i.d. 第3组-美托洛尔安慰剂b.i.d.和维生素E -安慰剂b.i.d. 人口- 首次筛查访视时8-17岁的NAFLD儿童。 研究持续时间-每例患者 - 随机化前长达16周（112天）的筛选，包括随机化前使用抗NAFLD或降糖药物的患者至少3个月的药物洗脱期 - 96周治疗 - 治疗后24周随访 研究持续时间-每个日历时间 - 征聘阶段：2005年8月至2006年12月 - 后续阶段：2005年8月至2009年2月 临床中心数量- 8

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. Summary of TONIC Treatment of Non-Alcoholic Fatty Liver Disease in Children (TONIC) is a study sponsored by NIDDK and NICHD. The objective of this study is to determine whether 96 weeks of treatment with either metformin or vitamin E leads to a sustained reduction in serum ALT in non-diabetic children with Non-Alcoholic Fatty Liver Disease compared to treatment with placebo. It is a phase III randomized, multicenter, masked, placebo controlled clinical trial. There are 3 treatment groups- Group 1 - Metformin, 500mg PO b.i.d. and vitamin E placebo b.i.d. Group 2 - Vitamin E, 400 IU natural form PO bi.d. and metformin placebo b.i.d. Group 3 - Metformin placebo b.i.d. and Vitamin E - placebo b.i.d. Population - Children with NAFLD aged 8-17 years at first screening visit. Study duration - per patient - Up to 16 weeks (112 days) of screening prior to randomization, including at least 3 months of drug washout for those using antiNAFLD or antidiabetic medications prior to randomization - 96 week treatment - 24 week post treatment follow up Study duration - per calendar time - Recruitment phase: August 2005 - December 2006 - Follow up phase: August 2005 - February 2009 Number of clinical centers - 8