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. Insulin resistance and oxidative stress (resulting in lipid peroxidation) are considered to be the two most important mechanisms in the pathogenesis of Non-Alcoholic Fatty Liver Disease (NAFLD. We hypothesize that metformin and vitamin E will lead to sustained reduction in serum ALT in biopsy proven NAFLD through changes in insulin resistance or oxidative stress. The principal objective of this randomized, multicenter, double-masked, placebo-controlled trial is to evaluate 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.
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