Treatment of nonalcoholic fatty liver disease in children: TONIC trial design.

ABSTRACT:

Background

Nonalcoholic fatty liver disease (NAFLD) in children can lead to steatohepatitis, cirrhosis, and end-stage liver disease. The cause of NAFLD is unknown, but it is commonly associated with obesity, insulin resistance, and dyslipidemia.

Objectives

TONIC is conducted to test whether treatment with metformin, an insulin sensitizer, or vitamin E, a naturally available antioxidant, will lead to improvements in biochemical and histological features of nondiabetic children with biopsy-proven NAFLD.

Design

TONIC is a randomized, multicenter, double-masked, placebo-controlled trial of 96 weeks of treatment with metformin or vitamin E. The primary outcome measure chosen for the trial is improvement in serum alanine aminotransferase (ALT) levels with treatment as compa

SUBMITTER: Lavine JE 

PROVIDER: S-EPMC2936451 | biostudies-literature | 2010 Jan

REPOSITORIES: biostudies-literature