The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.

Condition	Treatment or Intervention	Phase
Fatty Liver	Drug: Metformin  Drug: Vitamin E  Drug: Placebo	Phase III

Ages Eligible for Study:  8 Years   -   15 Years,  Genders Eligible for Study:  Both

Criteria

• Age 8-15 years at first screening visit
• Histologic evidence of Nonalcoholic Fatty Liver Disease (NAFLD)
• ALT level >1.5 times the upper limit of normal within two weeks of randomization and within the prior 6 months
• Willingness to avoid pregnancy through abstinence or effective birth control methods
• Consent

California
      University of California, San Diego, San Diego,  California,  92103,  United States
      University of California, San Francisco, San Francisco,  California,  94143,  United States
Indiana
      Indiana University, Indianapolis,  Indiana,  46202,  United States
Maryland
      Johns Hopkins University, Baltimore,  Maryland,  21205,  United States
Missouri
      St. Louis University, St. Louis,  Missouri,  63110,  United States
Ohio
      Case Western Reserve University, Cleveland,  Ohio,  44109,  United States
Virginia
      Virginia Commonwealth University, Richmond,  Virginia,  23298,  United States
Washington
      University of Washington, Seattle,  Washington,  98195,  United States

Study ID Numbers:  NASH - PEDIATRICS
Record last reviewed:  January 2005
Last Updated:  January 4, 2005
Record first received:  July 1, 2003
ClinicalTrials.gov Identifier:  NCT00063635
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08