Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC) - Tabular View

Tracking Information
First Received Date ^ICMJE	July 1, 2003
Last Updated Date	December 14, 2007
Start Date ^ICMJE	August 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: December 14, 2007)	Sustained reduction in ALT to either 50% of baseline value or < 40 U/L [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 27, 2006)	Sustained reduction in ALT to either 50% of baseline value or < 40 U/L
Change History	Complete list of historical versions of study NCT00063635 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 14, 2007)	Sustained reduction in serum AST [ Time Frame: 96 weeks ] [ Designated as safety issue: No ] Sustained reduction in serum GGT [ Time Frame: 96 weeks ] [ Designated as safety issue: No ] Change in histologic feature scores determined by standardized scoring of liver biopsies at baseline and after 96 weeks of treatment [ Time Frame: 96 weeks ] [ Designated as safety issue: No ] Change in liver fibrosis, inflammation, or steatosis [ Time Frame: 96 weeks ] [ Designated as safety issue: No ] Change in body mass index [ Time Frame: 96 weeks ] [ Designated as safety issue: No ] Change in insulin resistance indices [ Time Frame: 96 weeks ] [ Designated as safety issue: No ] Change in serum vitamin E levels [ Time Frame: 96 weeks ] [ Designated as safety issue: No ] Change in serum lipid profile [ Time Frame: 96 weeks ] [ Designated as safety issue: No ] Change in QOL scores [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 27, 2006)	Sustained reduction in serum AST Sustained reduction in serum GGT Change in histologic feature scores determined by standardized scoring of liver biopsies at baseline and after 96 weeks of treatment Change in liver fibrosis, inflammation, or steatosis Change in body mass index Change in insulin resistance indices Change in serum vitamin E levels Change in serum lipid profile Change in QOL scores

Descriptive Information
Brief Title ^ICMJE	Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
Official Title ^ICMJE	Clinical Research Network in Nonalcoholic Steatohepatitis: Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Fatty Liver
Intervention ^ICMJE	Drug: Metformin Dietary Supplement: Vitamin E Drug: Matching placebo
Study Arms / Comparison Groups	Active Comparator: Metformin, 500 mg, twice daily Active Comparator: Vitamin E, 400 IU, twice daily Placebo Comparator: Matching placebo
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	180
Estimated Completion Date	September 2009
Primary Completion Date
Eligibility Criteria ^ICMJE	Age 8-17 years at first screening visit Histologic evidence of Nonalcoholic Fatty Liver Disease (NAFLD) - biopsy cannot be older than 6 months as of randomization ALT level >60 U/L at time of screening and on one previous occasion determined at least one month but no greater than 6 months prior to screening ALT Consent
Gender	Both
Ages	8 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00063635
Responsible Party	Patricia Robuck, NIDDK
Study ID Numbers ^ICMJE	NASH - PEDIATRICS
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP