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

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Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)

This study is ongoing, but not recruiting participants.
Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
Official Title ^†	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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure ^†	Sustained reduction in ALT to either 50% of baseline value or < 40 U/L [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measure ^†	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 ]
Condition ^†	Fatty Liver
Intervention ^†	Drug: Metformin Dietary Supplement: Vitamin E Drug: Matching placebo
MEDLINE PMIDs
Links	National Institute of Diabetes and Digestive and Kidney Diseases

Recruitment Information Fields
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	180
Start Date ^†	August 2005
Completion Date	September 2009
Eligibility Criteria ^†	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 ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00063635
Organization ID	NASH - PEDIATRICS
Secondary IDs ^††
Study Sponsor ^†	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	December 2007
First Received Date ^†	July 1, 2003
Last Updated Date	December 14, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.