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

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00063635

Purpose

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	Intervention	Phase
Fatty Liver	Drug: Metformin Dietary Supplement: Vitamin E Drug: Matching placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Clinical Research Network in Nonalcoholic Steatohepatitis: Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases

Drug Information available for: alpha-Tocopheryl acetate alpha-Tocopherol Metformin Metformin hydrochloride Vitamin E Tocopherols Tocotrienol

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

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 Measures:

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 ]

Estimated Enrollment:	180
Study Start Date:	August 2005
Estimated Study Completion Date:	April 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Metformin, 500 mg, twice daily	Drug: Metformin 500 mg, twice daily
2: Active Comparator Vitamin E, 400 IU, twice daily	Dietary Supplement: Vitamin E 400 IU, twice daily
3: Placebo Comparator Matching placebo	Drug: Matching placebo Twice daily

Eligibility

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063635

Locations

United States, California
University of California, San Diego
San Diego, California, United States, 92103
University of California, San Francisco
San Francisco, California, United States, 94143
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Missouri
St. Louis University
St. Louis, Missouri, United States, 63110
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44109
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington
Seattle, Washington, United States, 98195

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More Information

Additional Information:

National Institute of Diabetes and Digestive and Kidney Diseases This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	NIDDK ( Patricia Robuck )
Study ID Numbers:	NASH - PEDIATRICS
Study First Received:	July 1, 2003
Last Updated:	November 23, 2009
ClinicalTrials.gov Identifier:	NCT00063635 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Non alcoholic fatty liver disease

Additional relevant MeSH terms:

Liver Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Metformin
Physiological Effects of Drugs
Fatty Liver

Protective Agents
Pharmacologic Actions
Vitamin E
Digestive System Diseases
Hypoglycemic Agents
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on November 25, 2009