The Nonalcoholic Steatohepatitis (NASH) Clinical Research Network has launched its second clinical trial to study NASH, a liver disease that resembles alcoholic liver disease but occurs in patients who drink little or no alcohol. The first trial, launched in January of this year, focuses on adults, while the second trial studies the disease in children. The NASH Clinical Research Network and its clinical trials are funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), one of the National Institutes of Health (NIH).
The Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Children (TONIC) trial will enroll 180 boys and girls, ages 8-15 years with NAFLD. The participants will receive vitamin E, or metformin (an insulin-sensitizing drug), or placebo over 2 years. There are no weight cut-offs or percentiles for the children participating in TONIC. However, more than ninety percent of the children are expected to be obese. Volunteers need a baseline biopsy that demonstrates NAFLD to be eligible for the study. Children with diabetes and other chronic liver diseases will be excluded from TONIC.
While similar to alcoholic liver disease, NAFLD, occurs in persons who drink little to no alcohol. NAFLD is associated with overweight and obesity and occurs in a high proportion of persons with diabetes. But, it can also occur in adults and children who are normal weight without diabetes. Although there seems to be an association between obesity and liver injury, current research does not support a causal link or trigger from obesity to liver injury. TONIC investigators hope to uncover the underlying conditions that contribute to the development and progression of NAFLD in children.
The eight clinical centers of the NASH Clinical Research Network recruiting patients for both the TONIC and PIVENS trials include: Case Western Reserve University in Cleveland; Duke University Medical Center in Raleigh-Durham (adult site)/ Johns Hopkins University in Baltimore (pediatric site); Indiana University in Indianapolis; St. Louis University in Missouri; University of California in San Diego; University of California in San Francisco; University of Washington in Seattle; and Virginia Commonwealth University in Richmond. The Johns Hopkins University Bloomberg School of Public Health in Baltimore provides coordination of the research network studies.
Contact information for the centers is available at http://www.nashcrn.com.
For general information about NASH, visit http://digestive.niddk.nih.gov/ddiseases/pubs/nash/.
Message posted by: Rashmi Nemade