The Nonalcoholic Steatohepatitis (NASH) Clinical Research Network is launching its first two clinical trials for the study of NASH, a liver disease that resembles alcoholic liver disease but occurs in patients who drink little or no alcohol. NASH occurs most often in adults over the age of 40 who are overweight or have diabetes, insulin resistance (pre-diabetes), or hyperlipidemia (excess concentrations of fatty materials in the blood). NASH can also occur in children, the elderly, normal-weight, and non-diabetic persons. The NASH Clinical Research Network and the clinical trial are funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), one of the National Institutes of Health (NIH).
NASH accounts for about 10 percent of newly diagnosed cases of chronic liver disease, and ranks as one of the leading causes of cirrhosis in the United States, following hepatitis C and alcoholic liver disease. Characteristics of the disease include abnormal liver enzyme levels, liver cell injury, inflammation and fibrosis in the liver, and excess amounts of fat stored in the liver. Though most people with NASH feel healthy and show no outward signs of a liver disease, NASH is progressive and can lead to cirrhosis and end-stage liver disease, which may require liver transplantation. The only way to distinguish NASH from other forms of fatty liver disease is with a liver biopsy.
"NASH has become a serious public health problem, because the incidence of NASH has risen with the increase of overweight and obesity in this country," says Patricia Robuck, Ph.D., M.P.H., project scientist for the NASH Clinical Research Network and director of the Clinical Trials Program within the Division of Digestive Diseases and Nutrition at the NIDDK.
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