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NASH is a liver disease that resembles alcoholic liver disease but occurs in patients who drink little or no alcohol.
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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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The NASH Clinical Research Network, consisting of eight clinical
centers and a data coordinating center, was formed in September 2002
to conduct research on the natural history, pathogenesis, and
treatment of NASH. With the information collected from observational
studies and clinical trials on both adult and pediatric NASH
patients, the Clinical Research Network will create a database of
information to be used by researchers in the development of
therapies for NASH. The Network also plans to encourage
collaborations among clinical and basic researchers to generate
information and develop ancillary studies using the resources of the
database.
While there are currently no proven treatments for NASH, results
from small pilot trials suggest that certain diabetes drugs improve
liver enzyme levels and may slow or reverse the progression of NASH.
Other pilot studies indicate that patients with this liver disease
show improvement by following a regimen of balanced diet and
exercise and also respond favorably to treatment with antioxidants
such as vitamin E.
The first two clinical trials for the NASH Clinical Research Network
will focus on the use of insulin-sensitizing agents and vitamin E
for the treatment of NASH in adults and in children. The first
clinical trial, the Pioglitazone versus Vitamin E versus Placebo for
the Treatment of Nondiabetic Patients with Nonalcoholic
Steatohepatitis (PIVENS) trial is currently recruiting non-diabetic
patients and will enroll 240 adults over
2 years into one of three treatment groups. Men and women aged 18
years and older will be assigned to either the vitamin E group,
pioglitazone (an insulin-sensitizing agent) group, or placebo group.
Potential patient volunteers will receive a standard oral glucose
tolerance test after a 12-hour fast to rule out the presence of
diabetes. Volunteers will also undergo liver biopsies at the start
and the end of the trial.
"We believe that even in the absence of diabetes, drugs that improve
insulin resistance may improve NASH. The PIVENS trial will test the
possibility that both pioglitazone and vitamin E are effective
treatments for NASH," says Arun Sanyal, M.D., co-chair, NASH CRN and
principal investigator for the center at Virginia Commonwealth
University in Richmond.
The second clinical trial, the "Treatment of Nonalcoholic Fatty
Liver Disease (NAFLD) in Children" (TONIC) trial, will enroll 180
children with NAFLD to receive vitamin E, metformin (an
insulin-sensitizing agent), or placebo over 18 months. The TONIC
trial will begin recruitment in June 2005.
"Having a clear understanding of the pathogenesis of NASH and its
natural history in both adults and children should translate into
better treatments that slow or prevent NASH from progressing,
ultimately improving the quality of life of patients with this liver
disease," says Jay Hoofnagle, M.D., director, NIDDK Liver Disease
Research Branch.
The eight clinical centers of the NASH Clinical Research Network
recruiting patients 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 data.
The NASH Clinical Research Network and the PIVENS and TONIC clinical
trials are funded by the NIDDK and an industry partner, Takeda
Pharmaceuticals. Additional funding is provided by the National
Institute of Child Health and Human Development, part of the NIH, an
agency of the U.S. Department of Health and Human Services.
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