Metabolic Syndrome Clinical Trial
Non-alcoholic fatty liver disease (NAFLD) is now recognised as the hepatic complication of
the metabolic syndrome of insulin resistance. In some patients, the disease can progress
into steatohepatitis (NASH) which associates fatty liver, hepatocellular damage, chronic
inflammation and variable and progressive fibrosis. The latter can evolve into cirrhosis and
end-stage liver disease.
Thus the presence of fibrosis sign the severity of the disease, and therefore its accurate
detection is crucial for the identification of patients in need of treatment and appropriate
follow-up.
To date, histological examination of a biopsy of the liver is the gold standard in the
diagnosis of fibrosis. the procedure is however associated with significant complication in
0.01 to 0.1% of cases and with sampling errors because it analyses only a minimal portion fo
the liver.
The aim of the study is to evaluate, in a population of patients with the metabolic
syndrome, whether non-invasive tests may identify those with hepatic fibrosis.
At inclusion, serum tests, fibroscan (elastography of the liver by ultra-sounds) and
elastography by MRI will be performed. Those tests will be repeated within 2 months.
A liver biopsy will be performed if 2 out of the 3 (serum test, fibroscan or elastography)
tests are suggestive of hepatic fibrosis.
This study will allow to determine
- whether hepatic fibrosis may be detected by non-invasive means in patients with
NAFLD/NASH.
- whether there is a correlation between non-invase tests and liver biopsy for assessment
of fibrosis and it severity
- whether the presence of fatty liver interfere with the results of the fibroscan and the
elastography.
- whether there are metabolic factors associated with an increased risk of fibrosis in
this population.
n/a
Observational Model: Case-Only, Time Perspective: Prospective
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