Clinical trial NCT00399932: Non-invasive Evaluation of Hepatic Fibrosis in Patients With the Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
insulin resistance
NASH
hepatic fibrosis
Fibroscan
elastography by MRI
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2006-11-15
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with type 2 diabetes

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* metabolic syndrome with 3 out of 5 criteria (ATP III definition)

Exclusion Criteria:

* alcohol intake \> 20g/day (women), \> 30g/day (men)
* chronic liver disease of other cause: viral hepatitis (HBV, HCV), Wilson's disease, haemochromatosis, alpha1 anti-trypsin deficiency, drug-induced, ...
* decompensated cirrhosis (Child-Pugh 3)
* body weight \> 120 Kg

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: StLuc University Hospital
Study officials:
affiliation: StLuc university hospital, Université catholique de Louvain (UCL), Brussels, Belgium
name: Yves J Horsmans, M.D.,PhD
role: STUDY_DIRECTOR
References: