Non-invasive Evaluation of Hepatic Fibrosis in Patients With the Metabolic Syndrome

NCT ID: NCT00399932

Last Updated: 2009-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2010-05-31

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.

Conditions

Metabolic Syndrome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Principal Investigators

Yves J Horsmans, M.D.,PhD

Role: STUDY_DIRECTOR

StLuc university hospital, Université catholique de Louvain (UCL), Brussels, Belgium

Locations

StLuc University Hospital

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Yves J Horsmans, M.D.,Ph.D.

Role: CONTACT

horsmans@gaen.ucl.ac.be

32 2 764 28 37

Bernard VanBeers, M.D.

Role: CONTACT

vanbeers@rdgn.ucl.ac.be

32 2 764 29 45

Other Identifiers

ELASTO1

Identifier Type: -

Identifier Source: org_study_id