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

Metabolic Syndrome Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00399932
• Other study ID #: ELASTO1
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2006
• Last updated: September 17, 2009
• Start date: March 2006
• Est. completion date: May 2010

Study information

• Verified date: September 2009
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Yves J Horsmans, M.D.,Ph.D.
• Phone: 32 2 764 28 37
• Email: horsmans[@]gaen.ucl.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: May 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X

Locations

Country	Name	City	State
Belgium	StLuc University Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium,