Non-invasive Evaluation of Hepatic Fibrosis in Patients With the Metabolic Syndrome
|ClinicalTrials.gov Identifier: NCT00399932|
Recruitment Status : Unknown
Verified September 2009 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was: Recruiting
First Posted : November 15, 2006
Last Update Posted : September 18, 2009
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||May 2009|
|Estimated Study Completion Date :||May 2010|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399932
|Contact: Yves J Horsmans, M.D.,Ph.D.||32 2 764 28 firstname.lastname@example.org|
|Contact: Bernard VanBeers, M.D.||32 2 764 29 email@example.com|
|StLuc University Hospital||Recruiting|
|Brussels, Belgium, 1200|
|Principal Investigator: Michel Hermans, M.D., Ph.D|
|Study Director:||Yves J Horsmans, M.D.,PhD||StLuc university hospital, Université catholique de Louvain (UCL), Brussels, Belgium|