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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease
Metabolic Syndrome

Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : March 2006
Actual Primary Completion Date : May 2009
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Biospecimen Retention:   Samples Without DNA
liver biopsy serum

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with type 2 diabetes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00399932

Contact: Yves J Horsmans, M.D.,Ph.D. 32 2 764 28 37
Contact: Bernard VanBeers, M.D. 32 2 764 29 45

StLuc University Hospital Recruiting
Brussels, Belgium, 1200
Principal Investigator: Michel Hermans, M.D., Ph.D         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Director: Yves J Horsmans, M.D.,PhD StLuc university hospital, Université catholique de Louvain (UCL), Brussels, Belgium

Responsible Party: Prof Y Horsmans, Cliniques universitaires Saint-Luc- Université Catholique de Louvain Identifier: NCT00399932     History of Changes
Other Study ID Numbers: ELASTO1
First Posted: November 15, 2006    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
metabolic syndrome
insulin resistance
hepatic fibrosis
elastography by MRI

Additional relevant MeSH terms:
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases