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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT00399932
First received: November 14, 2006
Last updated: September 17, 2009
Last verified: September 2009

November 14, 2006
September 17, 2009
March 2006
May 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00399932 on ClinicalTrials.gov Archive Site
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Non-invasive Evaluation of Hepatic Fibrosis in Patients With the Metabolic Syndrome
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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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

liver biopsy serum

Probability Sample

patients with type 2 diabetes

Metabolic Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
May 2010
May 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 75 Years
No
Contact: Yves J Horsmans, M.D.,Ph.D. 32 2 764 28 37 horsmans@gaen.ucl.ac.be
Contact: Bernard VanBeers, M.D. 32 2 764 29 45 vanbeers@rdgn.ucl.ac.be
Belgium
 
NCT00399932
ELASTO1
No
Prof Y Horsmans, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Not Provided
Study Director: Yves J Horsmans, M.D.,PhD StLuc university hospital, Université catholique de Louvain (UCL), Brussels, Belgium
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP