CClinicalTrials.gg
Status unknownNCT00399932Updated Sep 18, 2009

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

An observational study in Metabolic Syndrome, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Status unknown at 1 site in Belgium. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2009-09-18.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Observational

The sponsor has not verified this record recently (last verified Sep 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
75
Ages
30 Years to 75 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Metabolic Syndrome

Keywords

  • metabolic syndrome
  • insulin resistance
  • NASH
  • hepatic fibrosis
  • Fibroscan
  • elastography by MRI
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's planned enrollment of 75 is below the median of 200 across 458 observational studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
75 participants (estimated)
Biospecimen retention
Samples without dna
06

Study locations

1 of 1 sites recruiting
  • StLuc University Hospital
    Brussels, 1200, Belgium
    • Michel Hermans, M.D., Ph.D · Principal investigator
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00399932
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
First posted
Nov 15, 2006
Start date
Mar 2006
Primary completion
May 2009
Completion
May 2010 (estimated)
Last update
Sep 18, 2009

Study contacts

Yves J Horsmans, M.D.,Ph.D.
Contact
horsmans@gaen.ucl.ac.be
32 2 764 28 37
Bernard VanBeers, M.D.
Contact
vanbeers@rdgn.ucl.ac.be
32 2 764 29 45
Yves J Horsmans, M.D.,PhD
study director · StLuc university hospital, Université catholique de Louvain (UCL), Brussels, Belgium

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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