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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00399932
Enrollment
75
Registered
2006-11-15
Start date
2006-03-31
Completion date
2010-05-31
Last updated
2009-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome, insulin resistance, NASH, hepatic fibrosis, Fibroscan, elastography by MRI

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.

Interventions

None listed

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

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

Countries

Belgium

Contacts

Primary ContactYves J Horsmans, M.D.,Ph.D.
horsmans@gaen.ucl.ac.be32 2 764 28 37
Backup ContactBernard VanBeers, M.D.
vanbeers@rdgn.ucl.ac.be32 2 764 29 45

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026