CClinicalTrials.gg
Status unknownNCT00844779Updated Apr 27, 2009

Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients

An observational study in Liver Disease, sponsored by University Hospital, Strasbourg, France. Status unknown at 2 sites in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2009-04-27.

Sponsored by University Hospital, Strasbourg, France · Observational

The sponsor has not verified this record recently (last verified Apr 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
18 Years to 60 Years
Sex
All
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Study summary

Non alcoholic fatty liver diseases (NAFLD) are represented by two main pathological conditions, hepatic steatosis (HS) and non alcoholic steatohepatitis (NASH), which are characterized by the accumulation of fat in the liver. The diagnosis of these two entities is achieved by histology and neither imaging nor biochemical markers are accurate enough to discriminate them. At the contrary of HS, NASH features hepatocyte necrosis, inflammation and fibrosis of variable intensity that could progress and ultimately evolve to cirrhosis. Therefore, it is important to distinguish between HS and NASH in order to treat the patients accordingly. In this study, the investigators aim to understand the molecular mechanisms that govern the transition from benign steatosis to complicated NASH. The investigators will analyze by "Q-RT-PCR" and "DNA microarray" technologies in the liver of obese patients, the expression of genes that are susceptible to be involved in the pathogenesis of NAFLD and identify the potential signaling pathways responsible for the progression of the disease.

02

Conditions studied

  • Liver Disease

Keywords

  • Metabolic syndrome- hepatic steatosis- steatohepatitis - gene expression
  • Non alcoholic fatty liver disease (NFALD)
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In context

Liver Diseases

2,080 studies on the registry are indexed under Liver Diseases; 389 are open to participants now.

This study's planned enrollment of 90 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 960 studies on the registry; 336 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic

Inclusion criteria

  • Group T(n=30): patient without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor
  • Group A (n=30): patient with central adiposity, insulin resistance and hepatic steatosis (histology).
  • Group B (n=30): patient with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology).

Exclusion criteria

Exclusion Criteria:

  • viral or autoimmune hepatitis
  • hematochromatosis
  • alcohol consumption (> 20 g/24h women, >30 g/24h men)
  • type 1 diabetes
  • inflammation or infection before procedure
  • abnormal hemostasis or coagulation- pregnancy
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • T

    (n=30): without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor.

    Procedure: cholecystectomy or benign liver tumor removal

  • A

    (n=30): with central adiposity, insulin resistance and hepatic steatosis (histology).

    Procedure: Bariatric surgery

  • B

    (n=30): with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology).

    Procedure: Bariatric surgery

Interventions

  • ProcedureBariatric surgery

    Gastric bypass.

  • Procedurecholecystectomy or benign liver tumor removal

    cholecystectomy or benign liver tumor removal

06

Study locations

1 of 2 sites recruiting
  • Service d'Hépato-Gastro-Entérologie - Nouvel Hôpital Civil
    Strasbourg, 67091, France
    • Michel DOFFOEL, MD · Contact · michel.doffoel@chru-strasbourg.fr · (33) 3 69 55 04 82
    • François HABERSETZER, MD · Sub investigator
    • Michel DOFFOEL, MD · Principal investigator
    Not yet recruiting
  • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
    Strasbourg, 67091, France
    • Michel VIX, MD · Contact · michel.vix@chru-strasbourg.fr · (33) 3 69 55 10 52
    • Michel VIX, MD · Principal investigator
    • Jacques MARESCAUX, MD · Sub investigator
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00844779
Lead sponsor
University Hospital, Strasbourg, France
First posted
Feb 16, 2009
Start date
Feb 2009
Primary completion
Jan 2011 (estimated)
Completion
Jan 2011 (estimated)
Last update
Apr 27, 2009

Study contacts

Ahmed Nassim DALI YOUCEF, PHD
Contact
ahmed.nassim.dali.youcef@chru-strasbourg.fr
(33) 3.69.55.11.84
Michel DOFFOEL, MD
Contact
michel.doffoel@chru-strasbourg.fr
(33) 3 69 55 04 82
Michel DOFFOEL, MD
principal investigator · Hôpitaux Universitaires de Strasbourg

Oversight

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

Not currently enrolling

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

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