Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by University Hospital, Strasbourg, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00844779
First received: February 13, 2009
Last updated: April 24, 2009
Last verified: April 2009

February 13, 2009
April 24, 2009
February 2009
January 2011   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00844779 on ClinicalTrials.gov Archive Site
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Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients
Evaluation of Non Alcoholic Metabolic Liver Diseases in Patients Harboring Central Adiposity and Insulin Resistance by Biochemical and Functional Genomic Approaches

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum

Non-Probability Sample

Primary care clinic

Liver Disease
  • Procedure: Bariatric surgery
    Gastric bypass.
  • Procedure: cholecystectomy or benign liver tumor removal
    cholecystectomy or benign liver tumor removal
  • T
    (n=30): without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor.
    Intervention: Procedure: cholecystectomy or benign liver tumor removal
  • A
    (n=30): with central adiposity, insulin resistance and hepatic steatosis (histology).
    Intervention: Procedure: Bariatric surgery
  • B
    (n=30): with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology).
    Intervention: Procedure: Bariatric surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
January 2011
January 2011   (final data collection date for primary outcome measure)

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:

  • 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
Both
18 Years to 60 Years
No
Contact: Ahmed Nassim DALI YOUCEF, PHD (33) 3.69.55.11.84 ahmed.nassim.dali.youcef@chru-strasbourg.fr
Contact: Michel DOFFOEL, MD (33) 3 69 55 04 82 michel.doffoel@chru-strasbourg.fr
France
 
NCT00844779
3966
No
Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Michel DOFFOEL, MD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
April 2009

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