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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
History of Changes
  Purpose

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.


Condition Intervention
Liver Disease
 Procedure: Bariatric surgery
Procedure: cholecystectomy or benign liver tumor removal

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Non Alcoholic Metabolic Liver Diseases in Patients Harboring Central Adiposity and Insulin Resistance by Biochemical and Functional Genomic Approaches

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 90
Study Start Date: February 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
T
(n=30): without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor.
 Procedure: cholecystectomy or benign liver tumor removal
cholecystectomy or benign liver tumor removal
A
(n=30): with central adiposity, insulin resistance and hepatic steatosis (histology).
 Procedure: Bariatric surgery
Gastric bypass.
B
(n=30): with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology).
 Procedure: Bariatric surgery
Gastric bypass.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844779

Contacts
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

Locations
France
Service d'Hépato-Gastro-Entérologie - Nouvel Hôpital Civil Not yet recruiting
Strasbourg, France, 67091
Contact: Michel DOFFOEL, MD     (33) 3 69 55 04 82     michel.doffoel@chru-strasbourg.fr    
Sub-Investigator: François HABERSETZER, MD            
Principal Investigator: Michel DOFFOEL, MD            
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Michel VIX, MD     (33) 3 69 55 10 52     michel.vix@chru-strasbourg.fr    
Principal Investigator: Michel VIX, MD            
Sub-Investigator: Jacques MARESCAUX, MD            
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Michel DOFFOEL, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00844779     History of Changes
Other Study ID Numbers: 3966
Study First Received: February 13, 2009
Last Updated: April 24, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
Metabolic syndrome- hepatic steatosis- steatohepatitis - gene expression
Non alcoholic fatty liver disease (NFALD)

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 18, 2013