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Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients

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ClinicalTrials.gov Identifier: NCT00844779
Recruitment Status : Unknown
Verified April 2009 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : February 16, 2009
Last Update Posted : April 27, 2009
Sponsor:
Information provided by:
University Hospital, Strasbourg, France

Study Description
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Brief 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.

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

Study Design
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Study Type : Observational
Estimated Enrollment : 90 participants
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
Study Start Date : February 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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Biospecimen Retention:   Samples Without DNA
Serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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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
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: April 27, 2009
Last Verified: April 2009

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

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Insulin
 Liver Extracts
Hypoglycemic Agents
Physiological Effects of Drugs
Hematinics