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.

Study Overview

• Status: Unknown
• Conditions: Liver Disease
• Intervention / Treatment: Procedure: cholecystectomy or benign liver tumor removal; Procedure: Bariatric surgery

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Ahmed Nassim DALI YOUCEF, PHD; Phone Number: (33) 3.69.55.11.84; Email: ahmed.nassim.dali.youcef@chru-strasbourg.fr
• Study Contact Backup: Name: Michel DOFFOEL, MD; Phone Number: (33) 3 69 55 04 82; Email: michel.doffoel@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
    • Contact: Michel VIX, MD; Phone Number: (33) 3 69 55 10 52; Email: michel.vix@chru-strasbourg.fr
    • Sub-Investigator: Jacques Marescaux, MD
  • Strasbourg, France, 67091
    • Not yet recruiting
    • Service d'Hépato-Gastro-Entérologie - Nouvel Hôpital Civil
    • Contact: Michel DOFFOEL, MD; Phone Number: (33) 3 69 55 04 82; Email: michel.doffoel@chru-strasbourg.fr
    • Sub-Investigator: François HABERSETZER, MD
    • Principal Investigator: Michel DOFFOEL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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.

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Michel DOFFOEL, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: February 13, 2009
• First Submitted That Met QC Criteria: February 13, 2009
• First Posted (Estimate): February 16, 2009

Study Record Updates

• Last Update Posted (Estimate): April 27, 2009
• Last Update Submitted That Met QC Criteria: April 24, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: Metabolic syndrome- hepatic steatosis- steatohepatitis - gene expression; Non alcoholic fatty liver disease (NFALD)
• Additional Relevant MeSH Terms: Digestive System Diseases; Fatty Liver; Liver Diseases; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 3966

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No