Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT00844779

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Observational

Anticipated 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 :

Feb 1, 2009

Anticipated Primary Completion Date :

Jan 1, 2011

Anticipated Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	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.

Arm

Intervention/Treatment

(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

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

Procedure: Bariatric surgery

Gastric bypass.

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

Procedure: Bariatric surgery

Gastric bypass.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Service d'Hépato-Gastro-Entérologie - Nouvel Hôpital Civil	Strasbourg		France	67091
2	Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil	Strasbourg		France	67091

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator: Michel DOFFOEL, MD, Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00844779

Other Study ID Numbers:

3966

First Posted:

Feb 16, 2009

Last Update Posted:

Apr 27, 2009

Last Verified:

Apr 1, 2009

Keywords provided by , ,

Metabolic syndrome- hepatic steatosis- steatohepatitis - gene expression

Non alcoholic fatty liver disease (NFALD)

Additional relevant MeSH terms:

Liver Diseases

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Apr 27, 2009