Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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:

Genetics Home Reference related topics: non-alcoholic fatty liver disease

MedlinePlus related topics: Fatty Liver Disease Liver Diseases

Genetic and Rare Diseases Information Center resources: Visceral Steatosis

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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

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

ClinicalTrials.gov processed this record on September 20, 2017

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