Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients

NCT ID: NCT00844779

Last Updated: 2009-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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T

(n=30): without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor.

cholecystectomy or benign liver tumor removal

Intervention Type PROCEDURE

cholecystectomy or benign liver tumor removal

A

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

Bariatric surgery

Intervention Type PROCEDURE

Gastric bypass.

B

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

Bariatric surgery

Intervention Type PROCEDURE

Gastric bypass.

Interventions

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Bariatric surgery

Gastric bypass.

Intervention Type PROCEDURE

cholecystectomy or benign liver tumor removal

cholecystectomy or benign liver tumor removal

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg

Principal Investigators

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Michel DOFFOEL, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

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Service d'Hépato-Gastro-Entérologie - Nouvel Hôpital Civil

Strasbourg, , France

Site Status NOT_YET_RECRUITING

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Ahmed Nassim DALI YOUCEF, PHD

Role: CONTACT

(33) 3.69.55.11.84

Michel DOFFOEL, MD

Role: CONTACT

(33) 3 69 55 04 82

Facility Contacts

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Michel DOFFOEL, MD

Role: primary

(33) 3 69 55 04 82

Michel VIX, MD

Role: primary

(33) 3 69 55 10 52

Other Identifiers

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3966

Identifier Type: -

Identifier Source: org_study_id

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