NCT00844779

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 27, 2009

Status Verified

April 1, 2009

Enrollment Period

1.9 years

First QC Date

February 13, 2009

Last Update Submit

April 24, 2009

Conditions

Liver Disease

Keywords

Metabolic syndrome- hepatic steatosis- steatohepatitis - gene expressionNon alcoholic fatty liver disease (NFALD)

Study Arms (3)

T

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

Procedure: cholecystectomy or benign liver tumor removal

A

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

Procedure: Bariatric surgery

B

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

Procedure: Bariatric surgery

Interventions

Bariatric surgeryPROCEDURE

Gastric bypass.

AB
cholecystectomy or benign liver tumor removalPROCEDURE

cholecystectomy or benign liver tumor removal

T

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Strasbourg, 67091, France

NOT YET RECRUITING

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67091, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Liver DiseasesNon-alcoholic Fatty Liver Disease

Interventions

Bariatric SurgeryCholecystectomy

Condition Hierarchy (Ancestors)

Digestive System DiseasesFatty Liver

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, OperativeBiliary Tract Surgical ProceduresDigestive System Surgical Procedures

Study Officials

  • Michel DOFFOEL, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Nassim DALI YOUCEF, PHD

CONTACT

(33) 3.69.55.11.84ahmed.nassim.dali.youcef@chru-strasbourg.fr

Michel DOFFOEL, MD

CONTACT

(33) 3 69 55 04 82michel.doffoel@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 16, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 27, 2009

Record last verified: 2009-04

Locations

FR(2)