Status:
UNKNOWN
Identification of Protective and Worsening Steatohepatitis (NASH) Factors
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Morbid Obesity
Steatohepatitis
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The main aim of this work will be to identify a profile of gene expression by microarray in the liver which might allow to differentiate obese subjects having a normal liver from those with steatohepa...
Detailed Description
Recent epidemiological studies in France showed a strong prevalence of obesity (12,4%) and its strong increase during the 20 last years. Among the multiple complications related to obesity, the hepati...
Eligibility Criteria
Inclusion
- Inclusion Criteria for morbid obese subjects without diabetes:
- 18-60 years old, male or female
- Body mass index \> 40 kg/m2
- Obesity surgery required
- Alcohol consumption \< 20g per day
- Affiliation to national French health insurance
- Consent agreement
- Exclusion criteria:
- Hepatitis B, C, HIV
- Pregnant or breast-feeding woman.
- Inability to sign informed consent
- Patient with regulatory authority patient gold private freedom
- Hémochromatosis
- Toxic Hepatitis
- Alpha-1-anti-trypsin Deficiency
- Wilson disease
- Auto-immune hepatitis
- Drug Hepatitis
- Orlistat
- Inclusion criteria for controls subjects:
- Subjects of the 2 sexes of 18-60 years old
- Patients with normal body mass index between 20-25 kg/m2
- Patients profiting from hepatectomy for benign tumors like adenoma or bulky tumor hepatic biliary cyst or from a repair of the abdominal wall
- Subjects affiliated to a mode of social security
- Patient having signed the enlightened consent
- The private subjects from freedom and the major subjects under supervision will be excluded
- Inclusion criteria for overweight and NASH subjects:
- Subjects of the 2 sexes of 18-60 years old
- Patients with body mass index \> 25 kg/m2
- Alcohol Consumption \< 20 g/j
- Patient having a NASH in the hepatic biopsy
- Subjects affiliated to a mode of social security
- Patient having signed the enlightened consent
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00914446
Start Date
April 1 2008
End Date
April 1 2010
Last Update
June 5 2009
Active Locations (1)
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1
CHU de Nice Hôpital de l'Archet
Nice, NICE, France, 06003