Identification of Protective and Worsening Steatohepatitis (NASH) Factors
1 other identifier
interventional
150
1 country
1
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 steatohepatitis or steatosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 15, 2009
CompletedFirst Posted
Study publicly available on registry
June 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJune 5, 2009
June 1, 2009
1.7 years
April 15, 2009
June 4, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anatomopathologic study of the hepatic biopsies.
one day
Secondary Outcomes (5)
Seek protective and worsening factors by "microarray"
one day
Quantitative analyses of genes of interest in the liver and and visceral adipose tissue
one day
Immunohistochemical analyses
one day
Biochemical analyses
one day
Serum dosage of protein of interest
one day
Study Arms (3)
morbid obese subject
OTHERoverweight and NASH subjects
OTHERcontrol subjects
OTHERInterventions
hepatic biopsies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nice Hôpital de l'Archet
Nice, NICE, 06003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ALBERT TRAN, Ph D
Centre Hospitalier Universitaire de Nice
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 15, 2009
First Posted
June 5, 2009
Study Start
April 1, 2008
Primary Completion
December 1, 2009
Study Completion
April 1, 2010
Last Updated
June 5, 2009
Record last verified: 2009-06