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NCT00886301 Clinical Trial

Fatty Liver and Ectopic Fat in Overweight and Obese Patients

Steatohepatitis Clinical Trial

Official title:
Fatty Liver and Ectopic Fat in Overweight and Obese Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00886301
Other study ID # 08-PP-08
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2010
Est. completion date October 2, 2014

Study information
Verified date November 2023
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

Description:

Non invasive assessment of liver fibrosis and liver inflammation and steatosis is clinically relevant in patients exposed to non alcoholic fatty liver diseases. The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients. Fatty liver and ectopic fat accumulation will be particularly assessed.

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date October 2, 2014
Est. primary completion date October 2, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - BMI between 25 and 40 - ALAT level superior to normal level even after 3 months of diet - alcohol consumption < 20 g/j for women and < 30 g/j for men Exclusion Criteria: - HIV, hepatitis B virus, hepatitis C virus positive - known hemochromatosis - glycemia > 1.26 g/L or under anti-diabetic treatment

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• liver biopsy
liver biopsy

Locations
Country Name City State
France Hepatogastroenterology, Hôpital l'Archet, CHU de Nice Nice

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Liver status will be will be determined by liver biopsy, non invasive liver assessment. Biological and medical imaging parameters will be use to characterize our patients. at inclusion and at year 1
Secondary Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients. at year 1
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