Fatty Liver and Ectopic Fat in Overweight and Obese Patients

Not Applicable

Completed

• Conditions: Steatohepatitis

• Registration Number: NCT00886301
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Study Start: 2010-03
• Primary Completion: 2014-10-02
• Study Completion: 2014-10-02
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients.	at year 1

Trial Locations

Locations (1)

Hepatogastroenterology, Hôpital l'Archet, CHU de Nice; 🇫🇷 Nice, France