Fatty Liver and Ectopic Fat in Overweight and Obese Patients

NCT ID: NCT00886301

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2014-10-02

Brief Summary

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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

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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.

Conditions

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Steatohepatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

obese or overweight patients with fatty liver or ectopic fat

Group Type OTHER

liver biopsy

Intervention Type PROCEDURE

liver biopsy

Interventions

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liver biopsy

liver biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rodolphe ANTY, Dr

Role: PRINCIPAL_INVESTIGATOR

Hepatogastroentérology, CHU de Nice

Locations

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Hepatogastroenterology, Hôpital l'Archet, CHU de Nice

Nice, , France

Site Status

Countries

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France

Other Identifiers

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08-PP-08

Identifier Type: -

Identifier Source: org_study_id

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