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Fatty Liver and Ectopic Fat in Overweight and Obese Patients

Primary Purpose

Steatohepatitis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
liver biopsy
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Steatohepatitis focused on measuring overweight, obesity, steatohepatitis, ectopic fat

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hepatogastroenterology, Hôpital l'Archet, CHU de NiceRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

obese or overweight patients with fatty liver or ectopic fat

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients.

Full Information

First Posted
April 20, 2009
Last Updated
March 29, 2010
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT00886301
Brief Title
Fatty Liver and Ectopic Fat in Overweight and Obese Patients
Official Title
Fatty Liver and Ectopic Fat in Overweight and Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Steatohepatitis
Keywords
overweight, obesity, steatohepatitis, ectopic fat

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
obese or overweight patients with fatty liver or ectopic fat
Intervention Type
Procedure
Intervention Name(s)
liver biopsy
Intervention Description
liver biopsy
Primary Outcome Measure Information:
Title
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.
Time Frame
at inclusion and at year 1
Secondary Outcome Measure Information:
Title
Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients.
Time Frame
at year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodolphe ANTY, Dr
Email
anty.r@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Annie FAFIN
Phone
04592035943
Email
fafin.a@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodolphe ANTY, Dr
Organizational Affiliation
Hepatogastroentérology, CHU de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hepatogastroenterology, Hôpital l'Archet, CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodolphe ANTY, Dr
First Name & Middle Initial & Last Name & Degree
Albert TRAN, PU PH
First Name & Middle Initial & Last Name & Degree
Jean-Louis SADOUL, PU PH
First Name & Middle Initial & Last Name & Degree
Patrick CHEVALLIER, PU PH
First Name & Middle Initial & Last Name & Degree
Sebastien NOVELLAS, Dr

12. IPD Sharing Statement

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Fatty Liver and Ectopic Fat in Overweight and Obese Patients

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