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Fatty Liver and Ectopic Fat in Overweight and Obese Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886301
First Posted: April 22, 2009
Last Update Posted: March 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre Hospitalier Universitaire de Nice
  Purpose
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.

Condition Intervention
Steatohepatitis Procedure: liver biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fatty Liver and Ectopic Fat in Overweight and Obese Patients

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

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. [ Time Frame: at inclusion and at year 1 ]

Secondary Outcome Measures:
  • Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients. [ Time Frame: at year 1 ]

Estimated Enrollment: 100
Study Start Date: March 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
obese or overweight patients with fatty liver or ectopic fat
Procedure: liver biopsy
liver biopsy

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886301


Contacts
Contact: Rodolphe ANTY, Dr anty.r@chu-nice.fr
Contact: Annie FAFIN 04592035943 fafin.a@chu-nice.fr

Locations
France
Hepatogastroenterology, Hôpital l'Archet, CHU de Nice Recruiting
Nice, France, 06000
Principal Investigator: Rodolphe ANTY, Dr         
Sub-Investigator: Albert TRAN, PU PH         
Sub-Investigator: Jean-Louis SADOUL, PU PH         
Sub-Investigator: Patrick CHEVALLIER, PU PH         
Sub-Investigator: Sebastien NOVELLAS, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Rodolphe ANTY, Dr Hepatogastroentérology, CHU de Nice
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nice, Département de la Recherche Clinique et de l'Innovation
ClinicalTrials.gov Identifier: NCT00886301     History of Changes
Other Study ID Numbers: 08-PP-08
First Submitted: April 20, 2009
First Posted: April 22, 2009
Last Update Posted: March 30, 2010
Last Verified: March 2010

Keywords provided by Centre Hospitalier Universitaire de Nice:
overweight
obesity
steatohepatitis
ectopic fat

Additional relevant MeSH terms:
Overweight
Fatty Liver
Cardiac Complexes, Premature
Body Weight
Signs and Symptoms
Liver Diseases
Digestive System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Extracts
Hematinics