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Fatty Liver and Ectopic Fat in Overweight and Obese Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00886301
First received: April 20, 2009
Last updated: March 29, 2010
Last verified: March 2010
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients. [ Time Frame: at year 1 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 20, 2009
Last Updated: March 29, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: Institutional Ethical Committee
France: Ministry of Health

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

Additional relevant MeSH terms:
Fatty Liver
Overweight
Body Weight
Digestive System Diseases
Liver Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014