Fatty Liver and Ectopic Fat in Overweight and Obese Patients
This study is currently recruiting participants.
Verified March 2010 by Centre Hospitalier Universitaire de Nice
Sponsor:
Centre Hospitalier Universitaire de Nice
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
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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
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 Cardiac Complexes, Premature Overweight Liver Diseases Digestive System Diseases Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013