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
Recruitment status was Recruiting
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 20, 2009 | ||||||||
| Last Updated Date | March 29, 2010 | ||||||||
| Start Date ICMJE | March 2010 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00886301 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Fatty Liver and Ectopic Fat in Overweight and Obese Patients | ||||||||
| Official Title ICMJE | Fatty Liver and Ectopic Fat in Overweight and Obese Patients | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Steatohepatitis | ||||||||
| Intervention ICMJE | Procedure: liver biopsy
liver biopsy |
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| Study Arm (s) | 1
obese or overweight patients with fatty liver or ectopic fat
Intervention: Procedure: liver biopsy |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00886301 | ||||||||
| Other Study ID Numbers ICMJE | 08-PP-08 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Centre Hospitalier Universitaire de Nice, Département de la Recherche Clinique et de l'Innovation | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Nice | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Nice | ||||||||
| Verification Date | March 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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