The aim of the study is to determine, in patients presenting with insulin resistance and hepatic iron overload, the effects of venesection therapy on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection...
Date First Received: August 29, 2005
Last Updated: September 18, 2006
Verified by: Rennes University Hospital, September 2006
Clinical Trial Phase: N/A | Start Date: September 2003
Overall Status: Completed
Estimated Enrollment: 50
Brief Summary
Official Title: “Cytochrome P450 2E1 and Iron Overload”
Condition Keyword(s):
Intervention(s):
The aim of the study is to determine, in patients presenting with insulin resistance and hepatic iron overload, the effects of venesection therapy on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment
Intervention(s) in this Clinical Trial
- Procedure: venesection therapy
Outcome Measures for this Clinical Trial
Primary Measures
- chlorzoxazone metabolization rate before and after venesection
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Male patients aged from 18 to 70 years
- Hepatic iron overload measured by magnetic resonance imaging [MRI] (> 36 µmol/g)
- Related to insulin resistance
Exclusion Criteria:
- Excess alcohol consumption
- Female gender
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Rennes University Hospital
Overall Clinical Trial Officials and Contacts
Jean-Michel Reymann, PhD Study Chair CHU Rennes
Additional Information
Information obtained from ClinicalTrials.gov on October 07, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00138684
Study ID Number: DGS 2003/0052
ClinicalTrials.gov Identifier: NCT00138684
Health Authority: France: Afssaps - French Health Products Safety Agency
Clinical Trials Authorship and Review
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