Cytochrome P450 2E1 and Iron Overload

This study has been completed.

First Received: August 29, 2005 Last Updated: September 18, 2006 History of Changes

Sponsor:	Rennes University Hospital
Collaborator:	Ministry of Health, France
Information provided by:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00138684

Purpose

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.

Condition	Intervention
Insulin Resistance Iron Overload	Procedure: venesection therapy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Cytochrome P450 2E1 and Iron Overload

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:

chlorzoxazone metabolization rate before and after venesection

Estimated Enrollment:	50
Study Start Date:	September 2003
Estimated Study Completion Date:	December 2005

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138684

Locations

France
Unité d'Investigation Clinique - Hôpital Pontchaillou
Rennes, France, 35033

Sponsors and Collaborators

Rennes University Hospital

Ministry of Health, France

Investigators

Study Chair:	Jean-Michel Reymann, PhD	CHU Rennes
Principal Investigator:	Fabrice Lainé, MD	CHU Rennes

More Information

No publications provided

Study ID Numbers:	DGS 2003/0052, PHRC/02-09, CIC0203/015
Study First Received:	August 29, 2005
Last Updated:	September 18, 2006
ClinicalTrials.gov Identifier:	NCT00138684 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Rennes University Hospital:

insulin resistance
iron overload
phlebotomy
hepatic iron overload

Additional relevant MeSH terms:

Hyperinsulinism
Metabolic Diseases
Iron Metabolism Disorders

Iron Overload
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 22, 2009