Cytochrome P450 2E1 and Iron Overload

May 18, 2012 updated by: Rennes University Hospital
The aim of the study is to determine, in patients presenting hepatic iron overload (genetic haemochtomatisis or dysmetabolic iron overload syndrome), the effects of venesection therapy on cytochrome P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male patients aged from 18 to 70 years
  • Hepatic iron overload measured by magnetic resonance imaging [MRI] (> 36 µmol/g and < 200 µmol/L)
  • Homozygosity for the C282Y mutation of the HFE or dysmetabolic iron overload syndrome (DIOS) based on the presence of at least one of these following metabolic abnormalities:
  • Overweight: BMI > 25 kg/m2
  • Waist/hip circumference (cm) > 0.90
  • Diabetes mellitus (fasting blood glucose level >1.25g/L or blood glucose level after 2 hours > 2g/L) or glucose intolerance (fasting blood glucose level between 1.10 and 1.25g/L)
  • Total cholesterolemia > 6.2 mmol/L or HDL-Cholesterol < 0.9 mmol/L
  • TG>= 1.7 mmol
  • Written informed consent

Non-Inclusion Criteria:

  • Consumption of alcohol > 50 g/day and of any CYP2E1 inhibitor substances
  • Smoker > 5 cigarets/day
  • History of blood donation or venesection
  • Other causes of iron overload: aceruloplasminaemia, haematological disorder (abnormal blood counting), late cutaneous porphyria (cutaneous bullous disorders and photosensibilisation) , martial treatment, repeated transfusions.
  • Inflammatory syndrome (CRP > 3ng/ml)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Venesection therapy
Procedure: venesection
Venesection therapy is realised every 7 - 14 days until iron desaturation completion.
NO_INTERVENTION: no venesection therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
variation of chlorzoxazone metabolization rate measured before and after venesection
Time Frame: Baseline and after iron desaturation completion
Baseline and after iron desaturation completion

Secondary Outcome Measures

Outcome Measure
Time Frame
variation of blood Malonedialdehyde rate
Time Frame: Baseline and after iron desaturation completion
Baseline and after iron desaturation completion
variation of blood 4-hydroxynonenal rate
Time Frame: Baseline and after iron desaturation completion
Baseline and after iron desaturation completion
variation of blood Glutathion rate
Time Frame: Baseline and after iron desaturation completion
Baseline and after iron desaturation completion
variation of serum Vitamin E rate
Time Frame: Baseline and after iron desaturation completion
Baseline and after iron desaturation completion
Variation of serum Vitamin C rate
Time Frame: Baseline and after iron desaturation completion
Baseline and after iron desaturation completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Fabrice Lainé, MD, Chu Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

February 1, 2006

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (ESTIMATE)

August 30, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 21, 2012

Last Update Submitted That Met QC Criteria

May 18, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DGS 2003/0052
  • PHRC/02-09 (OTHER: Rennes University Hospital)
  • CIC0203/015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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