Cytochrome P450 2E1 and Iron Overload

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2006-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Insulin Resistance Iron Overload

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Venesection therapy

Group Type EXPERIMENTAL

venesection

Intervention Type PROCEDURE

Venesection therapy is realised every 7 - 14 days until iron desaturation completion.

no venesection therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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venesection

Venesection therapy is realised every 7 - 14 days until iron desaturation completion.

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No