Cytochrome P450 2E1 and Iron Overload

Rennes University Hospital

Status and phase

Completed

Phase 2

Conditions

Iron Overload

Insulin Resistance

Treatments

Procedure: venesection

Study type

Interventional

Funder types

Other

Identifiers

NCT00138684

DGS 2003/0052

PHRC/02-09 (Other Identifier)

CIC0203/015

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)