Status:
COMPLETED
Cytochrome P450 2E1 and Iron Overload
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Insulin Resistance
Iron Overload
Eligibility:
MALE
18-70 years
Phase:
PHASE2
Brief Summary
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 P...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00138684
Start Date
September 1 2003
End Date
February 1 2006
Last Update
May 21 2012
Active Locations (2)
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1
CHU Nantes
Nantes, France
2
Unité d'Investigation Clinique - Hôpital Pontchaillou
Rennes, France, 35033