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Completed

NCT Number: NCT00138684

Cytochrome P450 2E1 and Iron Overload

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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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Iron Metabolism Disorders Iron Overload Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

CHU Nantes, Nantes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Venesection

Procedure

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

Primary outcomes

  1. variation of chlorzoxazone metabolization rate measured before and after venesection

    Time frame: Baseline and after iron desaturation completion

Secondary outcomes

  1. variation of blood Malonedialdehyde rate

    Time frame: Baseline and after iron desaturation completion

  2. variation of blood 4-hydroxynonenal rate

    Time frame: Baseline and after iron desaturation completion

  3. variation of blood Glutathion rate

    Time frame: Baseline and after iron desaturation completion

  4. variation of serum Vitamin E rate

    Time frame: Baseline and after iron desaturation completion

  5. Variation of serum Vitamin C rate

    Time frame: Baseline and after iron desaturation completion

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Ministry of Health, France

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2006
First posted
Aug 30, 2005
Registry last updated
May 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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