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Cytochrome P450 2E1 and Iron Overload

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00138684
First received: August 29, 2005
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Insulin Resistance
Iron Overload
 Procedure: venesection
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cytochrome P450 2E1 and Iron Overload

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • variation of chlorzoxazone metabolization rate measured before and after venesection [ Time Frame: Baseline and after iron desaturation completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • variation of blood Malonedialdehyde rate [ Time Frame: Baseline and after iron desaturation completion ] [ Designated as safety issue: No ]
  • variation of blood 4-hydroxynonenal rate [ Time Frame: Baseline and after iron desaturation completion ] [ Designated as safety issue: No ]
  • variation of blood Glutathion rate [ Time Frame: Baseline and after iron desaturation completion ] [ Designated as safety issue: No ]
  • variation of serum Vitamin E rate [ Time Frame: Baseline and after iron desaturation completion ] [ Designated as safety issue: No ]
  • Variation of serum Vitamin C rate [ Time Frame: Baseline and after iron desaturation completion ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2003
Study Completion Date: February 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Venesection therapy Procedure: venesection
Venesection therapy is realised every 7 - 14 days until iron desaturation completion.
No Intervention: no venesection therapy

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00138684

Locations
France
CHU Nantes
Nantes, France
Unité d'Investigation Clinique - Hôpital Pontchaillou
Rennes, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Investigators
Study Chair: Jean-Michel Reymann, PhD CHU Rennes
Principal Investigator: Fabrice Lainé, MD CHU Rennes
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00138684     History of Changes
Other Study ID Numbers: DGS 2003/0052, PHRC/02-09, CIC0203/015
Study First Received: August 29, 2005
Last Updated: May 18, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Rennes University Hospital:
insulin resistance
iron overload
phlebotomy
hepatic iron overload

Additional relevant MeSH terms:
Insulin Resistance
Iron Overload
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Iron Metabolism Disorders
 Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013