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Cytochrome P450 2E1 and Iron Overload

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00138684
First Posted: August 30, 2005
Last Update Posted: May 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by:
Rennes University Hospital
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Cytochrome P450 2E1 and Iron Overload

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • variation of blood Malonedialdehyde rate [ Time Frame: Baseline and after iron desaturation completion ]
  • variation of blood 4-hydroxynonenal rate [ Time Frame: Baseline and after iron desaturation completion ]
  • variation of blood Glutathion rate [ Time Frame: Baseline and after iron desaturation completion ]
  • variation of serum Vitamin E rate [ Time Frame: Baseline and after iron desaturation completion ]
  • Variation of serum Vitamin C rate [ Time Frame: Baseline and after iron desaturation completion ]

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00138684     History of Changes
Other Study ID Numbers: DGS 2003/0052
PHRC/02-09 ( Other Identifier: Rennes University Hospital )
CIC0203/015
First Submitted: August 29, 2005
First Posted: August 30, 2005
Last Update Posted: May 21, 2012
Last Verified: May 2012

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