search
Back to results

Cytochrome P450 2E1 and Iron Overload

Primary Purpose

Insulin Resistance, Iron Overload

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
venesection
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring insulin resistance, iron overload, phlebotomy, hepatic iron overload

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU Nantes
  • Unité d'Investigation Clinique - Hôpital Pontchaillou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Venesection therapy

no venesection therapy

Arm Description

Outcomes

Primary Outcome Measures

variation of chlorzoxazone metabolization rate measured before and after venesection

Secondary Outcome Measures

variation of blood Malonedialdehyde rate
variation of blood 4-hydroxynonenal rate
variation of blood Glutathion rate
variation of serum Vitamin E rate
Variation of serum Vitamin C rate

Full Information

First Posted
August 29, 2005
Last Updated
May 18, 2012
Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
search

1. Study Identification

Unique Protocol Identification Number
NCT00138684
Brief Title
Cytochrome P450 2E1 and Iron Overload
Official Title
Cytochrome P450 2E1 and Iron Overload
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 P450 2E1 activity by comparing the rates of metabolization of chlorzoxazone before and after venesection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Iron Overload
Keywords
insulin resistance, iron overload, phlebotomy, hepatic iron overload

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Venesection therapy
Arm Type
Experimental
Arm Title
no venesection therapy
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
venesection
Intervention Description
Venesection therapy is realised every 7 - 14 days until iron desaturation completion.
Primary Outcome Measure Information:
Title
variation of chlorzoxazone metabolization rate measured before and after venesection
Time Frame
Baseline and after iron desaturation completion
Secondary Outcome Measure Information:
Title
variation of blood Malonedialdehyde rate
Time Frame
Baseline and after iron desaturation completion
Title
variation of blood 4-hydroxynonenal rate
Time Frame
Baseline and after iron desaturation completion
Title
variation of blood Glutathion rate
Time Frame
Baseline and after iron desaturation completion
Title
variation of serum Vitamin E rate
Time Frame
Baseline and after iron desaturation completion
Title
Variation of serum Vitamin C rate
Time Frame
Baseline and after iron desaturation completion

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel Reymann, PhD
Organizational Affiliation
CHU Rennes
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fabrice Lainé, MD
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nantes
City
Nantes
Country
France
Facility Name
Unité d'Investigation Clinique - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Learn more about this trial

Cytochrome P450 2E1 and Iron Overload

We'll reach out to this number within 24 hrs