NCT00138684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

May 21, 2012

Status Verified

May 1, 2012

Enrollment Period

2.3 years

First QC Date

August 29, 2005

Last Update Submit

May 18, 2012

Conditions

Insulin ResistanceIron Overload

Keywords

insulin resistanceiron overloadphlebotomyhepatic iron overload

Outcome Measures

Primary Outcomes (1)

  • variation of chlorzoxazone metabolization rate measured before and after venesection

    Baseline and after iron desaturation completion

Secondary Outcomes (5)

  • variation of blood Malonedialdehyde rate

    Baseline and after iron desaturation completion

  • variation of blood 4-hydroxynonenal rate

    Baseline and after iron desaturation completion

  • variation of blood Glutathion rate

    Baseline and after iron desaturation completion

  • variation of serum Vitamin E rate

    Baseline and after iron desaturation completion

  • Variation of serum Vitamin C rate

    Baseline and after iron desaturation completion

Study Arms (2)

Venesection therapy

EXPERIMENTAL
Procedure: venesection

no venesection therapy

NO INTERVENTION

Interventions

venesectionPROCEDURE

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

Venesection therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Nantes

Nantes, France

Location

Unité d'Investigation Clinique - Hôpital Pontchaillou

Rennes, 35033, France

Location

MeSH Terms

Conditions

Insulin ResistanceIron Overload

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesIron Metabolism Disorders

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean-Michel Reymann, PhD

    CHU Rennes

    STUDY CHAIR

  • Fabrice Lainé, MD

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

September 1, 2003

Primary Completion

December 1, 2005

Study Completion

February 1, 2006

Last Updated

May 21, 2012

Record last verified: 2012-05

Locations

FR(2)