Insulin ResistancePhase 2NCT00138684
Cytochrome P450 2E1 and Iron Overload
A Phase 2 study testing venesection in people with Insulin Resistance and Iron Overload, run by Rennes University Hospital at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Insulin Resistance, Iron Overload
- What is being tested?
- venesection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2003to Feb 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Nantes
Nantes
Unité d'Investigation Clinique - Hôpital Pontchaillou
Rennes, 35033
About this study
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.
- Conditions
- Insulin Resistance, Iron Overload
- Being tested
- venesection
- Keywords
- insulin resistance, iron overload, phlebotomy, hepatic iron overload
- Medical subject headings
- Insulin Resistance, Iron Overload
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venesectionProcedure or surgery
Venesection therapy is realised every 7 - 14 days until iron desaturation completion.
| Study group | Role | What they receive |
|---|---|---|
| Venesection therapy | Experimental | Not described Receives: Procedure: venesection |
| no venesection therapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of chlorzoxazone metabolization rate measured before and after venesection
Measured: Baseline and after iron desaturation completion
Secondary outcomes (5)
variation of blood Malonedialdehyde rate
Measured: Baseline and after iron desaturation completion
variation of blood 4-hydroxynonenal rate
Measured: Baseline and after iron desaturation completion
variation of blood Glutathion rate
Measured: Baseline and after iron desaturation completion
variation of serum Vitamin E rate
Measured: Baseline and after iron desaturation completion
Variation of serum Vitamin C rate
Measured: Baseline and after iron desaturation completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startSep 2003
- Primary completionDec 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Investigators
- Jean-Michel Reymann, PhD, Study chair, Rennes University HospitalFabrice Lainé, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138684
- Sponsor's protocol ID
- DGS 2003/0052
- Other IDs
- PHRC/02-09, CIC0203/015
- Status last verified
- May 2012
- First submitted
- 29 Aug 2005
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytochrome P450 2E1 and Iron Overload
- ClinicalTrials.gov ID
- NCT00138684
- Acronym / sponsor ID
- DGS 2003/0052
- Conditions
- Insulin Resistance, Iron Overload
- Keywords
- insulin resistance, iron overload, phlebotomy, hepatic iron overload
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venesection therapy | Experimental | Procedure: venesection |
| no venesection therapy | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venesectionVenesection therapy is realised every 7 - 14 days until iron desaturation completion. | Procedure or surgery | Venesection therapy |
Primary outcome
variation of chlorzoxazone metabolization rate measured before and after venesection
Time frame: Baseline and after iron desaturation completion
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel Reymann, PhD study chair
Rennes University Hospital
Fabrice Lainé, MD principal investigator
Rennes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing venesection in people with Insulin Resistance and Iron Overload, run by Rennes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of chlorzoxazone metabolization rate measured before and after venesection (time frame: Baseline and after iron desaturation completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2012; AzTrials last refreshed its copy on 3 Nov 2026.