Iron OverloadNCT00378469
Study of the Effects of Muscular Activity on Iron Metabolism
A study testing 45 minute exercise on ergocycle in people with Iron Overload and Iron Deficiency, run by Rennes University Hospital at 2 sites in France.
Trial summary
The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will have to pedal on an ergocycle for 45 minutes, and urine and blood samples will be collected regularly to measure hemojuvelin, hepcidin, iron and transferrin levels. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Overload, Iron Deficiency
- What is being tested?
- 45 minute exercise on ergocycle
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 14 participants
- Where
- 2 sitesFrance
- Study dates
- Sep 2006to not given
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male individuals aged between 18 and 40 years old
- Body mass index (BMI) between 18 and 25
- Normal at clinical examination
- Normal biological variables
- Written informed consent
Who cannot join
- Mutation C282Y of the HFE gene
- Iron metabolism abnormality
- Inflammatory syndrome
- Chronic pathology or ongoing treatment
- Tobacco smoking, alcohol consuming more than 30g/day
- History of transfusion or blood-giving within 3 months
- Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Service des Maladies du Foie - Hôpital de Pontchaillou
Rennes, 35033
Pierre Brissot, MD, 33-2-9928-4297, pierre.brissot@univ-rennes1.fr
Pierre Brissot, MD
- Recruiting
Unité de Biologie et Médecine du Sport - Hôpital de Pontchaillou
Rennes, 35033
Pierre Rochcongar, MD, 33-2-9928-9323, pierre.rochcongar@chu-rennes.fr
Pierre Rochcongar, MD
About this study
Official title: Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers
The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will have to pedal on an ergocycle for 45 minutes, and urine and blood samples will be collected regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.
Read the detailed description
Hemojuvelin has been described as interfering with hepcidin, a key regulator of iron homeostasis. Hemojuvelin is mainly produced by muscle, and the relationship between exercise and iron metabolism can be questioned about.
The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will be investigated at two periods according to a cross-over design after:
- 45 minutes of exercise on the ergocycle; and
- no physical exercise.
Urine and blood samples will be collected at both periods regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.
- Conditions
- Iron Overload, Iron Deficiency
- Being tested
- 45 minute exercise on ergocycle
- Keywords
- Hepcidin, Hemojuvelin, Iron, Healthy volunteers
- Medical subject headings
- Iron Overload, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
45 minute exercise on ergocycleBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of urinary hepcidin
Pharmacokinetics of blood hemojuvelin
Secondary outcomes (1)
Pharmacokinetics of urine and blood iron, transferrin, interleukin-6 (IL-6) and ferritin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2006 (estimated)
- Study startSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron OverloadStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Pierre Brissot, MD, Principal investigator, Rennes University HospitalBruno Laviolle, MD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378469
- Sponsor's protocol ID
- DGS 2006/0415
- Other IDs
- LOC/05-07, CIC0203/061
- Status last verified
- May 2007
- First submitted
- 19 Sep 2006
- Last updated
- 12 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Muscular Activity on Iron Metabolism: A Pilot Study on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00378469
- Acronym / sponsor ID
- DGS 2006/0415
- Conditions
- Iron Overload, Iron Deficiency
- Keywords
- Hepcidin, Hemojuvelin, Iron, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Sep 2006
- First posted
- 20 Sep 2006 (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 this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will have to pedal on an ergocycle for 45 minutes, and urine and blood samples will be collected regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.
Detailed description
Hemojuvelin has been described as interfering with hepcidin, a key regulator of iron homeostasis. Hemojuvelin is mainly produced by muscle, and the relationship between exercise and iron metabolism can be questioned about.
The aim of this study is to evaluate the effect of muscular exercise on iron metabolism in healthy volunteers. Fourteen healthy male subjects will be investigated at two periods according to a cross-over design after:
- 45 minutes of exercise on the ergocycle; and
- no physical exercise.
Urine and blood samples will be collected at both periods regularly to measure hemojuvelin, hepcidin, iron and transferrin levels.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male individuals aged between 18 and 40 years old
- Body mass index (BMI) between 18 and 25
- Normal at clinical examination
- Normal biological variables
- Written informed consent
Key exclusion criteria (7 listed)
- Mutation C282Y of the HFE gene
- Iron metabolism abnormality
- Inflammatory syndrome
- Chronic pathology or ongoing treatment
- Tobacco smoking, alcohol consuming more than 30g/day
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 |
|---|---|---|
| 45 minute exercise on ergocycle | Behavioural | – |
Primary outcome
Pharmacokinetics of urinary hepcidin
Pharmacokinetics of blood hemojuvelin
1 secondary outcome
Pharmacokinetics of urine and blood iron, transferrin, interleukin-6 (IL-6) and ferritin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2007.
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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.
Pierre Brissot, MD principal investigator
Rennes University Hospital
Bruno Laviolle, MD study chair
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 study testing 45 minute exercise on ergocycle in people with Iron Overload and Iron Deficiency, 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Jul 2007. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Brissot, MD (33-2-9928-4297, pierre.brissot@univ-rennes1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of urinary hepcidin. The study lists 2 primary outcomes in all. 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 12 Jul 2007.