CompletedNot Applicable

Evaluation of Body Iron Stores in Overweight Healthy Volunteers

France14 participantsStarted 2011-07

Plain-language summary

Normal body iron store value in overweight subjects is currently not described in literature. The comparison of this value with body iron levels in patients suffering from dysmetabolic iron overload syndrome (DIOS) could allow to quantify iron overload in this condition. The purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to DIOS patients treated with phlebotomy.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male, * At least 18 years old * BMI \> 25 Kg/m2 * Serum ferritin level between 100 et 300 µg/L * Written informed consent Exclusion Criteria: * Blood donations in the past two years * Alcohol consumption more than 30 g/day * Inflammatory syndrome (CRP \> 10 mg/L) * Inflammatory, dysimmunitary or cancerous disease * Hepatic cytolysis * Transferrin saturation \> 45% * Person involved in another clinical trial * Person with a measure of legal protection (guardianship) * Person who reached the annual limit for compensation provided by biomedical research * Hemoglobin \< 13 g/dL * Uncontrolled heart failure or coronary insufficiency * Abnormal ECG * Echocardiographic abnormalities contraindicating phlebotomy * Hepatic, renal or respiratory insufficiency * Superficial venous network insufficiency

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Amount of mobilized iron (AMI) in grams collected by phlebotomies to have a ferritin level < 50 µg/L

Timeframe: Every 14 days, up to 3 months

Trial details

NCT IDNCT02304874

SponsorRennes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-06

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