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 range18 Years

SexMALE

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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

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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