Evaluation of Body Iron Stores in Overweight Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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. DIOS is the leading cause of hyperferritinemia and mainly affects men between 45 and 60 years. It is characterized by unexplained hyperferritinemia associated to metabolic disorders (including overweight) and iron overload, objectified by MRI or liver biopsy. Some authors suggest that hyperferritinemia associated to metabolic disorders is the expression of an inflammatory syndrome caused by insulin resistance and steatohepatitis, and not the manifestation of real iron overload. The debate surrounding iron overload in DIOS is related to the limits of the current analysis methods (phlebotomy, liver iron concentration, MRI). At present, phlebotomy is the standard method used to determine body iron stores. Using this method, the purpose of the study is to determine iron levels in healthy overweight volunteers, and to compare them to DIOS patients treated with phlebotomy included in another ongoing clinical trial (SAIGNEES - ClinicalTrials.gov Identifier: NCT01045525).

Official Title
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Evaluation of Body Iron Stores in Overweight Healthy Volunteers

Conditions
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Healthy Volunteers, Overweight

Intervention / Treatment
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* Other: Phlebotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Phlebotomy<br>Phlebotomies will be performed every 14 days at the Clinical Investigation Unit (CIU) until the value of ferritin level is below 50 µg/mL and/or the value of hemoglobin level is below 12 g/dL. | Other: Phlebotomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of mobilized iron (AMI) in grams collected by phlebotomies to have a ferritin level < 50 µg/L | Phlebotomies will be performed every 14 days at the Clinical Investigation Unit, until ferritin level is below 50 µg/mL and/or hemoglobin is below 12 g/dL. | Every 14 days, up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum hepcidin level variation during the phlebotomy |  | Every 14 days, up to 3 months | 
| Serum soluble transferrin receptor variation during the phlebotomy |  | Every 14 days, up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ferritins, Iron Overload, Metabolic Syndrome, Venesection therapy, Volunteers