Healthy Volunteers, Overweight
Conditions
Keywords
Ferritins, Iron Overload, Metabolic Syndrome, Venesection therapy, Volunteers
Brief 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.
Detailed description
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).
Interventions
OTHERPhlebotomy
Sponsors
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of mobilized iron (AMI) in grams collected by phlebotomies to have a ferritin level < 50 µg/L | Every 14 days, up to 3 months | 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. |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed