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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phlebotomy | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phlebotomy | Other |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Laviolle, MD, PhD | Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou | Study Chair |
| Caroline Jezequel, MD | Centre d'Investigation Clinique Inserm 1414, Service de Pharmacologie Clinique, Hôpital de Pontchaillou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Pontchaillou | Rennes | 35000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26030828 | Result | Jezequel C, Laine F, Laviolle B, Kiani A, Bardou-Jacquet E, Deugnier Y. Both hepatic and body iron stores are increased in dysmetabolic iron overload syndrome. A case-control study. PLoS One. 2015 Jun 1;10(6):e0128530. doi: 10.1371/journal.pone.0128530. eCollection 2015. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D019190 | Iron Overload |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |