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The purpose of this study is to evaluate the effect of iron depletion with phlebotomies on blood triglyceride concentration, in subjects with hypertriglyceridemia and iron overload, compared with a dietary intervention alone.
All subjects in this study will follow dietary and lifestyle counseling in a period of 3 months.
A randomized group will receive phlebotomies every 3 weeks in this period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phlebotomy associated with dietary and lifestyle counseling | Experimental |
| |
| Dietary and lifestyle counseling. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phlebotomy | Procedure | Volume of 400 mL every 3 weeks, 3 times. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Triglycerides concentration | Three months before |
| Measure | Description | Time Frame |
|---|---|---|
| Iron parameters | Ferritin level: >300 µgr/L in men and >200 µgr/L in women | Three months before |
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol | Three months before | |
| HDL-cholesterol | Three months before | |
| LDL- cholesterol |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Civeira, MD, PhD | Unidad de LÃpidos/ Laboratorio de Investigación Molecular; Hospital Universitario Miguel Servet; Instituto Aragonés de Ciencias de la Salud (Zaragoza, Spain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30049591 | Derived | Mateo-Gallego R, Lacalle L, Perez-Calahorra S, Marco-Benedi V, Recasens V, Padron N, Lamiquiz-Moneo I, Baila-Rueda L, Jarauta E, Calmarza P, Cenarro A, Civeira F. Efficacy of repeated phlebotomies in hypertriglyceridemia and iron overload: A prospective, randomized, controlled trial. J Clin Lipidol. 2018 Sep-Oct;12(5):1190-1198. doi: 10.1016/j.jacl.2018.06.017. Epub 2018 Jul 4. |
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| Dietary and lifestyle counseling. | Behavioral | Dietary and lifestyle counseling. |
|
| Three months before |
| Apolipoprotein A1 | Three months before |
| Apolipoprotein B | Three months before |
| Peripheral Insulin resistance measured by HOMA | Three months before |
| Inflammatory cytokines | Three months before |
| C Reactive Protein | Three months before |
| ID | Term |
|---|---|
| D000085583 | Hyperferritinemia |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| D004032 | Diet |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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