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| Name | Class |
|---|---|
| SESCAM Centro Regional de Transfusión Toledo-Guadalajara. | UNKNOWN |
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Studies in the literature suggest that people with obesity have an excess of stored iron. There is possibly an inverse relationship between ferritin levels and the actions of insulin on glycemic control. The reduction of stored iron by simply donating blood could result in improvements in glycemic control in people with obesity and prediabetes. We propose, to reduce ferritin levels through a standard donation of a unit of whole blood, and to measure if it positively affects glycemic control.
Individuals with pre-diabetes and abdominal obesity will be randomized to either a donation group (DON) or a control group (CONT) in a double-blind fashion (RCT).
Insulin sensitivity during an oral glucose tolerance test (OGTT) and isotopically measured rate of appearance of endogenous and exogenous glucose will be measured on 2 occasions.
Indexes of the bodily iron stores will be measured after DON/CONT to evaluate if the primary treatment was effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DONATION GROUP | Active Comparator | Participants will be measured before and after a standard blood bank donation (450 mL of whole blood withdrawal) |
|
| CONTROL GROUP | Sham Comparator | Participants will be measured before and after a sham blood donation (0 mL of whole blood withdrawal) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole blood standard donation | Procedure | Effects of a standard whole blood donation on iron stores and insulin sensitivity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity during an oral glucose tolerance test (OGTT) | Measured with the calculations of Matsuda index | 7 months |
| Ferritin blood level | iron stores index measured in blood | 7 months |
| Turnover rate of endogenous and exogenous glucose | Measured using isotopic tracers. | 7 months |
| Carbohydrate oxidation | Measured using indirect calorimetry | 7 months |
| Continuous glucose monitoring | Interstitial blood glucose concentrations during 24-h | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cuality of life | Measured by SF 12 | 7 months |
| Fasting lipid profile | blood analysis | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Castilla-La Mancha (Exercise Physiology Lab) | Toledo | Toledo | 45071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Moreno-Navarrete, J. M., M. Moreno, J. Puig, G. Blasco, F. Ortega, G. Xifra, W. Ricart and J. M. Fernandez-Real (2017). | ||
| Background | Van Pelt, D. W., S. A. Newsom, S. Schenk and J. F. Horowitz (2015). |
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data will be shared upon reasonable request.
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized, control group, trial (RCT)
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participants in the control group will have the standard blood bank donation venipuncture, but no blood will be withdrawn (sham donation).
| Body composition (weight and body fat) | TANITA | 7 months |