Blood Donation, Ferritin, Insulin Sensitivity
Conditions
Brief summary
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.
Detailed description
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. 1. Two weeks prior to DON/CONT 2. Two weeks after to DON/CONT Indexes of the bodily iron stores will be measured after DON/CONT to evaluate if the primary treatment was effective.
Interventions
PROCEDUREWhole blood standard donation
Effects of a standard whole blood donation on iron stores and insulin sensitivity.
Sponsors
SESCAM Centro Regional de Transfusión Toledo-Guadalajara.
University of Castilla-La Mancha
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
participants in the control group will have the standard blood bank donation venipuncture, but no blood will be withdrawn (sham donation).
Intervention model description
Randomized, control group, trial (RCT)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* have not donated in the last 3 months * IMC\>25 * fasting blood glucose 100-125 mg/dL * glycosylated hemoglobin levels between 5.7-6.4%
Exclusion criteria
* to not meet donor bank requirements * insulin treatment for diabetes * anemia * hereditary hemochromatosis * heart disease * familial hypertriglyceridemia or hypobetalipoproteinemia * any disease that requires medication that interferes with iron or glucose metabolism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous glucose monitoring | 7 months | Interstitial blood glucose concentrations during 24-h |
| Ferritin blood level | 7 months | iron stores index measured in blood |
| Turnover rate of endogenous and exogenous glucose | 7 months | Measured using isotopic tracers. |
| Carbohydrate oxidation | 7 months | Measured using indirect calorimetry |
| Insulin sensitivity during an oral glucose tolerance test (OGTT) | 7 months | Measured with the calculations of Matsuda index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting lipid profile | 7 months | blood analysis |
| Body composition (weight and body fat) | 7 months | TANITA |
| Cuality of life | 7 months | Measured by SF 12 |
Countries
Spain
Outcome results
None listed