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. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
89
Effects of a standard whole blood donation on iron stores and insulin sensitivity.
University of Castilla-La Mancha (Exercise Physiology Lab)
Toledo, Toledo, Spain
Insulin sensitivity during an oral glucose tolerance test (OGTT)
Measured with the calculations of Matsuda index
Time frame: 7 months
Ferritin blood level
iron stores index measured in blood
Time frame: 7 months
Turnover rate of endogenous and exogenous glucose
Measured using isotopic tracers.
Time frame: 7 months
Carbohydrate oxidation
Measured using indirect calorimetry
Time frame: 7 months
Continuous glucose monitoring
Interstitial blood glucose concentrations during 24-h
Time frame: 7 months
Cuality of life
Measured by SF 12
Time frame: 7 months
Fasting lipid profile
blood analysis
Time frame: 7 months
Body composition (weight and body fat)
TANITA
Time frame: 7 months
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