Blood Donation Could Improve Insulin Sensitivity

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Two weeks prior to DON/CONT 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.

Official Title
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Effects of a Standard Blood Bank Donation on Insulin Sensitivity in Adults With Pre-diabetes and Abdominal Obesity

Conditions
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Ferritin, Insulin Sensitivity, Blood Donation

Intervention / Treatment
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* Procedure: Whole blood standard donation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, control group, trial (RCT)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DONATION GROUP<br>Participants will be measured before and after a standard blood bank donation (450 mL of whole blood withdrawal) | Procedure: Whole blood standard donation<br>* Effects of a standard whole blood donation on iron stores and insulin sensitivity.<br>|
| Sham Comparator: CONTROL GROUP<br>Participants will be measured before and after a sham blood donation (0 mL of whole blood withdrawal) | Procedure: Whole blood standard donation<br>* Effects of a standard whole blood donation on iron stores and insulin sensitivity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cuality of life | Measured by SF 12 | 7 months | 
| Fasting lipid profile | blood analysis | 7 months | 
| Body composition (weight and body fat) | TANITA | 7 months |