Effects of a Standard Blood Bank Donation on Insulin Sensitivity in Adults with Pre-diabetes and Abdominal Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 89
- Locations
- 2
- Primary Endpoint
- Insulin sensitivity during an oral glucose tolerance test (OGTT)
Study Overview
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.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, 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participants in the control group will have the standard blood bank donation venipuncture, but no blood will be withdrawn (sham donation).
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •have not donated in the last 3 months
- •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
- •hereditary hemochromatosis
- •heart disease
- •familial hypertriglyceridemia or hypobetalipoproteinemia
- •any disease that requires medication that interferes with iron or glucose metabolism
Outcomes
Primary Outcomes
Insulin sensitivity during an oral glucose tolerance test (OGTT)
Time Frame: 7 months
Measured with the calculations of Matsuda index
Turnover rate of endogenous and exogenous glucose
Time Frame: 7 months
Measured using isotopic tracers.
Carbohydrate oxidation
Time Frame: 7 months
Measured using indirect calorimetry
Ferritin blood level
Time Frame: 7 months
iron stores index measured in blood
Continuous glucose monitoring
Time Frame: 7 months
Interstitial blood glucose concentrations during 24-h
Secondary Outcomes
- Body composition (weight and body fat)(7 months)
- Cuality of life(7 months)
- Fasting lipid profile(7 months)
Investigators
Ricardo Mora
Director of Exercise Physiology Laboratory
University of Castilla-La Mancha