Blood Donation Could Improve Insulin Sensitivity

Not Applicable

Completed

• Conditions: Blood Donation; Ferritin; Insulin Sensitivity
• Interventions: Procedure: Whole blood standard donation

• Registration Number: NCT05791968
• Lead Sponsor: University of Castilla-La Mancha

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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-30
• Study Start: 2023-09-15
• Primary Completion: 2024-04-30
• Study Completion: 2024-07-30
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL GROUP	Whole blood standard donation	Participants will be measured before and after a sham blood donation (0 mL of whole blood withdrawal)
DONATION GROUP	Whole blood standard donation	Participants will be measured before and after a standard blood bank donation (450 mL of whole blood withdrawal)

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity during an oral glucose tolerance test (OGTT)	7 months	Measured with the calculations of Matsuda index
Turnover rate of endogenous and exogenous glucose	7 months	Measured using isotopic tracers.
Carbohydrate oxidation	7 months	Measured using indirect calorimetry
Ferritin blood level	7 months	iron stores index measured in blood
Continuous glucose monitoring	7 months	Interstitial blood glucose concentrations during 24-h

Secondary Outcome Measures

Name	Time	Method
Body composition (weight and body fat)	7 months	TANITA
Cuality of life	7 months	Measured by SF 12
Fasting lipid profile	7 months	blood analysis

Trial Locations

Locations (1)

University of Castilla-La Mancha (Exercise Physiology Lab); 🇪🇸 Toledo, Spain