Blood Donation Could Improve Insulin Sensitivity (GLUCFER)

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

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.

Study Overview

• Status: Completed
• Conditions: Insulin Sensitivity; Blood Donation; Ferritin
• Intervention / Treatment: Procedure: Whole blood standard donation

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 Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Toledo, Spain, 45071
    • University of Castilla-La Mancha (Exercise Physiology Lab)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: SESCAM Centro Regional de Transfusión Toledo-Guadalajara.

Publications and helpful links

General Publications

• Moreno-Navarrete, J. M., M. Moreno, J. Puig, G. Blasco, F. Ortega, G. Xifra, W. Ricart and J. M. Fernandez-Real (2017).
• Van Pelt DW, Newsom SA, Schenk S, Horowitz JF. Relatively low endogenous fatty acid mobilization and uptake helps preserve insulin sensitivity in obese women. Int J Obes (Lond). 2015 Jan;39(1):149-55. doi: 10.1038/ijo.2014.70. Epub 2014 May 2.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Immune System Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Hypersensitivity; Insulin Resistance
• Other Study ID Numbers: CEIC-CHUT-969

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: data will be shared upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No