Blood Donation Could Improve Insulin Sensitivity

NCT ID: NCT05791968

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-07-30

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.

Conditions

Ferritin; Insulin Sensitivity; Blood Donation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

DONATION GROUP

Participants will be measured before and after a standard blood bank donation (450 mL of whole blood withdrawal)

Group Type: ACTIVE_COMPARATOR

Whole blood standard donation

Intervention Type: PROCEDURE

Effects of a standard whole blood donation on iron stores and insulin sensitivity.

CONTROL GROUP

Participants will be measured before and after a sham blood donation (0 mL of whole blood withdrawal)

Group Type: SHAM_COMPARATOR

Whole blood standard donation

Intervention Type: PROCEDURE

Effects of a standard whole blood donation on iron stores and insulin sensitivity.

Interventions

Whole blood standard donation

Effects of a standard whole blood donation on iron stores and insulin sensitivity.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SESCAM Centro Regional de Transfusión Toledo-Guadalajara.

UNKNOWN

Sponsor Role: collaborator

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

Ricardo Mora

Director of Exercise Physiology Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Castilla-La Mancha (Exercise Physiology Lab)

Toledo, Toledo, Spain

Countries

Spain

References

Moreno-Navarrete, J. M., M. Moreno, J. Puig, G. Blasco, F. Ortega, G. Xifra, W. Ricart and J. M. Fernandez-Real (2017).

Reference Type: BACKGROUND

Van Pelt, D. W., S. A. Newsom, S. Schenk and J. F. Horowitz (2015).

Reference Type: BACKGROUND

Other Identifiers

CEIC-CHUT-969

Identifier Type: -

Identifier Source: org_study_id