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OpenTrials
Completed

NCT Number: NCT05791968

Blood Donation Could Improve Insulin Sensitivity

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.

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Key information

Conditions

Ferritin Blood Donation Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Castilla-La Mancha (Exercise Physiology Lab)

Toledo, 45071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole blood standard donation

Procedure

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

Primary outcomes

  1. Insulin sensitivity during an oral glucose tolerance test (OGTT)

    Time frame: 7 months

    Measured with the calculations of Matsuda index

  2. Ferritin blood level

    Time frame: 7 months

    iron stores index measured in blood

  3. Turnover rate of endogenous and exogenous glucose

    Time frame: 7 months

    Measured using isotopic tracers.

  4. Carbohydrate oxidation

    Time frame: 7 months

    Measured using indirect calorimetry

  5. Continuous glucose monitoring

    Time frame: 7 months

    Interstitial blood glucose concentrations during 24-h

Secondary outcomes

  1. Cuality of life

    Time frame: 7 months

    Measured by SF 12

  2. Fasting lipid profile

    Time frame: 7 months

    blood analysis

  3. Body composition (weight and body fat)

    Time frame: 7 months

    TANITA

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • SESCAM Centro Regional de Transfusión Toledo-Guadalajara.

Registry information

Official study title

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

Acronym: GLUCFER

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 30, 2023
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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