NCT05791968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

February 21, 2025

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

March 17, 2023

Last Update Submit

February 19, 2025

Conditions

FerritinInsulin SensitivityBlood Donation

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (3)

  • Cuality of life

    7 months

  • Fasting lipid profile

    7 months

  • Body composition (weight and body fat)

    7 months

Study Arms (2)

DONATION GROUP

ACTIVE COMPARATOR

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

Procedure: Whole blood standard donation

CONTROL GROUP

SHAM COMPARATOR

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

Procedure: Whole blood standard donation

Interventions

Whole blood standard donationPROCEDURE

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

CONTROL GROUPDONATION GROUP

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Castilla-La Mancha (Exercise Physiology Lab)

Toledo, Toledo, 45071, Spain

Location

Related Publications (2)

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

    BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
participants in the control group will have the standard blood bank donation venipuncture, but no blood will be withdrawn (sham donation).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, control group, trial (RCT)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Exercise Physiology Laboratory

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 30, 2023

Study Start

September 15, 2023

Primary Completion

April 30, 2024

Study Completion

July 30, 2024

Last Updated

February 21, 2025

Record last verified: 2023-03

Locations

ES(1)