FerritinGLUCFERNCT05791968
Blood Donation Could Improve Insulin Sensitivity
A study testing Whole blood standard donation in people with Ferritin and Insulin Sensitivity, run by University of Castilla-La Mancha at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ferritin, Insulin Sensitivity, Blood Donation
- What is being tested?
- Whole blood standard donation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Castilla-La Mancha (Exercise Physiology Lab)
Toledo, Toledo, 45071
About this study
Official title: 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.
Read the 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.
- 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.
- Conditions
- Ferritin, Insulin Sensitivity, Blood Donation
- Being tested
- Whole blood standard donation
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole blood standard donationProcedure or surgery
Effects of a standard whole blood donation on iron stores and insulin sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| DONATION GROUP | Active comparator | Participants will be measured before and after a standard blood bank donation (450 mL of whole blood withdrawal) Receives: 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) Receives: Procedure: Whole blood standard donation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity during an oral glucose tolerance test (OGTT)
Measured with the calculations of Matsuda index
Measured: 7 months
Ferritin blood level
iron stores index measured in blood
Measured: 7 months
Turnover rate of endogenous and exogenous glucose
Measured using isotopic tracers.
Measured: 7 months
Carbohydrate oxidation
Measured using indirect calorimetry
Measured: 7 months
Continuous glucose monitoring
Interstitial blood glucose concentrations during 24-h
Measured: 7 months
Secondary outcomes (3)
Cuality of life
Measured by SF 12
Measured: 7 months
Fasting lipid profile
blood analysis
Measured: 7 months
Body composition (weight and body fat)
TANITA
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start15 Sep 2023
- Primary completion30 Apr 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FerritinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, control group, trial (RCT)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- SESCAM Centro Regional de Transfusión Toledo-Guadalajara.
- Responsible party
- Principal investigator, Ricardo Mora, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791968
- Sponsor's protocol ID
- CEIC-CHUT-969
- Acronym
- GLUCFER
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be shared upon reasonable request.
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, D. W., S. A. Newsom, S. Schenk and J. F. Horowitz (2015).
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Standard Blood Bank Donation on Insulin Sensitivity in Adults With Pre-diabetes and Abdominal Obesity
- ClinicalTrials.gov ID
- NCT05791968
- Acronym / sponsor ID
- GLUCFER / CEIC-CHUT-969
- Conditions
- Ferritin, Insulin Sensitivity, Blood Donation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- SESCAM Centro Regional de Transfusión Toledo-Guadalajara.
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, control group, trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| DONATION GROUP | Active comparator | Procedure: Whole blood standard donationParticipants will be measured before and after a standard blood bank donation (450 mL of whole blood withdrawal) |
| CONTROL GROUP | Sham comparator | Procedure: Whole blood standard donationParticipants will be measured before and after a sham blood donation (0 mL of whole blood withdrawal) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (7 listed)
- to not meet donor bank requirements
- insulin treatment for diabetes
- anemia
- hereditary hemochromatosis
- heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole blood standard donationEffects of a standard whole blood donation on iron stores and insulin sensitivity. | Procedure or surgery | CONTROL GROUP, DONATION GROUP |
Primary outcome
Insulin sensitivity during an oral glucose tolerance test (OGTT)
Time frame: 7 months
Measured with the calculations of Matsuda index
Ferritin blood level
Time frame: 7 months
iron stores index measured in blood
Turnover rate of endogenous and exogenous glucose
Time frame: 7 months
Measured using isotopic tracers.
Carbohydrate oxidation
Time frame: 7 months
Measured using indirect calorimetry
Continuous glucose monitoring
Time frame: 7 months
Interstitial blood glucose concentrations during 24-h
3 secondary outcomes
Cuality of life
Time frame: 7 months
Fasting lipid profile
Time frame: 7 months
Body composition (weight and body fat)
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- BackgroundMoreno-Navarrete, J. M., M. Moreno, J. Puig, G. Blasco, F. Ortega, G. Xifra, W. Ricart and J. M. Fernandez-Real (2017).
- BackgroundVan Pelt, D. W., S. A. Newsom, S. Schenk and J. F. Horowitz (2015).
- Individual participant dataSharing planned: Undecided. data will be shared upon reasonable request.
Related trials for Ferritin
Not yet recruitingObservational study
Cohort of Repeat Donor Experiences (CORE) Study
Fatigue, Acute Illness
Recruiting
A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females
Iron Deficiencies, Low Ferritin
Recruiting
The Effect of Serum Ferritin in irAE
Immune-related Adverse Event, Malignant Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole blood standard donation in people with Ferritin and Insulin Sensitivity, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity during an oral glucose tolerance test (OGTT) (time frame: 7 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05791968, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025; AzTrials last refreshed its copy on 29 Oct 2026.