GLUCFER: Blood Donation Could Improve Insulin Sensitivity

• Sponsor: University of Castilla-La Mancha (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05791968
• Collaborator: SESCAM Centro Regional de Transfusión Toledo-Guadalajara. (Other)
• Enrollment: 92
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 6
• Patients Per Site Per Month: 15.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ferritin; Insulin Sensitivity; Blood Donation	Procedure: Whole blood standard donation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, control group, trial (RCT)Randomized, control group, trial (RCT)
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: participants in the control group will have the standard blood bank donation venipuncture, but no blood will be withdrawn (sham donation).
• Primary Purpose: Treatment
• Official Title: Effects of a Standard Blood Bank Donation on Insulin Sensitivity in Adults With Pre-diabetes and Abdominal Obesity
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Insulin sensitivity during an oral glucose tolerance test (OGTT) [7 months]

   Measured with the calculations of Matsuda index

2. Ferritin blood level [7 months]

   iron stores index measured in blood

3. Turnover rate of endogenous and exogenous glucose [7 months]

   Measured using isotopic tracers.

4. Carbohydrate oxidation [7 months]

   Measured using indirect calorimetry

5. Continuous glucose monitoring [7 months]

   Interstitial blood glucose concentrations during 24-h

Secondary Outcome Measures

1. Cuality of life [7 months]

   Measured by SF 12

2. Fasting lipid profile [7 months]

   blood analysis

3. Body composition (weight and body fat) [7 months]

   TANITA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Castilla-La Mancha (Exercise Physiology Lab)	Toledo		Spain	45071

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Ricardo Mora, Director of Exercise Physiology Laboratory, University of Castilla-La Mancha
• ClinicalTrials.gov Identifier: NCT05791968
• Other Study ID Numbers: CEIC-CHUT-969
• First Posted: Mar 30, 2023
• Last Update Posted: Apr 3, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Insulin Resistance; Hypersensitivity

Study Results

No Results Posted as of Apr 3, 2023