Blood Donation Could Improve Insulin Sensitivity

Insulin Sensitivity Clinical Trial

— GLUCFER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05791968
• Other study ID #: CEIC-CHUT-969
• Status: Recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: March 2024

Study information

• Verified date: March 2023
• Source: University of Castilla-La Mancha
• Contact: Ricardo Mora-Rodriguez, PhD
• Phone: 925268800
• Email: ricardo.mora[@]uclm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Donation
• Ferritin
• Hypersensitivity
• Insulin Resistance
• Insulin Sensitivity

Intervention

Procedure:
• Whole blood standard donation
Effects of a standard whole blood donation on iron stores and insulin sensitivity.

Locations

Country	Name	City	State
Spain	University of Castilla-La Mancha (Exercise Physiology Lab)	Toledo

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	SESCAM Centro Regional de Transfusión Toledo-Guadalajara.

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity during an oral glucose tolerance test (OGTT)	Measured with the calculations of Matsuda index	7 months
Primary	Ferritin blood level	iron stores index measured in blood	7 months
Primary	Turnover rate of endogenous and exogenous glucose	Measured using isotopic tracers.	7 months
Primary	Carbohydrate oxidation	Measured using indirect calorimetry	7 months
Primary	Continuous glucose monitoring	Interstitial blood glucose concentrations during 24-h	7 months
Secondary	Cuality of life	Measured by SF 12	7 months
Secondary	Fasting lipid profile	blood analysis	7 months
Secondary	Body composition (weight and body fat)	TANITA	7 months