Clinical trial NCT05791968: Blood Donation Could Improve Insulin Sensitivity
Official title: Effects of a Standard Blood Bank Donation on Insulin Sensitivity in Adults With Pre-diabetes and Abdominal Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ferritin
Insulin Sensitivity
Blood Donation
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: SESCAM Centro Regional de Transfusión Toledo-Guadalajara.
First posted: 2023-03-30
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, control group, trial (RCT)
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insulin sensitivity during an oral glucose tolerance test (OGTT)
timeFrame: 7 months
measure: Ferritin blood level
timeFrame: 7 months
measure: Turnover rate of endogenous and exogenous glucose
timeFrame: 7 months
measure: Carbohydrate oxidation
timeFrame: 7 months
measure: Continuous glucose monitoring
timeFrame: 7 months
Secondary outcomes:
measure: Cuality of life
timeFrame: 7 months
measure: Fasting lipid profile
timeFrame: 7 months
measure: Body composition (weight and body fat)
timeFrame: 7 months
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: University of Castilla-La Mancha (Exercise Physiology Lab)
Study officials:
References:
citation: Moreno-Navarrete, J. M., M. Moreno, J. Puig, G. Blasco, F. Ortega, G. Xifra, W. Ricart and J. M. Fernandez-Real (2017).
citation: 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.