Back to resultsBlood Donation Could Improve Insulin Sensitivity (GLUCFER)
Primary Purpose
Ferritin, Insulin Sensitivity, Blood Donation
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Whole blood standard donation
Sponsored by
About this trial
This is an interventional treatment trial for Ferritin
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
Sites / Locations
- University of Castilla-La Mancha (Exercise Physiology Lab)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
DONATION GROUP
CONTROL GROUP
Arm Description
Participants will be measured before and after a standard blood bank donation (450 mL of whole blood withdrawal)
Participants will be measured before and after a sham blood donation (0 mL of whole blood withdrawal)
Outcomes
Primary Outcome Measures
Insulin sensitivity during an oral glucose tolerance test (OGTT)
Measured with the calculations of Matsuda index
Ferritin blood level
iron stores index measured in blood
Turnover rate of endogenous and exogenous glucose
Measured using isotopic tracers.
Carbohydrate oxidation
Measured using indirect calorimetry
Continuous glucose monitoring
Interstitial blood glucose concentrations during 24-h
Secondary Outcome Measures
Cuality of life
Measured by SF 12
Fasting lipid profile
blood analysis
Body composition (weight and body fat)
TANITA
Full Information
NCT ID
NCT05791968
First Posted
March 17, 2023
Last Updated
March 30, 2023
Sponsor
University of Castilla-La Mancha
Collaborators
SESCAM Centro Regional de Transfusión Toledo-Guadalajara.
1. Study Identification
Unique Protocol Identification Number
NCT05791968
Brief Title
Blood Donation Could Improve Insulin Sensitivity
Acronym
GLUCFER
Official Title
Effects of a Standard Blood Bank Donation on Insulin Sensitivity in Adults With Pre-diabetes and Abdominal Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Castilla-La Mancha
Collaborators
SESCAM Centro Regional de Transfusión Toledo-Guadalajara.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ferritin, Insulin Sensitivity, Blood Donation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, control group, trial (RCT)
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
participants in the control group will have the standard blood bank donation venipuncture, but no blood will be withdrawn (sham donation).
Allocation
Randomized
Enrollment
92 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DONATION GROUP
Arm Type
Active Comparator
Arm Description
Participants will be measured before and after a standard blood bank donation (450 mL of whole blood withdrawal)
Arm Title
CONTROL GROUP
Arm Type
Sham Comparator
Arm Description
Participants will be measured before and after a sham blood donation (0 mL of whole blood withdrawal)
Intervention Type
Procedure
Intervention Name(s)
Whole blood standard donation
Intervention Description
Effects of a standard whole blood donation on iron stores and insulin sensitivity.
Primary Outcome Measure Information:
Title
Insulin sensitivity during an oral glucose tolerance test (OGTT)
Description
Measured with the calculations of Matsuda index
Time Frame
7 months
Title
Ferritin blood level
Description
iron stores index measured in blood
Time Frame
7 months
Title
Turnover rate of endogenous and exogenous glucose
Description
Measured using isotopic tracers.
Time Frame
7 months
Title
Carbohydrate oxidation
Description
Measured using indirect calorimetry
Time Frame
7 months
Title
Continuous glucose monitoring
Description
Interstitial blood glucose concentrations during 24-h
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Cuality of life
Description
Measured by SF 12
Time Frame
7 months
Title
Fasting lipid profile
Description
blood analysis
Time Frame
7 months
Title
Body composition (weight and body fat)
Description
TANITA
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo Mora-Rodriguez, PhD
Phone
925268800
Email
ricardo.mora@uclm.es
First Name & Middle Initial & Last Name or Official Title & Degree
Diego Mora-González, RN
Phone
675424515
Email
diego.mora2@alu.uclm.es
Facility Information:
Facility Name
University of Castilla-La Mancha (Exercise Physiology Lab)
City
Toledo
ZIP/Postal Code
45071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Mora-Rodriguez, PhD
Phone
92526800
Ext
5515
Email
ricardo.mora@uclm.es
First Name & Middle Initial & Last Name & Degree
Felix Morales-Palomo, PhD
Phone
+3492526800
Ext
5515
Email
felix.morales@uclm.es
First Name & Middle Initial & Last Name & Degree
Maria C Muñoz-Turrillas, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ricardo Mora-Rodriguez, PhD
First Name & Middle Initial & Last Name & Degree
Diego Mora-Gonzalez, RN
First Name & Middle Initial & Last Name & Degree
Felix Morales-Palomo, PhD
First Name & Middle Initial & Last Name & Degree
Laura Alvarez-Jimenez, RD
First Name & Middle Initial & Last Name & Degree
Juan F Ortega, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
data will be shared upon reasonable request.
Citations:
Citation
Moreno-Navarrete, J. M., M. Moreno, J. Puig, G. Blasco, F. Ortega, G. Xifra, W. Ricart and J. M. Fernandez-Real (2017).
Results Reference
background
PubMed Identifier
24785103
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.
Results Reference
background
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Blood Donation Could Improve Insulin Sensitivity
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