6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics

Impact of 6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics in Adults withT2D

To conduct a randomized control trial to determine the impact of 6-weeks of blood flow restriction training on immune cell function and bioenergetics in adults living with type 2 diabetes.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Exercise

Detailed Description

Participants will be randomized to a regular treadmill walking group or treadmill walking with blood flow restriction (BFR) group for 6 weeks. In both groups participants will complete treadmill walking on 3 days per week for 6 weeks. During week 1 participants will walk for 21 minutes during each session which will be increased to 32 minutes for the remaining 5 weeks of the study. In both groups the treadmill speed and grade will be set to elicit 40-50% heart rate reserve. In the BFR group the cuffs will be inflated based on each participants individualized limb occlusion pressure (LOP). The cuffs will remain inflated for the entire session but will deflate for 1 minute every 10 minutes based on safety recommendations. The percentage of LOP will progressively increase over the course of the intervention. Weeks 1 and 2 will be completed at 60% LOP, after which pressure will increase by 5% each subsequent week, corresponding to 65%, 70%, 75%, and 80% LOP during weeks 3, 4, 5, and 6, respectively. All outcomes will be assessed at baseline before randomization and at the end of the 6-week intervention.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan P Little, PhD; Phone Number: 250-807-9876; Email: jonathan.little@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V 1V7
      • Recruiting
      • University of British Columbia Okanagan
      • Contact: Jonathan P Little, PhD; Phone Number: 250-807-9876; Email: jonathan.little@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

A. Aged 19-64 years. B. Diagnosed with type 2 diabetes with current HbA1c 5.7-9.0% C. Completing <150 minutes of moderate-vigorous physical activity per week.

Exclusion Criteria:

A. Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.

B. Unstable type 2 diabetes medication of the last 3 months C. Absolute contraindications to BFR (i.e., peripheral vascular disease) D. A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions E. A diagnosis of any red blood cell-altering condition (i.e., sickle cell anemia, poikilocytosis) F. Currently living with any cardiovascular disease, which would impact the ability to participate in exercise safely G. Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track intensity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treadmill walking with blood flow restriction; Treadmill walking with blood flow restriction performed 3 days per week for 6 weeks.	Other: Exercise; In both groups participants will complete treadmill walking on 3 days per week for 6 weeks. During the first week participants will walk continuously for 21 minutes during each training session which will be increased to 32 minutes per training session for weeks 2-6. In both groups the treadmill speed and grade will be set to elicit 40-50% heart rate reserve. In the BFR group the cuffs will be inflated based on each participants individualized limb occlusion pressure (LOP). The cuffs will remain inflated for the entire session but will deflate for 1 min every 10 min based on safety recommendations. The percentage of LOP will progressively increase over the course of the intervention. Weeks 1 and 2 will be completed at 60% LOP, after which pressure will increase by 5% each subsequent week, corresponding to 65%, 70%, 75%, and 80% LOP during weeks 3, 4, 5, and 6, respectively.
Active Comparator: Treadmill Walking; Treadmill walking performed 3 days per week for 6 weeks.	Other: Exercise; In both groups participants will complete treadmill walking on 3 days per week for 6 weeks. During the first week participants will walk continuously for 21 minutes during each training session which will be increased to 32 minutes per training session for weeks 2-6. In both groups the treadmill speed and grade will be set to elicit 40-50% heart rate reserve. In the BFR group the cuffs will be inflated based on each participants individualized limb occlusion pressure (LOP). The cuffs will remain inflated for the entire session but will deflate for 1 min every 10 min based on safety recommendations. The percentage of LOP will progressively increase over the course of the intervention. Weeks 1 and 2 will be completed at 60% LOP, after which pressure will increase by 5% each subsequent week, corresponding to 65%, 70%, 75%, and 80% LOP during weeks 3, 4, 5, and 6, respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention	T-cell OCR will be measured using a Seahorse Analyzer at baseline and after the 6-week intervention.	0-6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CD4 expression before and after the 6-week intervention	The CD4 expression will be measured using flow cytometry at baseline and after the 6-week intervention.	0-6 weeks
Change in CD8 expression before and after the 6-week intervention	0-6 weeks	The CD8 expression will be measured using flow cytometry at baseline and after the 6-week intervention.
Change in % of T regulatory cells before and after the 6-week intervention	The % T regulatory cells will be measured using flow cytometry at baseline and after the 6-week intervention.	0-6 weeks
Change in % of Th1 cells before and after the 6-week intervention	The % Th1 cells will be measured using flow cytometry at baseline and after the 6-week intervention.	0-6 weeks
Change in % of Th2 cells before and after the 6-week intervention	0-6 weeks	The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention.
Change in % of Th17 cells before and after the 6-week intervention	The % Th17 cells will be measured using flow cytometry at baseline and after the 6-week intervention.	0-6 weeks
Change in CD66b+ expression before and after the 6-week intervention	0-6 weeks	The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
Change in CD11b+ expression before and after the 6-week intervention	0-6 weeks	The CD11b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.
Change in CD63+ expression before and after the 6-week intervention	The CD63+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.	0-6 weeks
Change in % of classical monocytes before and after the 6-week intervention	The % of classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.	0-6 weeks
Change in % of intermediate monocytes before and after the 6-week intervention	The % of intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.	0-6 weeks
Change in % of non-classical monocytes before and after the 6-week intervention	The % of non-classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.	0-6 weeks
Change in TLR-4 expression on classical monocytes before and after the 6-week intervention	The TLR-4 expression on classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.	0-6 weeks
Change in TLR-4 expression on intermediate monocytes before and after the 6-week intervention	The TLR-4 expression on intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.	0-6 weeks
Change in TLR-4 expression on non-classical monocytes before and after the 6-week intervention	The TLR-4 expression on non-classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.	0-6 weeks
Change in white blood cell count before and after the 6-week intervention	The white blood cell count will be measured using a hematology analyzer at baseline and after the 6-week intervention.	0-6 weeks
Change in monocyte count before and after the 6-week intervention	The monocyte count will be measured using a hematology analyzer at baseline and after the 6-week intervention.	0-6 weeks
Change in neutrophil count before and after the 6-week intervention	The neutrophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.	0-6 weeks
Change in eosinophil count before and after the 6-week intervention	The eosinophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.	0-6 weeks
Change in plasma IL-6 before and after the 6-week intervention	The plasma IL-6 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.	0-6 weeks
Change in plasma IL-10 before and after the 6-week intervention	The plasma IL-10 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.	0-6 weeks
Change in plasma TNF-α before and after the 6-week intervention	The plasma TNF-α concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.	0-6 weeks
Change in 4-h LPS-induced TNF-α before and after the 6-week intervention	The LPS-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA at baseline and after the 6-week intervention.	0-6 weeks
Change in 4-h LPS+IL-10-induced TNF-α before and after the 6-week intervention	The LPS+IL10-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA at baseline and after the 6-week intervention.	0-6 weeks
Change in 24-h CD3/CD28 stimulated INF-γ before and after the 6-week intervention	The CD3/CD28 stimulated INF-γ concentration will be measured from T-cell culture supernatant using an ELISA at baseline and after the 6-week intervention.	0-6 weeks
Change in PMA/Ionomysin induced INF-γ before and after the 6-week	The PMA/Ionomysin induced INF-γ concentration will be measured from whole-blood culture supernatant using an ELISA at baseline and after the 6-week intervention.	0-6 weeks

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: H25-02870-chronic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No