Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07676305

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

Location status: Recruiting

Location contact

Jonathan P Little, PhD

CONTACT

[email protected]

250-807-9876

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Other

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.

Primary outcomes

  1. Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention

    Time frame: 0-6 weeks

    T-cell OCR will be measured using a Seahorse Analyzer at baseline and after the 6-week intervention.

Secondary outcomes

  1. Change in CD4 expression before and after the 6-week intervention

    Time frame: 0-6 weeks

    The CD4 expression will be measured using flow cytometry at baseline and after the 6-week intervention.

  2. Change in CD8 expression before and after the 6-week intervention

    Time frame: The CD8 expression will be measured using flow cytometry at baseline and after the 6-week intervention.

    0-6 weeks

  3. Change in % of T regulatory cells before and after the 6-week intervention

    Time frame: 0-6 weeks

    The % T regulatory cells will be measured using flow cytometry at baseline and after the 6-week intervention.

  4. Change in % of Th1 cells before and after the 6-week intervention

    Time frame: 0-6 weeks

    The % Th1 cells will be measured using flow cytometry at baseline and after the 6-week intervention.

  5. Change in % of Th2 cells before and after the 6-week intervention

    Time frame: The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention.

    0-6 weeks

  6. Change in % of Th17 cells before and after the 6-week intervention

    Time frame: 0-6 weeks

    The % Th17 cells will be measured using flow cytometry at baseline and after the 6-week intervention.

  7. Change in CD66b+ expression before and after the 6-week intervention

    Time frame: The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.

    0-6 weeks

  8. Change in CD11b+ expression before and after the 6-week intervention

    Time frame: The CD11b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.

    0-6 weeks

  9. Change in CD63+ expression before and after the 6-week intervention

    Time frame: 0-6 weeks

    The CD63+ expression will be measured using flow cytometry at baseline and after the 6-week intervention.

  10. Change in % of classical monocytes before and after the 6-week intervention

    Time frame: 0-6 weeks

    The % of classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.

  11. Change in % of intermediate monocytes before and after the 6-week intervention

    Time frame: 0-6 weeks

    The % of intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.

  12. Change in % of non-classical monocytes before and after the 6-week intervention

    Time frame: 0-6 weeks

    The % of non-classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.

  13. Change in TLR-4 expression on classical monocytes before and after the 6-week intervention

    Time frame: 0-6 weeks

    The TLR-4 expression on classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.

  14. Change in TLR-4 expression on intermediate monocytes before and after the 6-week intervention

    Time frame: 0-6 weeks

    The TLR-4 expression on intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.

  15. Change in TLR-4 expression on non-classical monocytes before and after the 6-week intervention

    Time frame: 0-6 weeks

    The TLR-4 expression on non-classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention.

  16. Change in white blood cell count before and after the 6-week intervention

    Time frame: 0-6 weeks

    The white blood cell count will be measured using a hematology analyzer at baseline and after the 6-week intervention.

  17. Change in monocyte count before and after the 6-week intervention

    Time frame: 0-6 weeks

    The monocyte count will be measured using a hematology analyzer at baseline and after the 6-week intervention.

  18. Change in neutrophil count before and after the 6-week intervention

    Time frame: 0-6 weeks

    The neutrophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.

  19. Change in eosinophil count before and after the 6-week intervention

    Time frame: 0-6 weeks

    The eosinophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention.

  20. Change in plasma IL-6 before and after the 6-week intervention

    Time frame: 0-6 weeks

    The plasma IL-6 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.

  21. Change in plasma IL-10 before and after the 6-week intervention

    Time frame: 0-6 weeks

    The plasma IL-10 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.

  22. Change in plasma TNF-α before and after the 6-week intervention

    Time frame: 0-6 weeks

    The plasma TNF-α concentration will be measured using a multiplex assay at baseline and after the 6-week intervention.

  23. Change in 4-h LPS-induced TNF-α before and after the 6-week intervention

    Time frame: 0-6 weeks

    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.

  24. Change in 4-h LPS+IL-10-induced TNF-α before and after the 6-week intervention

    Time frame: 0-6 weeks

    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.

  25. Change in 24-h CD3/CD28 stimulated INF-γ before and after the 6-week intervention

    Time frame: 0-6 weeks

    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.

  26. Change in PMA/Ionomysin induced INF-γ before and after the 6-week

    Time frame: 0-6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan P Little, PhD

CONTACT

[email protected]

250-807-9876

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.