Type 2 Diabetes
Conditions
Brief summary
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.
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.
Interventions
OTHERExercise
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.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention | 0-6 weeks | T-cell OCR will be measured using a Seahorse Analyzer at baseline and after the 6-week intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in CD4 expression before and after the 6-week intervention | 0-6 weeks | The CD4 expression will be measured using flow cytometry at baseline and after the 6-week intervention. |
| Change in CD8 expression before and after the 6-week intervention | The CD8 expression will be measured using flow cytometry at baseline and after the 6-week intervention. | 0-6 weeks |
| Change in % of T regulatory cells before and after the 6-week intervention | 0-6 weeks | The % T regulatory cells will be measured using flow cytometry at baseline and after the 6-week intervention. |
| Change in % of Th1 cells before and after the 6-week intervention | 0-6 weeks | The % Th1 cells will be measured using flow cytometry at baseline and after the 6-week intervention. |
| Change in % of Th2 cells before and after the 6-week intervention | The % Th2 cells will be measured using flow cytometry at baseline and after the 6-week intervention. | 0-6 weeks |
| Change in % of Th17 cells before and after the 6-week intervention | 0-6 weeks | The % Th17 cells will be measured using flow cytometry at baseline and after the 6-week intervention. |
| Change in CD66b+ expression before and after the 6-week intervention | The CD66b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention. | 0-6 weeks |
| Change in CD11b+ expression before and after the 6-week intervention | The CD11b+ expression will be measured using flow cytometry at baseline and after the 6-week intervention. | 0-6 weeks |
| Change in CD63+ expression before and after the 6-week intervention | 0-6 weeks | The CD63+ expression will be measured using flow cytometry at baseline and after the 6-week intervention. |
| Change in % of classical monocytes before and after the 6-week intervention | 0-6 weeks | The % of classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention. |
| Change in % of intermediate monocytes before and after the 6-week intervention | 0-6 weeks | The % of intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention. |
| Change in % of non-classical monocytes before and after the 6-week intervention | 0-6 weeks | The % of non-classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention. |
| Change in TLR-4 expression on classical monocytes before and after the 6-week intervention | 0-6 weeks | The TLR-4 expression on classical monocytes will be measured using flow cytometry at baseline and after the 6-week intervention. |
| Change in TLR-4 expression on intermediate monocytes before and after the 6-week intervention | 0-6 weeks | The TLR-4 expression on intermediate monocytes will be measured using flow cytometry at baseline and after the 6-week intervention. |
| Change in TLR-4 expression on non-classical monocytes before and after the 6-week intervention | 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. |
| Change in white blood cell count before and after the 6-week intervention | 0-6 weeks | The white blood cell count will be measured using a hematology analyzer at baseline and after the 6-week intervention. |
| Change in monocyte count before and after the 6-week intervention | 0-6 weeks | The monocyte count will be measured using a hematology analyzer at baseline and after the 6-week intervention. |
| Change in neutrophil count before and after the 6-week intervention | 0-6 weeks | The neutrophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention. |
| Change in eosinophil count before and after the 6-week intervention | 0-6 weeks | The eosinophil count will be measured using a hematology analyzer at baseline and after the 6-week intervention. |
| Change in plasma IL-6 before and after the 6-week intervention | 0-6 weeks | The plasma IL-6 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention. |
| Change in plasma IL-10 before and after the 6-week intervention | 0-6 weeks | The plasma IL-10 concentration will be measured using a multiplex assay at baseline and after the 6-week intervention. |
| Change in plasma TNF-α before and after the 6-week intervention | 0-6 weeks | The plasma TNF-α concentration will be measured using a multiplex assay at baseline and after the 6-week intervention. |
| Change in 4-h LPS-induced TNF-α before and after the 6-week intervention | 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. |
| Change in 4-h LPS+IL-10-induced TNF-α before and after the 6-week intervention | 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. |
| Change in 24-h CD3/CD28 stimulated INF-γ before and after the 6-week intervention | 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. |
| Change in PMA/Ionomysin induced INF-γ before and after the 6-week | 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. |
Countries
Canada
Contacts
CONTACTJonathan P Little, PhD
Outcome results
None listed