Type 2 DiabetesNCT07676305
6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
A study testing Exercise with BFR and Exercise in people with Type 2 Diabetes, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exercise with BFR and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 11 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia Okanagan
Kelowna, British Columbia, V1V 1V7
Jonathan P Little, PhD, 250-807-9876, jonathan.little@ubc.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Exercise with BFR, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with BFROther
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. The treadmill speed and grade will be set to elicit 40-50% heart rate reserve. The BFR 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.
ExerciseOther
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. The treadmill speed and grade will be set to elicit 40-50% heart rate reserve.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill walking with blood flow restriction | Experimental | Treadmill walking with blood flow restriction performed 3 days per week for 6 weeks. Receives: Other: Exercise with BFR |
| Treadmill Walking | Active comparator | Treadmill walking performed 3 days per week for 6 weeks. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-6 weeks
Secondary outcomes (26)
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.
Measured: 0-6 weeks
Change in CD8 expression before and after the 6-week intervention
0-6 weeks
Measured: 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.
Measured: 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.
Measured: 0-6 weeks
Change in % of Th2 cells before and after the 6-week intervention
0-6 weeks
Measured: 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.
Measured: 0-6 weeks
Change in CD66b+ expression before and after the 6-week intervention
0-6 weeks
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start11 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Little, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676305
- Sponsor's protocol ID
- H25-02870-chronic
- Status last verified
- Oct 2026
- First submitted
- 23 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics in Adults withT2D
- ClinicalTrials.gov ID
- NCT07676305
- Acronym / sponsor ID
- H25-02870-chronic
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill walking with blood flow restriction | Experimental | Other: Exercise with BFRTreadmill walking with blood flow restriction performed 3 days per week for 6 weeks. |
| Treadmill Walking | Active comparator | Other: ExerciseTreadmill walking performed 3 days per week for 6 weeks. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise with BFRParticipants 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. The treadmill speed and grade will be set to elicit 40-50% heart rate reserve. The BFR 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. | Other | Treadmill walking with blood flow restriction |
| ExerciseParticipants 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. The treadmill speed and grade will be set to elicit 40-50% heart rate reserve. | Other | Treadmill Walking |
Primary outcome
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.
26 secondary outcomes
Change in CD4 expression before and after the 6-week intervention
Time frame: 0-6 weeks
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.
Change in % of T regulatory cells before and after the 6-week intervention
Time frame: 0-6 weeks
Change in % of Th1 cells before and after the 6-week intervention
Time frame: 0-6 weeks
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.
Change in % of Th17 cells before and after the 6-week intervention
Time frame: 0-6 weeks
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.
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.
Change in CD63+ expression before and after the 6-week intervention
Time frame: 0-6 weeks
Change in % of classical monocytes before and after the 6-week intervention
Time frame: 0-6 weeks
Change in % of intermediate monocytes before and after the 6-week intervention
Time frame: 0-6 weeks
Change in % of non-classical monocytes before and after the 6-week intervention
Time frame: 0-6 weeks
Change in TLR-4 expression on classical monocytes before and after the 6-week intervention
Time frame: 0-6 weeks
Change in TLR-4 expression on intermediate monocytes before and after the 6-week intervention
Time frame: 0-6 weeks
Change in TLR-4 expression on non-classical monocytes before and after the 6-week intervention
Time frame: 0-6 weeks
Change in white blood cell count before and after the 6-week intervention
Time frame: 0-6 weeks
Change in monocyte count before and after the 6-week intervention
Time frame: 0-6 weeks
Change in neutrophil count before and after the 6-week intervention
Time frame: 0-6 weeks
Change in eosinophil count before and after the 6-week intervention
Time frame: 0-6 weeks
Change in plasma IL-6 before and after the 6-week intervention
Time frame: 0-6 weeks
Change in plasma IL-10 before and after the 6-week intervention
Time frame: 0-6 weeks
Change in plasma TNF-α before and after the 6-week intervention
Time frame: 0-6 weeks
Change in 4-h LPS-induced TNF-α before and after the 6-week intervention
Time frame: 0-6 weeks
Change in 4-h LPS+IL-10-induced TNF-α before and after the 6-week intervention
Time frame: 0-6 weeks
Change in 24-h CD3/CD28 stimulated INF-γ before and after the 6-week intervention
Time frame: 0-6 weeks
Change in PMA/Ionomysin induced INF-γ before and after the 6-week
Time frame: 0-6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with BFR and Exercise in people with Type 2 Diabetes, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan P Little, PhD (250-807-9876, jonathan.little@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention (time frame: 0-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.