- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07928531
Acute Blood Flow Restriction Walking on Immune Cell Phenotype and Function
Impact of Acute Blood Flow Restriction Walking on Immune Cell Phenotype and Function in Adults withT2D
To conduct a randomized control trial to determine the impact of acute blood flow restriction treadmill walking on immune cell counts, function, and phenotype in adults living with type 2 diabetes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will be randomized to a regular treadmill walking condition or treadmill walking with blood flow restriction (BFR) condition. In both groups participants will complete 32 minutes of treadmill walking at a speed and grade that 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 60%. Blood samples will be obtained pre-exercise (PRE), during the final 2 minutes of the final occlusion cycle (OCC), and 3 minutes into the recovery period post-exercise (POST) to measure outcomes.
Study Type
Enrollment (Estimated)
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
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 19-64 years
- Diagnosed with type 2 diabetes with current HbA1c 5.7-9.0%
- Completing <150 minutes of moderate-vigorous physical activity per week.
Exclusion Criteria:
- Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.
- Unstable type 2 diabetes medication of the last 3 months
- Absolute contraindications to BFR (i.e., peripheral vascular disease)
- A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions
- A diagnosis of any red blood cell-altering condition (i.e., sickle cell anemia, poikilocytosis)
- Currently living with any cardiovascular disease, which would impact the ability to participate in exercise safely
- 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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treadmill walking with blood flow restriction
Treadmill walking with blood flow restriction. |
Participants will complete 32 minutes of treadmill walking at a speed and grade that elicit 40-50% heart rate reserve. 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 60%. |
|
Active Comparator: Treadmill Walking
Treadmill walking. |
Participants will complete 32 minutes of treadmill walking at a speed and grade that elicit 40-50% heart rate reserve. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in white blood cell count before, during, and after exercise.
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The white blood cell count will be measured using a hematology analyzer before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in monocyte count before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The monocyte count will be measured using a hematology analyzer before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in neutrophil count before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The neutrophil count will be measured using a hematology analyzer before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in eosinophil count before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The eosinophil count will be measured using a hematology analyzer before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in CD66b+ expression before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The CD66b+ expression will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in CD11b+ expression before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The CD11b+ expression will be measured using flow cytometer before, during, and after exercise |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in CD63+ expression before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The CD63+ expression will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in % of classical monocytes before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The % of classical monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in % of intermediate monocytes before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The % of intermediate monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in % of non-classical monocytes before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The % of non-classical monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in TLR-4 expression on classical monocytes before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The TLR-4 expression on classical monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in TLR-4 expression on intermediate monocytes before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The TLR-4 expression on intermediate monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in TLR-4 expression on non-classical monocytes before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The TLR-4 expression on non-classical monocytes will be measured using flow cytometry before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in plasma IL-6 before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The plasma IL-6 concentration will be measured using a multiplex assay before, during, and after exercise |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in plasma IL-10 before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The plasma IL-10 concentration will be measured using a multiplex assay before, during, and after exercise. |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in plasma TNF-α before, during, and after exercise
Time Frame: Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
The plasma TNF-α concentration will be measured using a multiplex assay before, during, and after exercise |
Pre-exercise, during 32 minute of exercise, immediately post-exercise
|
|
Change in 4-h LPS-induced TNF-α before and after exercise
Time Frame: Pre-exercise, immediately post-exercise
|
The LPS-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA before and after exercise. |
Pre-exercise, immediately post-exercise
|
|
Change in 4-h LPS+IL10-induced TNF-α before and after exercise
Time Frame: Pre-exercise, immediately post-exercise
|
The LPS+IL10-induced TNF-α concentration will be measured from whole-blood culture supernatant using an ELISA before and after exercise. |
Pre-exercise, immediately post-exercise
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H25-02870 acute
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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