NCT07676305

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
17mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Feb 2026Dec 2027

Study Start

First participant enrolled

February 11, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

June 23, 2026

Last Update Submit

June 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (26)

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

    0-6 weeks

  • 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.

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

    0-6 weeks

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

    0-6 weeks

  • 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.

  • +21 more secondary outcomes

Study Arms (2)

Treadmill walking with blood flow restriction

EXPERIMENTAL

Treadmill walking with blood flow restriction performed 3 days per week for 6 weeks.

Other: Exercise

Treadmill Walking

ACTIVE COMPARATOR

Treadmill walking performed 3 days per week for 6 weeks.

Other: Exercise

Interventions

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.

Treadmill WalkingTreadmill walking with blood flow restriction

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 1V7, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jonathan P Little, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 30, 2026

Study Start

February 11, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 30, 2026

Record last verified: 2026-06

Locations