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临床试验/NCT07676305
NCT07676305招募中不适用

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

University of British Columbia1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Change in T-cell oxygen consumption rate (OCR) measured before and after the 6-week intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
19 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

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

时间窗: 0-6 weeks

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

次要结局

  • 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.)
  • Change in % of Th17 cells before and after the 6-week intervention(0-6 weeks)
  • 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.)
  • 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.)
  • Change in CD63+ expression before and after the 6-week intervention(0-6 weeks)
  • Change in % of classical monocytes before and after the 6-week intervention(0-6 weeks)
  • Change in % of intermediate monocytes before and after the 6-week intervention(0-6 weeks)
  • Change in % of non-classical monocytes before and after the 6-week intervention(0-6 weeks)
  • Change in TLR-4 expression on classical monocytes before and after the 6-week intervention(0-6 weeks)
  • Change in TLR-4 expression on intermediate monocytes before and after the 6-week intervention(0-6 weeks)
  • Change in TLR-4 expression on non-classical monocytes before and after the 6-week intervention(0-6 weeks)
  • Change in white blood cell count before and after the 6-week intervention(0-6 weeks)
  • Change in monocyte count before and after the 6-week intervention(0-6 weeks)
  • Change in neutrophil count before and after the 6-week intervention(0-6 weeks)
  • Change in eosinophil count before and after the 6-week intervention(0-6 weeks)
  • Change in plasma IL-6 before and after the 6-week intervention(0-6 weeks)
  • Change in plasma IL-10 before and after the 6-week intervention(0-6 weeks)
  • Change in plasma TNF-α before and after the 6-week intervention(0-6 weeks)
  • Change in 4-h LPS-induced TNF-α before and after the 6-week intervention(0-6 weeks)
  • Change in 4-h LPS+IL-10-induced TNF-α before and after the 6-week intervention(0-6 weeks)
  • Change in 24-h CD3/CD28 stimulated INF-γ before and after the 6-week intervention(0-6 weeks)
  • Change in PMA/Ionomysin induced INF-γ before and after the 6-week(0-6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Little

Professor

University of British Columbia

研究点 (1)

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