跳至主要内容
临床试验/NCT06382246
NCT06382246招募中不适用

The Acute Effect of "Exercise Snacks" on Glycemic Responses in Individuals With Type 2 Diabetes: a Randomized Controlled Crossover Trial

University of British Columbia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月20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
30
试验地点
2
主要终点
Mean 24-h glucose concentration assessed using continuous glucose monitoring

研究概览

简要总结

To conduct a randomized crossover trial to determine the acute impact of exercise snacks on glycemic control in physically inactive individuals living with type 2 diabetes using continuous glucose monitoring.

详细描述

Participants will perform two, 48-hour experimental conditions separated by 24 hours while wearing a continuous glucose monitor to measure glycemic responses. The order of the trials will be randomized for each participant. The two trials will include an exercise condition (EX) and a control, non-exercise condition (CON). During the EX trial, participants will perform four exercise snacks per day on two consecutive days (i.e., Monday and Tuesday). Each exercise snack will be 1-minute in duration and consist of bodyweight style exercise performed with vigorous effort. During the CON trial, participants will be asked to refrain from any structured exercise during two consecutive days (i.e., Thursday and Friday). All meals will be provided to participants during the two 48-hour trials and will be standardized for a given participant. There will be a one-day wash out period in between the completion of both trials for all participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 30-75 years old.
  • Have physician-diagnosed type 2 diabetes.
  • Currently participating in less than 150 minutes of moderate-to-vigorous intensity aerobic exercise per week.
  • Have a body mass index between 18.5 and 40 kg/m
  • Have had a stable medication dosage and no changes to the number of prescribed medications for at least 6 months.
  • Able to maintain current medication doses during the study.
  • Able to maintain current physical activity patterns during the study.
  • HbA1c is less than or equal to 8.5%.
  • Have access to a computer, tablet, or smartphone for intervention delivery and tracking.
  • Can travel to McMaster University for in-person laboratory testing visits.
  • Can read, write, and understand English.
  • Anticipate having access to the internet for the duration of the intervention (i.e., over the next 3-4 months).
  • Cleared for exercise participation based on the CSEP Get Active Questionnaire and the Rose Angina Questionnaire.

排除标准

  • Taking 4 or more glucose-lowering medications.
  • Taking insulin.
  • Taking beta-blockers.
  • Taking 3 or more commonly prescribed medications for the prevention of cardiovascular disease (e.g., statins, antihypertensives).
  • Have had an episode of severe hypoglycemia in the past 6 months (defined as having neurological symptoms consistent with neuroglycopenia and required assistance in treatment by a second party).
  • Currently a cigarette smoker.
  • Have a chronic musculoskeletal condition that would prevent participation in exercise.
  • Have had a recent (within the last 2 years) cardiovascular event that prevents participation in exercise.
  • Experience angina upon exertion.
  • Have uncontrolled high blood pressure (hypertension) or an atypical blood pressure or pulse rate at rest or during exercise as determined by a physician.
  • Have a scheduled surgical procedure within the next 3-4 months that would prevent exercise participation.
  • Currently diagnosed with a cardiac or pulmonary disease (e.g., angina, arrythmia, exercise-induced bronchospasm) that would prevent exercise participation.
  • Have a psychiatric disorder that could prevent you from completing the study procedures or visits.
  • Have donated more than 0.5 L of blood within the last 4 weeks.
  • Currently following an extreme diet (e.g., very low carbohydrate/calorie, ketogenic) or taking dietary/nutritional supplements that impact glucose control (e.g., exogenous ketones).
  • Currently have diabetic ulcers, peripheral vascular disease, or diabetic neuropathy that will prevent participation in exercise.
  • Currently on dialysis.
  • Currently participating in another clinical trial that interferes with the study procedures.
  • Currently pregnant or planning on becoming pregnant during the intervention (i.e., within the next 3-4 months).

结局指标

主要结局

Mean 24-h glucose concentration assessed using continuous glucose monitoring

时间窗: 48-hour EX trial versus the 48-hour CON trial

The mean 24-h glucose per trial will be determined as the average of the two 24-h periods during that specific trial.

次要结局

  • Time above range determined using continuous glucose monitoring(48-hour EX trial versus the 48-hour CON trial)
  • Glycemic variability determined using continuous glucose monitoring(48-hour EX trial versus the 48-hour CON trial)
  • Two-hour glucose area under the curve following standardized breakfast, lunch and dinner meals(48-hour EX trial versus the 48-hour CON trial)
  • Time below range determined using continuous glucose monitoring(48-hour EX trial versus the 48-hour CON trial)
  • Time in range determined using continuous glucose monitoring(48-hour EX trial versus the 48-hour CON trial)

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 (2)

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