Clinical trial NCT06382259: The Acute Effect of Low-intensity Movement Breaks on Glycemic Responses in Individuals With Type 2 Diabetes.
Official title: The Acute Effect of Low-intensity Movement Breaks on Glycemic Responses in Individuals With Type 2 Diabetes: a Randomized Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2024-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To conduct a randomized crossover trial to determine the acute impact of low-intensity movement breaks on glycemic control in physically inactive individuals living with type 2 diabetes using continuous glucose monitoring.

Detailed description: 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 low-intensity movement breaks per day on two consecutive days (i.e., Monday and Tuesday). The movement breaks will each be 1-minute in duration and consist of stretching and mobility-based exercises. 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.

Eligibility criteria: Inclusion Criteria:

* 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/m2.
* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Mean 24-h glucose concentration assessed using continuous glucose monitoring assessed using continuous glucose monitoring
timeFrame: 48-hour EX trial versus the 48-hour CON trial
Secondary outcomes:
measure: Time in range determined using continuous glucose monitoring
timeFrame: 48-hour EX trial versus the 48-hour CON trial
measure: Time above range determined using continuous glucose monitoring
timeFrame: 48-hour EX trial versus the 48-hour CON trial
measure: Time below range determined using continuous glucose monitoring
timeFrame: 48-hour EX trial versus the 48-hour CON trial
measure: Glycemic variability determined using continuous glucose monitoring
timeFrame: 48-hour EX trial versus the 48-hour CON trial
measure: Two-hour glucose area under the curve following standardized breakfast, lunch and dinner meals
timeFrame: 48-hour EX trial versus the 48-hour CON trial
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jonathan Little, PhD
role: PRINCIPAL_INVESTIGATOR
References: