The Acute Effect of Low-intensity Movement Breaks on Glycemic Responses in Individuals With Type 2 Diabetes.

Type 2 Diabetes Clinical Trial

Official title:

The Acute Effect of Low-intensity Movement Breaks on Glycemic Responses in Individuals With Type 2 Diabetes: a Randomized Controlled Crossover Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382259
• Other study ID #: H24-Acute-Movement-Breaks
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: July 15, 2025

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: Jonathan P Little, PhD
• Phone: 250.807.9876
• Email: jonathan.little[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 15, 2025
• Est. primary completion date: July 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• Movement breaks
Stretching and mobility-based exercises lasting 1-minute each performed 4 times per day on two consecutive days.

Locations

Country	Name	City	State
Canada	University of British Columbia Okanagan	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24-h glucose concentration assessed using continuous glucose monitoring assessed using continuous glucose monitoring	The mean 24-h glucose per trial will be determined as the average of the two 24-h periods during that specific trial	48-hour EX trial versus the 48-hour CON trial
Secondary	Time in range determined using continuous glucose monitoring	Percentage of time in range (3.9-10 mmol/L)	48-hour EX trial versus the 48-hour CON trial
Secondary	Time above range determined using continuous glucose monitoring	Percentage of time above range (>10 mmol/L)	48-hour EX trial versus the 48-hour CON trial
Secondary	Time below range determined using continuous glucose monitoring	Percentage of time above range (<3.9 mmol/L)	48-hour EX trial versus the 48-hour CON trial
Secondary	Glycemic variability determined using continuous glucose monitoring	Glycemic variability will be assess using the Standard Deviation (SD), mean amplitude of glycemic excursions (MAGE), and the coefficient of variation (CV)	48-hour EX trial versus the 48-hour CON trial
Secondary	Two-hour glucose area under the curve following standardized breakfast, lunch and dinner meals	The incremental area under the curve following breakfast, lunch and dinner (2 h post meal)	48-hour EX trial versus the 48-hour CON trial