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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Movement breaks

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan P Little, PhD; Phone Number: 250.807.9876; Email: jonathan.little@ubc.ca

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V 3G1
      • Recruiting
      • University of British Columbia Okanagan
      • Contact: Jonathan Little, PhD; Phone Number: 2508079876; Email: jonathan.little@ubc.ca
      • Contact: Phone Number: 2508079876; Email: jonathan.little@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (CON) Non-exercise control condition; No structured exercise on two consecutive days.
Experimental: Exercise (EX): Low-intensity movement breaks condition; Stretching and mobility-based exercises lasting 1-minute each performed 4 times per day on two consecutive days.	Other: Movement breaks; Stretching and mobility-based exercises lasting 1-minute each performed 4 times per day on two consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: McMaster University
• Investigators: Principal Investigator: Jonathan Little, PhD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: April 19, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: H24-Acute-Movement-Breaks

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No