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

NCT06382259 | Recruiting

• 1 other identifier: H24-Acute-Movement-Breaks
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time in range determined using continuous glucose monitoring

  48-hour EX trial versus the 48-hour CON trial

• Time above range determined using continuous glucose monitoring

  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

• 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

Study Arms (2)

Exercise (EX): Low-intensity movement breaks condition

EXPERIMENTAL

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

Other: Movement breaks

Control (CON) Non-exercise control condition

NO INTERVENTION

No structured exercise on two consecutive days.

Interventions

Movement breaks OTHER

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

Exercise (EX): Low-intensity movement breaks condition

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of British Columbia: lead
• McMaster University: collaborator

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V 3G1, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jonathan Little, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan P Little, PhD

CONTACT

250.807.9876; jonathan.little@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: April 25, 2024
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)