The Canadian E-PAraDiGM (Exercise Physical Activity and Diabetes Glucose Monitoring) Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 79
- Locations
- 2
- Primary Endpoint
- Mean 24 hour glucose levels (mmol/l)
Study Overview
Brief Summary
Walking is encouraged for people with type 2 diabetes but there is little evidence that performing a bout of walking can improve glucose control. Furthermore, it is unknown how participant characteristics (e.g., age, sex, medications) impact the acute glucose responses to walking in people with type 2 diabetes. The primary purpose of this study is to examine how a standardized bout of walking impacts glucose control assessed over 24 hours using continuous glucose monitoring. A secondary purpose is to determine whether responses are influenced by age, sex, and medication use.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with T2D for more than 6 months
- •30-90 years of age
- •No contra-indications to exercise (PAR-Q+, Rose Angina questionnaire, limited ability to walk for 50 min).
- •No previous myocardial infarction, stroke or diagnosed coronary artery disease
- •No changes in diabetes medication in last 3 months
- •Not treated by insulin or corticosteroids
- •No significant change in body weight (>5%) in last 3 months
- •Blood pressure <160/100 mmHg; resting HR<100
- •Able to understand English or French and comply with study requirements (e.g., attend visits during the day)
- •Hemoglobin A1C <9.0%
- •No prior history of hypoglycaemia during activity or sleep
Exclusion Criteria
- •Chest pain during physical activity.
- •Chest pain while resting (no physical activity) in the past month.
- •Loss of balance or consciousness because of dizziness in past 12 months
- •Bone or joint problem (for example, back, knee, or hip) that could be made worse by a change in physical activity.
- •Currently pregnant or planning on becoming pregnant in the next 3 months
- •Currently taking exogenous insulin
- •Previous heart attack or stroke
- •Any other reason that prevents ability to walk on a treadmill for 50 minutes
Arms & Interventions
Walking
Walking on a treadmill at 3.5 metabolic equivalents (METS) for 50 minutes
Intervention: Walking (Behavioral)
Seated Control
Sitting for 50 minutes
Intervention: Seated Control (Behavioral)
Outcomes
Primary Outcomes
Mean 24 hour glucose levels (mmol/l)
Time Frame: 24 hours
Mean glucose assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring
Secondary Outcomes
- Mean amplitude of glycemic excursions (MAGE)(24 hours)
- Standard Deviation of Glucose Values(24 hours)
- Post-dinner glucose control(2 hours following dinner)
- Post-lunch glucose control(2 hours following lunch)
- Post-breakfast glucose control(2 hour following breakfast)
- Time spent above 10 mmol/l glucose(24 hours following walking or seated control)
Investigators
Jonathan Little
Assistant Professor
University of British Columbia