The Canadian E-PAraDiGM (Exercise Physical Activity and Diabetes Glucose Monitoring) Protocol

Study Overview
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Brief Summary
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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.

Official Title
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The Canadian E-PAraDiGM (Exercise Physical Activity and Diabetes Glucose Monitoring) Protocol

Conditions
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Walking, Seated Control

Intervention / Treatment
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* Behavioral: Walking
* Behavioral: Seated Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking<br>Walking on a treadmill at 3.5 metabolic equivalents (METS) for 50 minutes | Behavioral: Walking<br>* Walking on a treadmill at 3.5 METS for 50 minutes<br>|
| Experimental: Seated Control<br>Sitting for 50 minutes | Behavioral: Seated Control<br>* Sitting for 50 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 24 hour glucose levels (mmol/l) | Mean glucose assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean amplitude of glycemic excursions (MAGE) | MAGE assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring | 24 hours | 
| Standard Deviation of Glucose Values | Standard deviation of glucose values assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring | 24 hours | 
| Post-dinner glucose control | Incremental area under the glucose curve for 2 hours following dinner | 2 hours following dinner | 
| Post-lunch glucose control | Incremental area under the glucose curve for 2 hours following lunch | 2 hours following lunch | 
| Post-breakfast glucose control | Incremental area under the glucose curve for 2 hours following breakfast | 2 hour following breakfast | 
| Time spent above 10 mmol/l glucose | Time in minutes above 10 mmol/l assessed by continuous glucose monitoring over 24 hours | 24 hours following walking or seated control |