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

University of British Columbia

Status: Completed

Conditions: Seated Control; Walking

Treatments: Behavioral: Walking; Behavioral: Seated Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02834689

H1600377

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

Walking

Experimental group

Description:

Walking on a treadmill at 3.5 metabolic equivalents (METS) for 50 minutes

Treatment:

Behavioral: Walking

Seated Control

Experimental group

Description:

Sitting for 50 minutes

Treatment:

Behavioral: Seated Control