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

Not Applicable

Completed

• Conditions: Seated Control; Walking
• Interventions: Behavioral: Seated Control; Behavioral: Walking

• Registration Number: NCT02834689
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-15
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Seated Control	Seated Control	Sitting for 50 minutes
Walking	Walking	Walking on a treadmill at 3.5 metabolic equivalents (METS) for 50 minutes

Primary Outcome Measures

Name	Time	Method
Mean 24 hour glucose levels (mmol/l)	24 hours	Mean glucose assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of British Columbia, Okanagan.; 🇨🇦 Kelowna, British Columbia, Canada