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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02834689
Acronym
E-PAraDiGM
Enrollment
79
Registered
2016-07-15
Start date
2016-07-01
Completion date
2017-12-01
Last updated
2019-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seated Control, Walking

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.

Interventions

BEHAVIORALWalking

Walking on a treadmill at 3.5 METS for 50 minutes

BEHAVIORALSeated Control

Sitting for 50 minutes

Sponsors

University of Alberta
CollaboratorOTHER
University of Calgary
CollaboratorOTHER
McMaster University
CollaboratorOTHER
Université de Sherbrooke
CollaboratorOTHER
Centre Hospitalier de l'Université Laval
CollaboratorUNKNOWN
Children's Hospital Research Institute of Manitoba
CollaboratorOTHER
Medtronic
CollaboratorINDUSTRY
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Mean 24 hour glucose levels (mmol/l)24 hoursMean glucose assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring

Secondary

MeasureTime frameDescription
Standard Deviation of Glucose Values24 hoursStandard deviation of glucose values assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring
Post-dinner glucose control2 hours following dinnerIncremental area under the glucose curve for 2 hours following dinner
Mean amplitude of glycemic excursions (MAGE)24 hoursMAGE assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring
Post-breakfast glucose control2 hour following breakfastIncremental area under the glucose curve for 2 hours following breakfast
Time spent above 10 mmol/l glucose24 hours following walking or seated controlTime in minutes above 10 mmol/l assessed by continuous glucose monitoring over 24 hours
Post-lunch glucose control2 hours following lunchIncremental area under the glucose curve for 2 hours following lunch

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026