Clinical trial NCT02834689: The Canadian E-PAraDiGM (Exercise Physical Activity and Diabetes Glucose Monitoring) Protocol
Official title: The Canadian E-PAraDiGM (Exercise Physical Activity and Diabetes Glucose Monitoring) Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Walking
Seated Control
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: University of Calgary
name: McMaster University
name: Université de Sherbrooke
name: Centre Hospitalier de l'Université Laval
name: Children's Hospital Research Institute of Manitoba
name: Medtronic
First posted: 2016-07-15
Enrollment: 79
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean 24 hour glucose levels (mmol/l)
timeFrame: 24 hours
Secondary outcomes:
measure: Mean amplitude of glycemic excursions (MAGE)
timeFrame: 24 hours
measure: Standard Deviation of Glucose Values
timeFrame: 24 hours
measure: Post-dinner glucose control
timeFrame: 2 hours following dinner
measure: Post-lunch glucose control
timeFrame: 2 hours following lunch
measure: Post-breakfast glucose control
timeFrame: 2 hour following breakfast
measure: Time spent above 10 mmol/l glucose
timeFrame: 24 hours following walking or seated control
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia, Okanagan.
state: British Columbia
Study officials:
References:
citation: Rees JL, Chang CR, Francois ME, Marcotte-Chenard A, Fontvieille A, Klaprat ND, Dyck RA, Funk DR, Snydmiller G, Bastell K, Godkin FE, Dube MC, Riesco E, McGavock JM, Yardley JE, Sigal RJ, Gibala MJ, Weisnagel SJ, Prado CM, Jung M, Manders R, Lee T, Singer J, Boule NG, Little JP. Minimal effect of walking before dinner on glycemic responses in type 2 diabetes: outcomes from the multi-site E-PAraDiGM study. Acta Diabetol. 2019 Jul;56(7):755-765. doi: 10.1007/s00592-019-01358-x. Epub 2019 May 15.