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

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.

Study Overview

• Status: Completed
• Conditions: Walking; Seated Control
• Intervention / Treatment: Behavioral: Walking; Behavioral: Seated Control

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1V 1V7
      • University of British Columbia, Okanagan.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walking; Walking on a treadmill at 3.5 metabolic equivalents (METS) for 50 minutes	Behavioral: Walking; Walking on a treadmill at 3.5 METS for 50 minutes
Experimental: Seated Control; Sitting for 50 minutes	Behavioral: Seated Control; Sitting for 50 minutes

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Université de Sherbrooke; University of Alberta; McMaster University; University of Calgary; Medtronic; Children's Hospital Research Institute of Manitoba; Centre Hospitalier de l'Université Laval

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 15, 2016

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: H1600377