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

Walking Clinical Trial

— E-PAraDiGM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834689
• Other study ID #: H1600377
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: October 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Seated Control
• Walking

Intervention

Behavioral:
• Walking
Walking on a treadmill at 3.5 METS for 50 minutes
• Seated Control
Sitting for 50 minutes

Locations

Country	Name	City	State
Canada	University of British Columbia, Okanagan.	Kelowna	British Columbia

Sponsors (8)

Lead Sponsor	Collaborator
University of British Columbia	Centre Hospitalier de l'Université Laval, Children's Hospital Research Institute of Manitoba, McMaster University, Medtronic, Université de Sherbrooke, University of Alberta, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean amplitude of glycemic excursions (MAGE)	MAGE assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring	24 hours
Secondary	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
Secondary	Post-dinner glucose control	Incremental area under the glucose curve for 2 hours following dinner	2 hours following dinner
Secondary	Post-lunch glucose control	Incremental area under the glucose curve for 2 hours following lunch	2 hours following lunch
Secondary	Post-breakfast glucose control	Incremental area under the glucose curve for 2 hours following breakfast	2 hour following breakfast
Secondary	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