Walking Clinical Trial
— E-PAraDiGMOfficial title:
The Canadian E-PAraDiGM (Exercise Physical Activity and Diabetes Glucose Monitoring) Protocol
NCT number | NCT02834689 |
Other study ID # | H1600377 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2016 |
Est. completion date | December 1, 2017 |
Verified date | October 2019 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia, Okanagan. | Kelowna | British Columbia |
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 |
Canada,
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 |
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