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

NCT ID: NCT02834689

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Walking Seated Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Walking

Walking on a treadmill at 3.5 metabolic equivalents (METS) for 50 minutes

Group Type EXPERIMENTAL

Walking

Intervention Type BEHAVIORAL

Walking on a treadmill at 3.5 METS for 50 minutes

Seated Control

Sitting for 50 minutes

Group Type EXPERIMENTAL

Seated Control

Intervention Type BEHAVIORAL

Sitting for 50 minutes

Interventions

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Walking

Walking on a treadmill at 3.5 METS for 50 minutes

Intervention Type BEHAVIORAL

Seated Control

Sitting for 50 minutes

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role collaborator

Centre Hospitalier de l'Université Laval

UNKNOWN

Sponsor Role collaborator

Children's Hospital Research Institute of Manitoba

OTHER

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Little

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of British Columbia, Okanagan.

Kelowna, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 31093764 (View on PubMed)

Other Identifiers

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H1600377

Identifier Type: -

Identifier Source: org_study_id

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