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Completed

NCT Number: NCT02834689

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

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.

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Key information

Conditions

Walking Seated Control

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking

Behavioral

Walking on a treadmill at 3.5 METS for 50 minutes

Seated Control

Behavioral

Sitting for 50 minutes

Primary outcomes

  1. Mean 24 hour glucose levels (mmol/l)

    Time frame: 24 hours

    Mean glucose assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring

Secondary outcomes

  1. Mean amplitude of glycemic excursions (MAGE)

    Time frame: 24 hours

    MAGE assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring

  2. Standard Deviation of Glucose Values

    Time frame: 24 hours

    Standard deviation of glucose values assessed for 24 hours after walking or seated control assessed by continuous glucose monitoring

  3. Post-dinner glucose control

    Time frame: 2 hours following dinner

    Incremental area under the glucose curve for 2 hours following dinner

  4. Post-lunch glucose control

    Time frame: 2 hours following lunch

    Incremental area under the glucose curve for 2 hours following lunch

  5. Post-breakfast glucose control

    Time frame: 2 hour following breakfast

    Incremental area under the glucose curve for 2 hours following breakfast

  6. Time spent above 10 mmol/l glucose

    Time frame: 24 hours following walking or seated control

    Time in minutes above 10 mmol/l assessed by continuous glucose monitoring over 24 hours

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Centre de Recheche du Centre Hospitalier Université Laval
  • Children's Hospital Research Institute of Manitoba
  • McMaster University
  • Medtronic
  • University of Alberta
  • University of Calgary
  • Université de Sherbrooke

Registry information

Acronym: E-PAraDiGM

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2016
Registry last updated
Oct 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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