NCT02834689

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

1.4 years

First QC Date

July 13, 2016

Last Update Submit

October 2, 2019

Conditions

WalkingSeated Control

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Mean amplitude of glycemic excursions (MAGE)

    24 hours

  • Standard Deviation of Glucose Values

    24 hours

  • Post-dinner glucose control

    2 hours following dinner

  • Post-lunch glucose control

    2 hours following lunch

  • Post-breakfast glucose control

    2 hour following breakfast

  • +1 more secondary outcomes

Study Arms (2)

Walking

EXPERIMENTAL

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

Behavioral: Walking

Seated Control

EXPERIMENTAL

Sitting for 50 minutes

Behavioral: Seated Control

Interventions

WalkingBEHAVIORAL

Walking on a treadmill at 3.5 METS for 50 minutes

Walking
Seated ControlBEHAVIORAL

Sitting for 50 minutes

Seated Control

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with T2D for more than 6 months
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

Location

Related Publications (1)

  • 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.

    PMID: 31093764DERIVED

MeSH Terms

Interventions

Walking

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 15, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

October 3, 2019

Record last verified: 2019-10

Locations

CA(1)