NCT03626155

Brief Summary

It is not clear if there is an optimal time for exercise to improve blood glucose profiles in people with type 2 diabetes. The goal of this study is to compare post meal and 24-hour glucose levels in 4 different conditions: i-seated control, ii-fasted state exercise, iii-30 minutes post meal exercise, and iv- 3-4-hour post meal exercise. The primary outcome of this study is glucose control assessed over 24 hours using continuous glucose monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable type-2-diabetes-mellitus

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

June 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

July 9, 2018

Last Update Submit

September 24, 2019

Conditions

Keywords

Walkingtype 2 diabetescontinuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

  • Mean 24-hour glucose

    Glucose measured by continuous glucose monitoring over 24 hours starting at the beginning of exercise on seated control

    Within the 24 hours following exercise or control

Secondary Outcomes (5)

  • Postprandial glucose

    Within the 24 hours following exercise or control

  • Glucose variability

    Within the 24 hours following exercise or control

  • Fasting glucose

    Within the 24 hours following exercise or control

  • Energy expenditure (METs)

    Within the 50 minutes of exercise or control

  • Respiratory Exchange Ratio (RER)

    Within the 50 minutes of exercise or control

Study Arms (4)

Seated Control

EXPERIMENTAL
Behavioral: Seated Control

Morning Exercise (walking)

EXPERIMENTAL
Behavioral: Walking

Afternoon Exercise (walking)

EXPERIMENTAL
Behavioral: Walking

Evening Exercise (walking)

EXPERIMENTAL
Behavioral: Walking

Interventions

WalkingBEHAVIORAL

Walking will last 50 minutes and will be at 5.0 km/h and at 0.5% incline

Afternoon Exercise (walking)Evening Exercise (walking)Morning Exercise (walking)
Seated ControlBEHAVIORAL

Participants will be asked to sit quietly and read during a 50 minute control period

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
  • Able to understand English or French and comply with study requirements (e.g., attend visits during the day)

You may not qualify if:

  • Contraindications to exercise (PAR-Q+, Rose Angina questionnaire, limited ability to walk for 50 min).
  • Allergies or dietary restriction that could prevent adherence to standardize meals.
  • Previous myocardial infarction, stroke or diagnosed coronary artery disease
  • Changes in diabetes medication in last 3 months
  • Treated by insulin or corticosteroids
  • Change in body weight (\>5%) in last 3 months
  • Blood pressure \>160/100 mmHg; resting heart rate\>100

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Walking

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Normand Boule, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 9, 2018

First Posted

August 10, 2018

Study Start

June 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations