Improving Individual Glycemic Response With Exercise Intensity

Improving Individual Glycemic Response With Exercise Intensity

Sponsors

Lead sponsor: University of New Brunswick

Collaborator: Heart and Stroke Foundation of Canada
New Brunswick Health Research Foundation

Source University of New Brunswick
Brief Summary

Large interindividual variability exists in the glycemic response to exercise program, resulting in a subset of individuals known as exercise non-responders (NRs). Increasing the intensity of an exercise intervention has been proposed as one method for improving the response rate and reducing the proportion of NRs. However, this theory has not been tested on NRs classified using glycemic outcomes. This study will evaluate if increasing the intensity of an exercise intervention will elicit a response within previous exercise NRs.

Detailed Description

Exercise can effectively slow the progression towards Type 2 diabetes (T2D). However, data suggest large interindividual variability exists in glycemic response to exercise, resulting in a subset of individuals known as exercise non-responders (NRs). Emerging research proposes that altering the parameters of an exercise intervention to provide a sufficient stimulus can elicit an improved response rate, thus blunting the exercise NRs phenotype. To date, no research has attempted to reduce the proportion of exercise NRs based on glycemic outcomes by altering the parameters of an exercise intervention.

This study will implement an exercise program targeted at achieving the Canadian Physical Activity Guidelines, and calculate the proportion of NRs. We will then evaluate if increasing the intensity of exercise will elicit response to the treatment in the NRs.

Sixty adults living with prediabetes or T2D will be recruited into one of a control group, or an exercise group. The exercising participants will begin a 16-week exercise intervention, targeted at achieving 150 minutes of moderate to vigorous intensity (equating to 4.5 METs) aerobic physical activity per week. Following the 16-week exercise program, participants will be randomized into two groups, each completing an additional 12 weeks of exercise. The first will maintain the same time and intensity, while the other will complete the 150 minutes per week at an intensity equal to 6.0 METs. Randomization will occur in blocks in order to ensure an equal number of NRs in each group.

Overall Status Recruiting
Start Date May 1, 2019
Completion Date August 29, 2021
Primary Completion Date August 29, 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Exercise responders following initial program Week 17
Exercise responders following initial program Week 17
Exercise responders following initial program Week 17
Exercise responders following additional exercise program Week 30
Exercise responders following additional exercise program Week 30
Exercise responders following additional exercise program Week 30
Enrollment 60
Condition
Intervention

Intervention type: Behavioral

Intervention name: Maintained Exercise

Description: Complete 28 weeks of aerobic exercise, with one week (following week 16) for testing. Week 1 - 16 Intensity: 4.5 metabolic equivalents (METs). Duration: Week 1: 80 minutes Week 2: 100 minutes Week 3: 120 minutes Week 4: 135 minutes Week 5 - 16: 150 minutes/week Week 17: Physiological Testing Week 18 - 29 Intensity: 4.5 METs Duration: 150 minutes/week All exercise must be completed across a minimum of two sessions per week. Sub-maximal exercise tests will be completed every 4 weeks to adjust intensity.

Arm group label: Exercisers (Maintained)

Intervention type: Behavioral

Intervention name: Increased Intensity

Description: Complete 28 weeks of aerobic exercise, with one week (following week 16) for testing. Week 1 - 16 Intensity: 4.5 metabolic equivalents (METs). Duration: Week 1: 80 minutes Week 2: 100 minutes Week 3: 120 minutes Week 4: 135 minutes Week 5 - 16: 150 minutes/week Week 17: Physiological Testing Week 18 - 29 Intensity: 6.0 METs Duration: 150 minutes/week All exercise must be completed across a minimum of two sessions per week. Sub-maximal exercise tests will be completed every 4 weeks to adjust intensity.

Arm group label: Exercisers (Increased Intensity)

Eligibility

Criteria:

Inclusion Criteria:

- Currently living with prediabetes or Type 2 diabetes

- Adults (age 19 - 65 years)

Exclusion Criteria:

- Currently participating in 150 minutes or more of structured exercise per week

- Chronic disease or injury that would interfere with, or restrict ability to complete, exercise

Gender: All

Minimum age: 19 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Martin Senechal, PhD Principal Investigator University of New Brunswick
Overall Contact

Last name: Martin Senechal, PhD

Phone: (506) 451-6889

Email: [email protected]

Location
facility status contact
University of New Brunswick Recruiting Martin Senechal, PhD
Location Countries

Canada

Verification Date

May 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of New Brunswick

Investigator full name: Martin Senechal

Investigator title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Controls

Arm group type: No Intervention

Description: The primary purpose of the control participants are to provide a measure of variability. They will be used in our calculations of typical error to classify participants as responders or non-responders, and to quantify inter-individual variability.

Arm group label: Exercisers (Maintained)

Arm group type: Experimental

Description: The maintained exercise group will complete the original 16-week exercise intervention at an intensity of 4.5 metabolic equivalents (METs), and repeat the intervention for another 12-weeks following its completion.

Arm group label: Exercisers (Increased Intensity)

Arm group type: Experimental

Description: The increased intensity exercise group will complete the original 16-week exercise intervention, followed by an additional 12 week intervention completed at an intensity of 6.0 METs.

Acronym INTENSITY
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Participants will first be randomized as controls or exercisers. All exercisers will complete a 16 week exercise program, then be randomized into two groups. The first group will increase the exercise intensity and conduct another 12 week program. The second group will continue the original program for an additional 12 weeks.

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov