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Improving Individual Glycemic Response With Exercise Intensity (INTENSITY)

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ClinicalTrials.gov Identifier: NCT03787836
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : May 20, 2019
Sponsor:
Collaborators:
Heart and Stroke Foundation of Canada
New Brunswick Health Research Foundation
Information provided by (Responsible Party):
Martin Senechal, 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.

Condition or disease Intervention/treatment Phase
PreDiabetes Diabetes Mellitus, Type 2 Exercise Physical Activity Behavioral: Maintained Exercise Behavioral: Increased Intensity Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Individual Glycemic Response With Exercise Intensity
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : August 29, 2021
Estimated Study Completion Date : August 29, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Controls
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.
Experimental: Exercisers (Maintained)
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.
Behavioral: Maintained Exercise

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.


Experimental: Exercisers (Increased Intensity)
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.
Behavioral: Increased Intensity

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.





Primary Outcome Measures :
  1. Exercise responders following initial program [ Time Frame: Week 17 ]
    The number of responders to the original 16-week exercise program, based on improvement in glycated hemoglobin

  2. Exercise responders following additional exercise program [ Time Frame: Week 30 ]
    The number of responders following the additional 12-week exercise program, based on improvement in glycated hemoglobin



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787836


Contacts
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Contact: Martin Senechal, PhD (506) 451-6889 martin.senechal@unb.ca
Contact: Travis J Hrubeniuk (204) 290-0331 travis.hrubeniuk@unb.ca

Locations
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Canada, New Brunswick
University of New Brunswick Recruiting
Fredericton, New Brunswick, Canada, E3B 5A3
Contact: Martin Senechal, PhD         
Sponsors and Collaborators
University of New Brunswick
Heart and Stroke Foundation of Canada
New Brunswick Health Research Foundation
Investigators
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Principal Investigator: Martin Senechal, PhD University of New Brunswick

Publications:
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Responsible Party: Martin Senechal, Assistant Professor, University of New Brunswick
ClinicalTrials.gov Identifier: NCT03787836     History of Changes
Other Study ID Numbers: 2018-168
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Martin Senechal, University of New Brunswick:
Exercise Response
Interindividual Variability

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases