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Completed

NCT Number: NCT03787836

Improving Individual Glycemic Response With Exercise Intensity

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 rescuing NRs by producing beneficial changes. 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.

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Key information

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Brunswick

Fredericton, New Brunswick, E3B 5A3, Canada

About this study

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 a response in those previously identified as NRs. To date, no research has attempted to rescue previously classified 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 number 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Community-dwelling adults aged 19 years or older.
  • Currently living with prediabetes or T2DM as diagnosed by a physician and confirmed by an HbA1c value of 5.7% or above, as verified by duplicate testing.
  • Not currently partaking in a self-reported regular physical activity regimen, defined as consistent participation in running or jogging activity, attending physical activity or exercise classes on a weekly basis, or averaging 10,000 steps per day or more over the course of 7 days.

Exclusion criteria

  • Self reported as currently diagnosed as having, or being treated for, low iron concentrations or anemia.
  • Diagnosed with any red blood cell altering condition.
  • Currently living with any cardiovascular disease which would impact the ability to safely participate in exercise training.
  • Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track exercise intensity.

Treatment and study plan

Maintained Exercise

Behavioral

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.

Increased Intensity

Behavioral

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 outcomes

  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

Secondary outcomes

  1. Sex

    Time frame: Baseline

    Participant self-reported biological sex

  2. Family history of cardiovascular disease

    Time frame: Baseline

    Self-reported family history of cardiovascular disease

  3. Family history of cardiometabolic disease

    Time frame: Baseline

    Self-reported family history of cardiometabolic disease

  4. Current medication use

    Time frame: Baseline

    Record of quantity and dose of current medications

  5. Physical activity patterns

    Time frame: Baseline

    Participant self-reported physical activity patterns and daily step counts over a 7-day period.

  6. Daily step count

    Time frame: Baseline

    Daily step count as recorded over a 7-day period

  7. Body mass

    Time frame: Baseline, week 17 and week 30

    Body mass (kilograms)

  8. Height

    Time frame: Baseline, week 17 and week 30

    Height (centimetres)

  9. Waist circumference

    Time frame: Baseline, week 17 and week 30

    Waist circumference (cm)

  10. Fat mass

    Time frame: Baseline, week 17 and week 30

    Fat mass (kg)

  11. Fat free mass

    Time frame: Baseline, week 17 and week 30

    Fat free mass (kg)

  12. Cardiorespiratory fitness

    Time frame: Baseline, week 17 and week 30

    VO2 peak

  13. Body mass index

    Time frame: Baseline, week 17, week 30

    Weight (kilograms) and height (measured in centimetres and converted to metres) will be combined to report body mass index in kg/m^2

Sponsors and collaborators

Lead sponsor

University of New Brunswick

Other

Collaborators

  • Heart and Stroke Foundation of Canada
  • New Brunswick Health Research Foundation

Registry information

Acronym: INTENSITY

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 26, 2018
Registry last updated
May 18, 2022

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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