An interventional study of Maintained Exercise and Increased Intensity in PreDiabetes, Diabetes Mellitus, Type 2 and Exercise, sponsored by University of New Brunswick. Completed at 1 site in Canada. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University of New Brunswick · Not applicable, Interventional, and Prevention
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 61 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of New Brunswick is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
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Exclusion criteria:
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.
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
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: 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.
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.
Exercise responders following initial program
The number of responders to the original 16-week exercise program, based on improvement in glycated hemoglobin
Time frame: Week 17
Exercise responders following additional exercise program
The number of responders following the additional 12-week exercise program, based on improvement in glycated hemoglobin
Time frame: Week 30
Sex
Participant self-reported biological sex
Time frame: Baseline
Family history of cardiovascular disease
Self-reported family history of cardiovascular disease
Time frame: Baseline
Family history of cardiometabolic disease
Self-reported family history of cardiometabolic disease
Time frame: Baseline
Current medication use
Record of quantity and dose of current medications
Time frame: Baseline
Physical activity patterns
Participant self-reported physical activity patterns and daily step counts over a 7-day period.
Time frame: Baseline
Daily step count
Daily step count as recorded over a 7-day period
Time frame: Baseline
Body mass
Body mass (kilograms)
Time frame: Baseline, week 17 and week 30
Height
Height (centimetres)
Time frame: Baseline, week 17 and week 30
Waist circumference
Waist circumference (cm)
Time frame: Baseline, week 17 and week 30
Fat mass
Fat mass (kg)
Time frame: Baseline, week 17 and week 30
Fat free mass
Fat free mass (kg)
Time frame: Baseline, week 17 and week 30
Cardiorespiratory fitness
VO2 peak
Time frame: Baseline, week 17 and week 30
Body mass index
Weight (kilograms) and height (measured in centimetres and converted to metres) will be combined to report body mass index in kg/m\^2
Time frame: Baseline, week 17, week 30
Plan to share: No
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of New Brunswick