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Improving Individual Glycemic Response With Exercise Intensity

Not Applicable
Completed
Conditions
PreDiabetes
Exercise
Diabetes Mellitus, Type 2
Physical Activity
Interventions
Behavioral: Maintained Exercise
Behavioral: Increased Intensity
Registration Number
NCT03787836
Lead Sponsor
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 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.

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 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
61
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Exercisers (Maintained)Maintained ExerciseThe 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.
Exercisers (Increased Intensity)Increased IntensityThe 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.
Primary Outcome Measures
NameTimeMethod
Exercise responders following additional exercise programWeek 30

The number of responders following the additional 12-week exercise program, based on improvement in glycated hemoglobin

Exercise responders following initial programWeek 17

The number of responders to the original 16-week exercise program, based on improvement in glycated hemoglobin

Secondary Outcome Measures
NameTimeMethod
HeightBaseline, week 17 and week 30

Height (centimetres)

Body massBaseline, week 17 and week 30

Body mass (kilograms)

Current medication useBaseline

Record of quantity and dose of current medications

Family history of cardiovascular diseaseBaseline

Self-reported family history of cardiovascular disease

Daily step countBaseline

Daily step count as recorded over a 7-day period

Family history of cardiometabolic diseaseBaseline

Self-reported family history of cardiometabolic disease

Physical activity patternsBaseline

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

Waist circumferenceBaseline, week 17 and week 30

Waist circumference (cm)

Fat massBaseline, week 17 and week 30

Fat mass (kg)

Fat free massBaseline, week 17 and week 30

Fat free mass (kg)

SexBaseline

Participant self-reported biological sex

Cardiorespiratory fitnessBaseline, week 17 and week 30

VO2 peak

Body mass indexBaseline, 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

Trial Locations

Locations (1)

University of New Brunswick

🇨🇦

Fredericton, New Brunswick, Canada

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