Clinical trial NCT03787836: Improving Individual Glycemic Response With Exercise Intensity
Official title: Improving Individual Glycemic Response With Exercise Intensity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Diabetes Mellitus, Type 2
Exercise
Physical Activity
Keywords: Exercise Response
Interindividual Variability
Lead sponsor: University of New Brunswick
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
name: New Brunswick Health Research Foundation
First posted: 2018-12-26
Enrollment: 61
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

Eligibility criteria: Inclusion criteria:

1. Community-dwelling adults aged 19 years or older.
2. 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.
3. 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:

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

Primary outcomes:
measure: Exercise responders following initial program
timeFrame: Week 17
measure: Exercise responders following additional exercise program
timeFrame: Week 30
Secondary outcomes:
measure: Sex
timeFrame: Baseline
measure: Family history of cardiovascular disease
timeFrame: Baseline
measure: Family history of cardiometabolic disease
timeFrame: Baseline
measure: Current medication use
timeFrame: Baseline
measure: Physical activity patterns
timeFrame: Baseline
measure: Daily step count
timeFrame: Baseline
measure: Body mass
timeFrame: Baseline, week 17 and week 30
measure: Height
timeFrame: Baseline, week 17 and week 30
measure: Waist circumference
timeFrame: Baseline, week 17 and week 30
measure: Fat mass
timeFrame: Baseline, week 17 and week 30
measure: Fat free mass
timeFrame: Baseline, week 17 and week 30
measure: Cardiorespiratory fitness
timeFrame: Baseline, week 17 and week 30
measure: Body mass index
timeFrame: Baseline, week 17, week 30
Other outcomes:
Locations:
city: Fredericton
country: Canada
facility: University of New Brunswick
state: New Brunswick
Study officials:
affiliation: University of New Brunswick
name: Martin Senechal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hecksteden A, Pitsch W, Rosenberger F, Meyer T. Repeated testing for the assessment of individual response to exercise training. J Appl Physiol (1985). 2018 Jun 1;124(6):1567-1579. doi: 10.1152/japplphysiol.00896.2017. Epub 2018 Jan 11.
citation: Montero D, Lundby C. Refuting the myth of non-response to exercise training: 'non-responders' do respond to higher dose of training. J Physiol. 2017 Jun 1;595(11):3377-3387. doi: 10.1113/JP273480. Epub 2017 May 14.
citation: de Lannoy L, Clarke J, Stotz PJ, Ross R. Effects of intensity and amount of exercise on measures of insulin and glucose: Analysis of inter-individual variability. PLoS One. 2017 May 11;12(5):e0177095. doi: 10.1371/journal.pone.0177095. eCollection 2017.
citation: Hrubeniuk TJ, Bouchard DR, Gurd BJ, Senechal M. Can non-responders be 'rescued' by increasing exercise intensity? A quasi-experimental trial of individual responses among humans living with pre-diabetes or type 2 diabetes mellitus in Canada. BMJ Open. 2021 Apr 5;11(4):e044478. doi: 10.1136/bmjopen-2020-044478.