Improving Individual Glycemic Response With Exercise Intensity (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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Physical Activity; PreDiabetes; Exercise
• Intervention / Treatment: Behavioral: Maintained Exercise; Behavioral: Increased Intensity

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 5A3
      • University of New Brunswick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise responders following initial program	The number of responders to the original 16-week exercise program, based on improvement in glycated hemoglobin	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	Week 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex	Participant self-reported biological sex	Baseline
Family history of cardiovascular disease	Self-reported family history of cardiovascular disease	Baseline
Family history of cardiometabolic disease	Self-reported family history of cardiometabolic disease	Baseline
Current medication use	Record of quantity and dose of current medications	Baseline
Physical activity patterns	Participant self-reported physical activity patterns and daily step counts over a 7-day period.	Baseline
Daily step count	Daily step count as recorded over a 7-day period	Baseline
Body mass	Body mass (kilograms)	Baseline, week 17 and week 30
Height	Height (centimetres)	Baseline, week 17 and week 30
Waist circumference	Waist circumference (cm)	Baseline, week 17 and week 30
Fat mass	Fat mass (kg)	Baseline, week 17 and week 30
Fat free mass	Fat free mass (kg)	Baseline, week 17 and week 30
Cardiorespiratory fitness	VO2 peak	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	Baseline, week 17, week 30

Collaborators and Investigators

• Sponsor: University of New Brunswick
• Collaborators: Heart and Stroke Foundation of Canada; New Brunswick Health Research Foundation

Publications and helpful links

General Publications

• 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. Erratum In: J Physiol. 2018 Apr 1;596(7):1311.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 26, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Exercise Response; Interindividual Variability
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2018-168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No