PreDiabetesINTENSITYNCT03787836
Improving Individual Glycemic Response With Exercise Intensity
A study testing Maintained Exercise and Increased Intensity in people with PreDiabetes and Diabetes Mellitus, Type 2, run by University of New Brunswick at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- PreDiabetes, Diabetes Mellitus, Type 2, Exercise
- What is being tested?
- Maintained Exercise and Increased Intensity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2019to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2, Exercise, Physical Activity
- Being tested
- Maintained Exercise, Increased Intensity
- Keywords
- Exercise Response, Interindividual Variability
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintained ExerciseBehavioural
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 IntensityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Controls | No intervention | 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. |
| Exercisers (Maintained) | Experimental | 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. Receives: Behavioral: Maintained Exercise |
| Exercisers (Increased Intensity) | Experimental | 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. Receives: Behavioral: Increased Intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise responders following initial program
The number of responders to the original 16-week exercise program, based on improvement in glycated hemoglobin
Measured: 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
Measured: Week 30
Secondary outcomes (13)
Sex
Participant self-reported biological sex
Measured: Baseline
Family history of cardiovascular disease
Self-reported family history of cardiovascular disease
Measured: Baseline
Family history of cardiometabolic disease
Self-reported family history of cardiometabolic disease
Measured: Baseline
Current medication use
Record of quantity and dose of current medications
Measured: Baseline
Physical activity patterns
Participant self-reported physical activity patterns and daily step counts over a 7-day period.
Measured: Baseline
Daily step count
Daily step count as recorded over a 7-day period
Measured: Baseline
Body mass
Body mass (kilograms)
Measured: Baseline, week 17 and week 30
Height
Height (centimetres)
Measured: Baseline, week 17 and week 30
Waist circumference
Waist circumference (cm)
Measured: Baseline, week 17 and week 30
Fat mass
Fat mass (kg)
Measured: Baseline, week 17 and week 30
Fat free mass
Fat free mass (kg)
Measured: Baseline, week 17 and week 30
Cardiorespiratory fitness
VO2 peak
Measured: 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
Measured: Baseline, week 17, week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 May 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, New Brunswick Health Research Foundation
- Responsible party
- Principal investigator, Martin Senechal, University of New Brunswick
- Investigators
- Martin Senechal, PhD, Principal investigator, University of New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787836
- Sponsor's protocol ID
- 2018-168
- Acronym
- INTENSITY
- Status last verified
- May 2022
- First submitted
- 21 Dec 2018
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29357481Montero 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.
PubMed 28133739de 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.
PubMed 28493912Thomson A, Paudel Y, Rioux B, Hrubeniuk T, Senechal M. Type 2 diabetes duration and irisin response after an aerobic exercise intervention: results from the INTENSITY study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-11. doi: 10.1139/apnm-2024-0533.
PubMed 40456183Thomson AM, Rioux BV, Hrubeniuk TJ, Bouchard DR, Senechal M. Does type 2 diabetes duration influence the effectiveness of an aerobic exercise intervention: Results from the INTENSITY study. PLoS One. 2024 Jun 6;19(6):e0304341. doi: 10.1371/journal.pone.0304341. eCollection 2024.
PubMed 38843234Hrubeniuk 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.
PubMed 33820788
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Individual Glycemic Response With Exercise Intensity
- ClinicalTrials.gov ID
- NCT03787836
- Acronym / sponsor ID
- INTENSITY / 2018-168
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2, Exercise, Physical Activity
- Keywords
- Exercise Response, Interindividual Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, New Brunswick Health Research Foundation
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Controls | No intervention | –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. |
| Exercisers (Maintained) | Experimental | Behavioral: 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) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maintained ExerciseComplete 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. | Behavioural | Exercisers (Maintained) |
| Increased IntensityComplete 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. | Behavioural | Exercisers (Increased Intensity) |
Primary outcome
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
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
13 secondary outcomes
Sex
Time frame: Baseline
Family history of cardiovascular disease
Time frame: Baseline
Family history of cardiometabolic disease
Time frame: Baseline
Current medication use
Time frame: Baseline
Physical activity patterns
Time frame: Baseline
Daily step count
Time frame: Baseline
Body mass
Time frame: Baseline, week 17 and week 30
Height
Time frame: Baseline, week 17 and week 30
Waist circumference
Time frame: Baseline, week 17 and week 30
Fat mass
Time frame: Baseline, week 17 and week 30
Fat free mass
Time frame: Baseline, week 17 and week 30
Cardiorespiratory fitness
Time frame: Baseline, week 17 and week 30
Body mass index
Time frame: Baseline, week 17, week 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Background: PubMed 29357481Hecksteden 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.
- Background: PubMed 28133739Montero 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.
- Background: PubMed 28493912de 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.
- Derived from this study: PubMed 40456183Thomson A, Paudel Y, Rioux B, Hrubeniuk T, Senechal M. Type 2 diabetes duration and irisin response after an aerobic exercise intervention: results from the INTENSITY study. Appl Physiol Nutr Metab. 2025 Jan 1;50:1-11. doi: 10.1139/apnm-2024-0533.
- Derived from this study: PubMed 38843234Thomson AM, Rioux BV, Hrubeniuk TJ, Bouchard DR, Senechal M. Does type 2 diabetes duration influence the effectiveness of an aerobic exercise intervention: Results from the INTENSITY study. PLoS One. 2024 Jun 6;19(6):e0304341. doi: 10.1371/journal.pone.0304341. eCollection 2024.
- Derived from this study: PubMed 33820788Hrubeniuk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Senechal, PhD principal investigator
University of New Brunswick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maintained Exercise and Increased Intensity in people with PreDiabetes and Diabetes Mellitus, Type 2, run by University of New Brunswick at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise responders following initial program (time frame: Week 17). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03787836, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.