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Improving Individual Glycemic Response With Exercise Intensity (INTENSITY)

Primary Purpose

PreDiabetes, Diabetes Mellitus, Type 2, Exercise

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Maintained Exercise
Increased Intensity
Sponsored by
University of New Brunswick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring Exercise Response, Interindividual Variability

Eligibility Criteria

19 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of New Brunswick

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Controls

Exercisers (Maintained)

Exercisers (Increased Intensity)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Exercise responders following initial program
The number of responders to the original 16-week exercise program, based on improvement in glycated hemoglobin
Exercise responders following additional exercise program
The number of responders following the additional 12-week exercise program, based on improvement in glycated hemoglobin

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2018
Last Updated
May 16, 2022
Sponsor
University of New Brunswick
Collaborators
Heart and Stroke Foundation of Canada, New Brunswick Health Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03787836
Brief Title
Improving Individual Glycemic Response With Exercise Intensity
Acronym
INTENSITY
Official Title
Improving Individual Glycemic Response With Exercise Intensity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of New Brunswick
Collaborators
Heart and Stroke Foundation of Canada, New Brunswick Health Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes, Diabetes Mellitus, Type 2, Exercise, Physical Activity
Keywords
Exercise Response, Interindividual Variability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controls
Arm Type
No Intervention
Arm Description
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.
Arm Title
Exercisers (Maintained)
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercisers (Increased Intensity)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Maintained Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Increased Intensity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise responders following initial program
Description
The number of responders to the original 16-week exercise program, based on improvement in glycated hemoglobin
Time Frame
Week 17
Title
Exercise responders following additional exercise program
Description
The number of responders following the additional 12-week exercise program, based on improvement in glycated hemoglobin
Time Frame
Week 30
Secondary Outcome Measure Information:
Title
Sex
Description
Participant self-reported biological sex
Time Frame
Baseline
Title
Family history of cardiovascular disease
Description
Self-reported family history of cardiovascular disease
Time Frame
Baseline
Title
Family history of cardiometabolic disease
Description
Self-reported family history of cardiometabolic disease
Time Frame
Baseline
Title
Current medication use
Description
Record of quantity and dose of current medications
Time Frame
Baseline
Title
Physical activity patterns
Description
Participant self-reported physical activity patterns and daily step counts over a 7-day period.
Time Frame
Baseline
Title
Daily step count
Description
Daily step count as recorded over a 7-day period
Time Frame
Baseline
Title
Body mass
Description
Body mass (kilograms)
Time Frame
Baseline, week 17 and week 30
Title
Height
Description
Height (centimetres)
Time Frame
Baseline, week 17 and week 30
Title
Waist circumference
Description
Waist circumference (cm)
Time Frame
Baseline, week 17 and week 30
Title
Fat mass
Description
Fat mass (kg)
Time Frame
Baseline, week 17 and week 30
Title
Fat free mass
Description
Fat free mass (kg)
Time Frame
Baseline, week 17 and week 30
Title
Cardiorespiratory fitness
Description
VO2 peak
Time Frame
Baseline, week 17 and week 30
Title
Body mass index
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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. Exclusion criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Senechal, PhD
Organizational Affiliation
University of New Brunswick
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Brunswick
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 5A3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29357481
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.
Results Reference
background
PubMed Identifier
28133739
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. Erratum In: J Physiol. 2018 Apr 1;596(7):1311.
Results Reference
background
PubMed Identifier
28493912
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.
Results Reference
background
PubMed Identifier
33820788
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.
Results Reference
derived

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Improving Individual Glycemic Response With Exercise Intensity

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