Improving Individual Glycemic Response With Exercise Intensity

Diabetes Mellitus, Type 2 Clinical Trial

— INTENSITY  

Official title:

Improving Individual Glycemic Response With Exercise Intensity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03787836
• Other study ID #: 2018-168
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: May 2022
• Source: University of New Brunswick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Exercise
• Physical Activity
• PreDiabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	University of New Brunswick	Fredericton	New Brunswick

Sponsors (3)

Lead Sponsor	Collaborator
University of New Brunswick	Heart and Stroke Foundation of Canada, New Brunswick Health Research Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise responders following initial program	The number of responders to the original 16-week exercise program, based on improvement in glycated hemoglobin	Week 17
Primary	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	Sex	Participant self-reported biological sex	Baseline
Secondary	Family history of cardiovascular disease	Self-reported family history of cardiovascular disease	Baseline
Secondary	Family history of cardiometabolic disease	Self-reported family history of cardiometabolic disease	Baseline
Secondary	Current medication use	Record of quantity and dose of current medications	Baseline
Secondary	Physical activity patterns	Participant self-reported physical activity patterns and daily step counts over a 7-day period.	Baseline
Secondary	Daily step count	Daily step count as recorded over a 7-day period	Baseline
Secondary	Body mass	Body mass (kilograms)	Baseline, week 17 and week 30
Secondary	Height	Height (centimetres)	Baseline, week 17 and week 30
Secondary	Waist circumference	Waist circumference (cm)	Baseline, week 17 and week 30
Secondary	Fat mass	Fat mass (kg)	Baseline, week 17 and week 30
Secondary	Fat free mass	Fat free mass (kg)	Baseline, week 17 and week 30
Secondary	Cardiorespiratory fitness	VO2 peak	Baseline, week 17 and week 30
Secondary	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