Diabetes Mellitus, Type 2
Conditions
Keywords
Exercise, Glycated hemoglobin, Liver fat, Continuous glucose monitoring
Brief summary
This study compares aerobic exercise training performed before breakfast (i.e., in the fasted state) to similar training performed after breakfast in people with type 2 diabetes. Training will take place over 16 weeks.
Detailed description
People with type 2 diabetes (T2D) are encouraged to increase their physical activity (PA). Sometimes, increasing the amount of PA can be difficult. Therefore, simply recommending that individuals preform more exercise may not be effective in the long term. Recent short-term studies have started to explore how to maximize the effect of a single bout of exercise. For example, short term studies suggest that exercise performed after a meal may decrease blood sugars more than exercise performed after a meal. However, research in people without diabetes shows this may not be the best approach in the long-term. To date, no long-term study has compared the effects of exercise performed at different times of the day in people with T2D. This study will compare the effects of 16 weeks of regular exercise before breakfast compared to 16 weeks of regular exercise after breakfast. It is expected that exercise before breakfast (i.e., in the fasted state) will lead to greater improvements in blood sugar control, without the addition of more exercise. It could be very motivating for people with diabetes to know that they can get more benefits from exercise by changing when exercise is performed, rather than trying to increase the amount of exercise.
Interventions
BEHAVIORALFasted Exercise
Exercise training will take place 3 times per week and will progress to 60 minutes at a workload corresponding to 80% of Ventilatory Threshold.
BEHAVIORALPostprandial Exercise
Exercise training will take place 3 times per week and will progress to 60 minutes at a workload corresponding to 80% of Ventilatory Threshold.
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
For most outcomes, including the primary outcome, the outcome assessor will be unaware of group allocation.
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Physician diagnosed type 2 diabetes * Treated with diet and/or glucose lowering medications, but not insulin, for at least 6 months * Sedentary (defined as reaching \<150 minutes of aerobic exercise per week) * A1C below 9.0% * BMI ≥25 kg/m2 * Central obesity as determined by waist circumference according to Diabetes Canada cutoffs: * greater or equal to 94cm for males of European, Sub-Saharan African, Eastern Mediterranean and Middle Eastern descent, * greater or equal to 90cm for males of South Asian, Chinese, Japanese, South and Central American descent, * greater or equal to 80cm for females * Able to walk for 50 minutes
Exclusion criteria
* Smoking * Consuming more than 10 alcoholic drinks/week * History of stroke, myocardial infarction, or coronary artery disease * Resting heart rate \<100 bpm * Resting blood pressure \<160/100 mmHg * Implantable device, such as a pacemaker, that would not be safe for Magnetic Resonance Imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of HbA1c (mmol/mol) | Change from baseline HbA1c at 16 weeks | Glycated Hemoglobin |
| Liver fat (%) | Change from baseline liver fat at 16 weeks | Intra-hepatic fat measured by Magnetic Resonance Imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of Fasting glucose | Change from baseline fasting glucose at 16 weeks | Plasma glucose measured after an overnight fast |
| Concentrations of Fasting insulin | Change from baseline fasting insulin at 16 weeks | Plasma insulin measured after an overnight fast |
| Concentrations of Fasting lipids | Change from baseline fasting lipids at 16 weeks | Plasma total cholesterol, HDL-Cholesterol, LDL-Cholesterol and Triglycerides measured after an overnight fast |
| Concentrations of Liver enzymes | Change from baseline liver enzymes at 16 weeks | Alanine aminotransferase, Aspartate aminotransferase measured after an overnight fast |
| Aerobic fitness | Change from baseline aerobic fitness at 16 weeks | Submaximal exercise test to determine ventilatory threshold |
| Pancreatic fat (%) | Change from pancreatic fat at 16 weeks | Pancreatic fat measured by Magnetic Resonance Imaging |
| Waist circumference (centimeters) | Change from baseline waist circumference at 16 weeks | Waist circumference (between 12 rib and iliac crest) measures in centimeters |
| Hip circumference (centimeters) | Change from baseline hip circumference at 16 weeks | Hip circumference (between 12 rib and iliac crest) measures in centimeters |
| Body weight (kilograms) | Change from baseline weight at 16 weeks | Weight will be measured in kilograms |
| Continuous glucose monitoring | Change from the first two to the last two weeks of the 16 week interventions | Continuous glucose monitoring outcomes (e.g., 24-hour mean glucose) |
| Height (centimeters) | Change from baseline height at 16 weeks | Standing height |
| Muscle fat (%) | Change from baseline muscle fat at 16 weeks | Muscle fat measured by Magnetic Resonance Imaging |
Countries
Canada
Outcome results
None listed