Clinical trial NCT03908281: Fasted Exercise Training in Type 2 Diabetes
Official title: Exercise Training Before (Fasted) Versus After Breakfast in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Exercise
Glycated hemoglobin
Liver fat
Continuous glucose monitoring
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concentration of HbA1c (mmol/mol)
timeFrame: Change from baseline HbA1c at 16 weeks
measure: Liver fat (%)
timeFrame: Change from baseline liver fat at 16 weeks
Secondary outcomes:
measure: Pancreatic fat (%)
timeFrame: Change from pancreatic fat at 16 weeks
measure: Muscle fat (%)
timeFrame: Change from baseline muscle fat at 16 weeks
measure: Concentrations of Fasting glucose
timeFrame: Change from baseline fasting glucose at 16 weeks
measure: Concentrations of Fasting insulin
timeFrame: Change from baseline fasting insulin at 16 weeks
measure: Concentrations of Fasting lipids
timeFrame: Change from baseline fasting lipids at 16 weeks
measure: Concentrations of Liver enzymes
timeFrame: Change from baseline liver enzymes at 16 weeks
measure: Aerobic fitness
timeFrame: Change from baseline aerobic fitness at 16 weeks
measure: Height (centimeters)
timeFrame: Change from baseline height at 16 weeks
measure: Waist circumference (centimeters)
timeFrame: Change from baseline waist circumference at 16 weeks
measure: Hip circumference (centimeters)
timeFrame: Change from baseline hip circumference at 16 weeks
measure: Body weight (kilograms)
timeFrame: Change from baseline weight at 16 weeks
measure: Continuous glucose monitoring
timeFrame: Change from the first two to the last two weeks of the 16 week interventions
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Normand Boulé, PhD
role: PRINCIPAL_INVESTIGATOR
References: