Fasted Exercise Training in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Fasted Exercise; Behavioral: Postprandial Exercise

• Registration Number: NCT03908281
• Lead Sponsor: University of Alberta

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-09
• Study Start: 2019-09-01
• Primary Completion: 2022-07-11
• Study Completion: 2022-10-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fasted Exercise	Fasted Exercise	Exercise training will be performed in the fasted state (i.e., before breakfast).
Postprandial Exercise	Postprandial Exercise	Exercise will be performed in the postprandial period (i.e., after breakfast)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Concentrations of Liver enzymes	Change from baseline liver enzymes at 16 weeks	Alanine aminotransferase, Aspartate aminotransferase measured after an overnight fast
Muscle fat (%)	Change from baseline muscle fat at 16 weeks	Muscle fat measured by Magnetic Resonance Imaging
Height (centimeters)	Change from baseline height at 16 weeks	Standing height
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)
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
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
Aerobic fitness	Change from baseline aerobic fitness at 16 weeks	Submaximal exercise test to determine ventilatory threshold

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada