Fasted Exercise Training in Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

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Official title:

Exercise Training Before (Fasted) Versus After Breakfast in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908281
• Other study ID #: Pro00088195
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 31, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Fasted 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.
• Postprandial 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.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration of HbA1c (mmol/mol)	Glycated Hemoglobin	Change from baseline HbA1c at 16 weeks
Primary	Liver fat (%)	Intra-hepatic fat measured by Magnetic Resonance Imaging	Change from baseline liver fat at 16 weeks
Secondary	Pancreatic fat (%)	Pancreatic fat measured by Magnetic Resonance Imaging	Change from pancreatic fat at 16 weeks
Secondary	Muscle fat (%)	Muscle fat measured by Magnetic Resonance Imaging	Change from baseline muscle fat at 16 weeks
Secondary	Concentrations of Fasting glucose	Plasma glucose measured after an overnight fast	Change from baseline fasting glucose at 16 weeks
Secondary	Concentrations of Fasting insulin	Plasma insulin measured after an overnight fast	Change from baseline fasting insulin at 16 weeks
Secondary	Concentrations of Fasting lipids	Plasma total cholesterol, HDL-Cholesterol, LDL-Cholesterol and Triglycerides measured after an overnight fast	Change from baseline fasting lipids at 16 weeks
Secondary	Concentrations of Liver enzymes	Alanine aminotransferase, Aspartate aminotransferase measured after an overnight fast	Change from baseline liver enzymes at 16 weeks
Secondary	Aerobic fitness	Submaximal exercise test to determine ventilatory threshold	Change from baseline aerobic fitness at 16 weeks
Secondary	Height (centimeters)	Standing height	Change from baseline height at 16 weeks
Secondary	Waist circumference (centimeters)	Waist circumference (between 12 rib and iliac crest) measures in centimeters	Change from baseline waist circumference at 16 weeks
Secondary	Hip circumference (centimeters)	Hip circumference (between 12 rib and iliac crest) measures in centimeters	Change from baseline hip circumference at 16 weeks
Secondary	Body weight (kilograms)	Weight will be measured in kilograms	Change from baseline weight at 16 weeks
Secondary	Continuous glucose monitoring	Continuous glucose monitoring outcomes (e.g., 24-hour mean glucose)	Change from the first two to the last two weeks of the 16 week interventions