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Completed

NCT Number: NCT03908281

Fasted Exercise Training in Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fasted Exercise

Behavioral

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

Behavioral

Exercise training will take place 3 times per week and will progress to 60 minutes at a workload corresponding to 80% of Ventilatory Threshold.

Primary outcomes

  1. Concentration of HbA1c (mmol/mol)

    Time frame: Change from baseline HbA1c at 16 weeks

    Glycated Hemoglobin

  2. Liver fat (%)

    Time frame: Change from baseline liver fat at 16 weeks

    Intra-hepatic fat measured by Magnetic Resonance Imaging

Secondary outcomes

  1. Pancreatic fat (%)

    Time frame: Change from pancreatic fat at 16 weeks

    Pancreatic fat measured by Magnetic Resonance Imaging

  2. Muscle fat (%)

    Time frame: Change from baseline muscle fat at 16 weeks

    Muscle fat measured by Magnetic Resonance Imaging

  3. Concentrations of Fasting glucose

    Time frame: Change from baseline fasting glucose at 16 weeks

    Plasma glucose measured after an overnight fast

  4. Concentrations of Fasting insulin

    Time frame: Change from baseline fasting insulin at 16 weeks

    Plasma insulin measured after an overnight fast

  5. Concentrations of Fasting lipids

    Time frame: Change from baseline fasting lipids at 16 weeks

    Plasma total cholesterol, HDL-Cholesterol, LDL-Cholesterol and Triglycerides measured after an overnight fast

  6. Concentrations of Liver enzymes

    Time frame: Change from baseline liver enzymes at 16 weeks

    Alanine aminotransferase, Aspartate aminotransferase measured after an overnight fast

  7. Aerobic fitness

    Time frame: Change from baseline aerobic fitness at 16 weeks

    Submaximal exercise test to determine ventilatory threshold

  8. Height (centimeters)

    Time frame: Change from baseline height at 16 weeks

    Standing height

  9. Waist circumference (centimeters)

    Time frame: Change from baseline waist circumference at 16 weeks

    Waist circumference (between 12 rib and iliac crest) measures in centimeters

  10. Hip circumference (centimeters)

    Time frame: Change from baseline hip circumference at 16 weeks

    Hip circumference (between 12 rib and iliac crest) measures in centimeters

  11. Body weight (kilograms)

    Time frame: Change from baseline weight at 16 weeks

    Weight will be measured in kilograms

  12. Continuous glucose monitoring

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: FED

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 9, 2019
Registry last updated
Dec 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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