Fasted Exercise Training in Type 2 Diabetes

NCT ID: NCT03908281

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-10-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fasted Exercise

Exercise training will be performed in the fasted state (i.e., before breakfast).

Group Type: EXPERIMENTAL

Fasted Exercise

Intervention Type: 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

Exercise will be performed in the postprandial period (i.e., after breakfast)

Group Type: ACTIVE_COMPARATOR

Postprandial Exercise

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Normand Boulé, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

References

Rees JL, Walesiak D, Thompson R, Mager D, Senior P, Boule NG. HbA1c and Liver Fat After 16 Weeks of Fasted versus Fed Exercise Training in Adults With Type 2 Diabetes. Med Sci Sports Exerc. 2025 Jan 1;57(1):106-114. doi: 10.1249/MSS.0000000000003552. Epub 2024 Sep 16.

Reference Type: DERIVED

PMID: 39283231 (View on PubMed)

Other Identifiers

Pro00088195

Identifier Type: -

Identifier Source: org_study_id