Fasted Exercise Training in Type 2 Diabetes (FED)

Exercise Training Before (Fasted) Versus After Breakfast 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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Fasted Exercise; Behavioral: Postprandial Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2E1
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fasted Exercise; Exercise training will be performed in the fasted state (i.e., before breakfast).	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.
ACTIVE_COMPARATOR: Postprandial Exercise; Exercise will be performed in the postprandial period (i.e., after breakfast)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of HbA1c (mmol/mol)	Glycated Hemoglobin	Change from baseline HbA1c at 16 weeks
Liver fat (%)	Intra-hepatic fat measured by Magnetic Resonance Imaging	Change from baseline liver fat at 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pancreatic fat (%)	Pancreatic fat measured by Magnetic Resonance Imaging	Change from pancreatic fat at 16 weeks
Muscle fat (%)	Muscle fat measured by Magnetic Resonance Imaging	Change from baseline muscle fat at 16 weeks
Concentrations of Fasting glucose	Plasma glucose measured after an overnight fast	Change from baseline fasting glucose at 16 weeks
Concentrations of Fasting insulin	Plasma insulin measured after an overnight fast	Change from baseline fasting insulin at 16 weeks
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
Concentrations of Liver enzymes	Alanine aminotransferase, Aspartate aminotransferase measured after an overnight fast	Change from baseline liver enzymes at 16 weeks
Aerobic fitness	Submaximal exercise test to determine ventilatory threshold	Change from baseline aerobic fitness at 16 weeks
Height (centimeters)	Standing height	Change from baseline height at 16 weeks
Waist circumference (centimeters)	Waist circumference (between 12 rib and iliac crest) measures in centimeters	Change from baseline waist circumference at 16 weeks
Hip circumference (centimeters)	Hip circumference (between 12 rib and iliac crest) measures in centimeters	Change from baseline hip circumference at 16 weeks
Body weight (kilograms)	Weight will be measured in kilograms	Change from baseline weight at 16 weeks
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

Collaborators and Investigators

• Sponsor: University of Alberta

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): July 11, 2022
• Study Completion (ACTUAL): October 31, 2022

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (ACTUAL): April 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Glycated hemoglobin; Continuous glucose monitoring; Liver fat
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Pro00088195

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to share all of the data related to study outcomes pm am open access website through the University of Alberta "Education and Research Archive" (ERA). Individual participant characteristics that could be used to identify participants (age, sex, height, weight) will not be be placed on ERA.
• IPD Sharing Time Frame: The data will become available one year after the completion of the trial.
• IPD Sharing Access Criteria: The outcome data will be open access through the University of Alberta "Education and Research Archive" (ERA) website. Other participant characteristics will be available as meta-data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No