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Fasted Exercise Training in Type 2 Diabetes (FED)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fasted Exercise
Postprandial Exercise
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Exercise, Glycated hemoglobin, Liver fat, Continuous glucose monitoring

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fasted Exercise

Postprandial Exercise

Arm Description

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

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

Outcomes

Primary Outcome Measures

Concentration of HbA1c (mmol/mol)
Glycated Hemoglobin
Liver fat (%)
Intra-hepatic fat measured by Magnetic Resonance Imaging

Secondary Outcome Measures

Pancreatic fat (%)
Pancreatic fat measured by Magnetic Resonance Imaging
Muscle fat (%)
Muscle fat measured by Magnetic Resonance Imaging
Concentrations of Fasting glucose
Plasma glucose measured after an overnight fast
Concentrations of Fasting insulin
Plasma insulin measured after an overnight fast
Concentrations of Fasting lipids
Plasma total cholesterol, HDL-Cholesterol, LDL-Cholesterol and Triglycerides measured after an overnight fast
Concentrations of Liver enzymes
Alanine aminotransferase, Aspartate aminotransferase measured after an overnight fast
Aerobic fitness
Submaximal exercise test to determine ventilatory threshold
Height (centimeters)
Standing height
Waist circumference (centimeters)
Waist circumference (between 12 rib and iliac crest) measures in centimeters
Hip circumference (centimeters)
Hip circumference (between 12 rib and iliac crest) measures in centimeters
Body weight (kilograms)
Weight will be measured in kilograms
Continuous glucose monitoring
Continuous glucose monitoring outcomes (e.g., 24-hour mean glucose)

Full Information

First Posted
April 4, 2019
Last Updated
November 29, 2022
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT03908281
Brief Title
Fasted Exercise Training in Type 2 Diabetes
Acronym
FED
Official Title
Exercise Training Before (Fasted) Versus After Breakfast in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
July 11, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Exercise, Glycated hemoglobin, Liver fat, Continuous glucose monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
For most outcomes, including the primary outcome, the outcome assessor will be unaware of group allocation.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fasted Exercise
Arm Type
Experimental
Arm Description
Exercise training will be performed in the fasted state (i.e., before breakfast).
Arm Title
Postprandial Exercise
Arm Type
Active Comparator
Arm Description
Exercise will be performed in the postprandial period (i.e., after breakfast)
Intervention Type
Behavioral
Intervention Name(s)
Fasted Exercise
Intervention Description
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
Intervention Name(s)
Postprandial Exercise
Intervention Description
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 Outcome Measure Information:
Title
Concentration of HbA1c (mmol/mol)
Description
Glycated Hemoglobin
Time Frame
Change from baseline HbA1c at 16 weeks
Title
Liver fat (%)
Description
Intra-hepatic fat measured by Magnetic Resonance Imaging
Time Frame
Change from baseline liver fat at 16 weeks
Secondary Outcome Measure Information:
Title
Pancreatic fat (%)
Description
Pancreatic fat measured by Magnetic Resonance Imaging
Time Frame
Change from pancreatic fat at 16 weeks
Title
Muscle fat (%)
Description
Muscle fat measured by Magnetic Resonance Imaging
Time Frame
Change from baseline muscle fat at 16 weeks
Title
Concentrations of Fasting glucose
Description
Plasma glucose measured after an overnight fast
Time Frame
Change from baseline fasting glucose at 16 weeks
Title
Concentrations of Fasting insulin
Description
Plasma insulin measured after an overnight fast
Time Frame
Change from baseline fasting insulin at 16 weeks
Title
Concentrations of Fasting lipids
Description
Plasma total cholesterol, HDL-Cholesterol, LDL-Cholesterol and Triglycerides measured after an overnight fast
Time Frame
Change from baseline fasting lipids at 16 weeks
Title
Concentrations of Liver enzymes
Description
Alanine aminotransferase, Aspartate aminotransferase measured after an overnight fast
Time Frame
Change from baseline liver enzymes at 16 weeks
Title
Aerobic fitness
Description
Submaximal exercise test to determine ventilatory threshold
Time Frame
Change from baseline aerobic fitness at 16 weeks
Title
Height (centimeters)
Description
Standing height
Time Frame
Change from baseline height at 16 weeks
Title
Waist circumference (centimeters)
Description
Waist circumference (between 12 rib and iliac crest) measures in centimeters
Time Frame
Change from baseline waist circumference at 16 weeks
Title
Hip circumference (centimeters)
Description
Hip circumference (between 12 rib and iliac crest) measures in centimeters
Time Frame
Change from baseline hip circumference at 16 weeks
Title
Body weight (kilograms)
Description
Weight will be measured in kilograms
Time Frame
Change from baseline weight at 16 weeks
Title
Continuous glucose monitoring
Description
Continuous glucose monitoring outcomes (e.g., 24-hour mean glucose)
Time Frame
Change from the first two to the last two weeks of the 16 week interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Normand Boulé, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://era.library.ualberta.ca

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Fasted Exercise Training in Type 2 Diabetes

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