Diabetes Mellitus, Type 2FEDNCT03908281
Fasted Exercise Training in Type 2 Diabetes
A study testing Fasted Exercise and Postprandial Exercise in people with Diabetes Mellitus, Type 2, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Fasted Exercise and Postprandial Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Fasted Exercise, Postprandial Exercise
- Keywords
- Exercise, Glycated hemoglobin, Liver fat, Continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasted ExerciseBehavioural
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 ExerciseBehavioural
Exercise training will take place 3 times per week and will progress to 60 minutes at a workload corresponding to 80% of Ventilatory Threshold.
| Study group | Role | What they receive |
|---|---|---|
| Fasted Exercise | Experimental | Exercise training will be performed in the fasted state (i.e., before breakfast). Receives: Behavioral: Fasted Exercise |
| Postprandial Exercise | Active comparator | Exercise will be performed in the postprandial period (i.e., after breakfast) Receives: Behavioral: Postprandial Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of HbA1c (mmol/mol)
Glycated Hemoglobin
Measured: Change from baseline HbA1c at 16 weeks
Liver fat (%)
Intra-hepatic fat measured by Magnetic Resonance Imaging
Measured: Change from baseline liver fat at 16 weeks
Secondary outcomes (12)
Pancreatic fat (%)
Pancreatic fat measured by Magnetic Resonance Imaging
Measured: Change from pancreatic fat at 16 weeks
Muscle fat (%)
Muscle fat measured by Magnetic Resonance Imaging
Measured: Change from baseline muscle fat at 16 weeks
Concentrations of Fasting glucose
Plasma glucose measured after an overnight fast
Measured: Change from baseline fasting glucose at 16 weeks
Concentrations of Fasting insulin
Plasma insulin measured after an overnight fast
Measured: 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
Measured: Change from baseline fasting lipids at 16 weeks
Concentrations of Liver enzymes
Alanine aminotransferase, Aspartate aminotransferase measured after an overnight fast
Measured: Change from baseline liver enzymes at 16 weeks
Aerobic fitness
Submaximal exercise test to determine ventilatory threshold
Measured: Change from baseline aerobic fitness at 16 weeks
Height (centimeters)
Standing height
Measured: Change from baseline height at 16 weeks
Waist circumference (centimeters)
Waist circumference (between 12 rib and iliac crest) measures in centimeters
Measured: Change from baseline waist circumference at 16 weeks
Hip circumference (centimeters)
Hip circumference (between 12 rib and iliac crest) measures in centimeters
Measured: Change from baseline hip circumference at 16 weeks
Body weight (kilograms)
Weight will be measured in kilograms
Measured: Change from baseline weight at 16 weeks
Continuous glucose monitoring
Continuous glucose monitoring outcomes (e.g., 24-hour mean glucose)
Measured: Change from the first two to the last two weeks of the 16 week interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 Sep 2019
- Primary completion11 Jul 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Normand Boulé, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908281
- Sponsor's protocol ID
- Pro00088195
- Acronym
- FED
- Status last verified
- Nov 2022
- First submitted
- 4 Apr 2019
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39283231
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training Before (Fasted) Versus After Breakfast in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03908281
- Acronym / sponsor ID
- FED / Pro00088195
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Exercise, Glycated hemoglobin, Liver fat, Continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 11 Jul 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasted Exercise | Experimental | Behavioral: Fasted ExerciseExercise training will be performed in the fasted state (i.e., before breakfast). |
| Postprandial Exercise | Active comparator | Behavioral: Postprandial ExerciseExercise will be performed in the postprandial period (i.e., after breakfast) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasted ExerciseExercise training will take place 3 times per week and will progress to 60 minutes at a workload corresponding to 80% of Ventilatory Threshold. | Behavioural | Fasted Exercise |
| Postprandial ExerciseExercise training will take place 3 times per week and will progress to 60 minutes at a workload corresponding to 80% of Ventilatory Threshold. | Behavioural | Postprandial Exercise |
Primary outcome
Concentration of HbA1c (mmol/mol)
Time frame: Change from baseline HbA1c at 16 weeks
Glycated Hemoglobin
Liver fat (%)
Time frame: Change from baseline liver fat at 16 weeks
Intra-hepatic fat measured by Magnetic Resonance Imaging
12 secondary outcomes
Pancreatic fat (%)
Time frame: Change from pancreatic fat at 16 weeks
Muscle fat (%)
Time frame: Change from baseline muscle fat at 16 weeks
Concentrations of Fasting glucose
Time frame: Change from baseline fasting glucose at 16 weeks
Concentrations of Fasting insulin
Time frame: Change from baseline fasting insulin at 16 weeks
Concentrations of Fasting lipids
Time frame: Change from baseline fasting lipids at 16 weeks
Concentrations of Liver enzymes
Time frame: Change from baseline liver enzymes at 16 weeks
Aerobic fitness
Time frame: Change from baseline aerobic fitness at 16 weeks
Height (centimeters)
Time frame: Change from baseline height at 16 weeks
Waist circumference (centimeters)
Time frame: Change from baseline waist circumference at 16 weeks
Hip circumference (centimeters)
Time frame: Change from baseline hip circumference at 16 weeks
Body weight (kilograms)
Time frame: Change from baseline weight at 16 weeks
Continuous glucose monitoring
Time frame: Change from the first two to the last two weeks of the 16 week interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Derived from this study: PubMed 39283231Rees 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Normand Boulé, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasted Exercise and Postprandial Exercise in people with Diabetes Mellitus, Type 2, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of HbA1c (mmol/mol) (time frame: Change from baseline HbA1c at 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03908281, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.