Diabetes Mellitus, Type 1FED-T1DNCT06748963
Fasted Exercise Training in Type 1 Diabetes (FED-T1D)
A study testing Fasted Exercise and Postprandial Exercise in people with Diabetes Mellitus, Type 1, 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 1 diabetes. Training will take place over 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- 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 Jan 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes for 5 or more years.
- Treatment using an insulin pump with no change in treatment modality for > 2 continuous months and willing to share CGM data with the research team. Insulin delivery can be managed using either manual open-loop system (non-AID) or a hybrid closed loop (AID) systems.
- Using rapid (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs.
- HbA1c 7.0-9.9%.
- Have BMI of 25 kg/m2 or above
- Have waist circumference associated with central obesity/metabolic syndrome as per Diabetes Canada definition
Show all 12Show fewer
- 94cm for males of European, Sub-Saharan African, Eastern Mediterranean and Middle Eastern descent
- 90cm for males of South Asian, Chinese, Japanese, South and Central American descent
- 80cm for females
- No history of stroke, myocardial infarction, or coronary artery disease
- Not wearing implantable device such as a pacemaker, neurostimulators, aneurysm clips, metal fragments, epicardial electrodes, cochlear implants, magnetic ocular implants, penile implants, magnetic tissue expander, some types of breast implants, magnetic orthopedic implants, magnetic dental implants, hearing Aids, intravascular implants, for example VCI filters, coils, stents, cardiac septum implants, ventricular bypass devices.
- Use a CGM in routine diabetes management.
Who cannot join
- Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event).
- Restriction in aerobic or resistance exercise due to significant diabetes complications (e.g., severe peripheral neuropathy, active proliferative retinopathy, etc.) or other type of limitations (e.g., orthopedic, severe arthritis, etc.).
- Uncontrolled hypertension (e.g., blood pressure >160 mmHg systolic or >100 mmHg diastolic).
- Implanted device, material, or having a condition contraindicated to MRI.
- Ongoing pregnancy or breastfeeding.
- Inability to give consent.
- Use of an injection-based insulin therapy (ex. multiple daily injections or combined pump and injection-based delivery).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2E1
Normand Boule, PhD, 780-492-4695, nboule@ualberta.ca
Reid McClure, MSc, 780-492-8079, rmcclur1@ualberta.ca
About this study
Official title: Exercise Training Before (Fasted) Versus After (Fed) Breakfast in Type 1 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 1 diabetes. Training will take place over 12 weeks.
Read the detailed description
People with type 1 diabetes (PwT1D) are encouraged to increase their physical activity (PA). Increasing the amount of PA can be difficult, especially for PwT1D who experience barriers to exercise. Therefore, simply recommending that PwT1D preform more exercise may not be the most effective prescription in the long term. Recent short-term studies have s suggest that exercise performed before eating (fasted) causes blood sugars to decrease less or even increase, compared exercise performed after a meal, which usually causes blood sugar to decrease. To date, no long-term study has compared the effects of exercise performed with or without eating beforehand in people with T1D.
This study will compare the effects of 12 weeks of exercise before breakfast compared to 12 weeks of exercise after breakfast. It is expected that exercise before breakfast (i.e., in the fasted state) will lead to larger reductions in overall insulin dose, without the addition of more exercise.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Fasted Exercise, Postprandial Exercise
- Keywords
- Exercise, Continuous glucose monitoring, total daily insulin dose, Muscle fat, Liver fat
- Medical subject headings
- Diabetes Mellitus, Type 1, 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
Participants will complete three sessions of combined resistance-aerobic exercise per week. Sessions will always start with resistance training followed by aerobic training, and will increase in duration throughout the intervention period, so that by the final three weeks of the intervention, all participants accumulate 150 minutes per week of moderate intensity aerobic exercise and 75 minutes of resistance exercise per week. Participants will complete three distinct resistance exercise sessions per week, which will increase in load, but decrease in repetition range throughout the trial. The aerobic component of the exercise sessions will increase in duration from 35 to 50 minutes per session. Participants will walk on a treadmill at a speed and incline that corresponds to 70-80% of ventilatory threshold.
Postprandial ExerciseBehavioural
Participants will complete three sessions of combined resistance-aerobic exercise per week. Sessions will always start with resistance training followed by aerobic training, and will increase in duration throughout the intervention period, so that by the final three weeks of the intervention, all participants accumulate 150 minutes per week of moderate intensity aerobic exercise and 75 minutes of resistance exercise per week. Participants will complete three distinct resistance exercise sessions per week, which will increase in load, but decrease in repetition range throughout the trial. The aerobic component of the exercise sessions will increase in duration from 35 to 50 minutes per session. Participants will walk on a treadmill at a speed and incline that corresponds to 70-80% 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.
Daily insulin dose (units/kg/day)
Total daily insulin dose (including basal and bolus insulin) will be measured over 7 consecutive days.
Measured: From enrolment to the end of the exercise intervention at week 12.
Secondary outcomes (19)
Continuous glucose monitoring
24-hour mean glucose (mmol/L) as measured by continuous glucose monitors.
Measured: From enrolment to the end of the exercise intervention at week 12.
Continuous glucose monitoring
Time in range (%) as measured by continuous glucose monitors.
Measured: From enrolment to the end of the exercise intervention at week 12.
Magnetic resonance imaging (MRI) volumes
MRI derived volumes (e.g., muscle fat, hepatic fat, pancreatic fat, subcutaneous fat, visceral fat)
Measured: From enrolment to the end of the exercise intervention at week 12.
Basal and bolus insulin dose (units/kg/day)
Basal insulin dose (units/kg/day), bolus insulin dose (units/kg/day), and basal to bolus ratio
Measured: From enrolment to the end of the exercise intervention at week 12.
Bioelectrical impedance (BIA) in kilograms
BIA body composition outcomes (e.g., fat mass, fat free mass, total body water), all measured in kilograms
Measured: From enrolment to the end of the exercise intervention at week 12.
Glycated haemoglobin (%)
Hlycated hemoglobine (also known as HbA1c) expressed as a percentage.
Measured: From enrolment to the end of the exercise intervention at week 12.
Concentrations of Fasting glucose
Plasma glucose measured after an overnight fast
Measured: From enrolment to the end of the exercise intervention at week 12.
Concentrations of Fasting insulin
Plasma insulin measured after an overnight fast
Measured: From enrolment to the end of the exercise intervention at week 12.
Concentrations of Fasting lipids
Plasma total cholesterol, HDL-Cholesterol, LDL-Cholesterol and Triglycerides measured after an overnight fast
Measured: From enrolment to the end of the exercise intervention at week 12.
Aerobic fitness
Exercise test to determine ventilatory threshold
Measured: From enrolment to the end of the exercise intervention at week 12.
Body weight (kilograms)
Weight will be measured in kilograms
Measured: From enrolment to the end of the exercise intervention at week 12.
Height (centimeters)
Standing height
Measured: From enrolment to the end of the exercise intervention at week 12.
Waist circumference (centimeters)
Waist circumference (between 12 rib and iliac crest) measures in centimeters
Measured: From enrolment to the end of the exercise intervention at week 12.
Hip circumference (centimeters)
Hip circumference (between 12 rib and iliac crest) measures in centimeters
Measured: From enrolment to the end of the exercise intervention at week 12.
Physical Activity in minutes per day
Accelerometer measured active time (min/day), sedentary time (min/day)
Measured: From enrolment to the end of the exercise intervention at week 12.
Food logs (kilocalories)
Food logs will be completed for three days (two weekday and one weekend) for estimation of macronutrient intake and total energy intake. Each of these will be expressed as kilocalories (i.e., kcal).
Measured: From enrolment to the end of the exercise intervention at week 12.
Feasibility (rates expressed as percentage of the total sample)
Feasibility will include recruitment rate, and dropout rate. Each rate will be reported as the percentage of the total sample.
Measured: From enrolment to the end of the exercise intervention at week 12.
Feasibility (rates expressed as percentage of the total number of sessions)
Feasibility will also include exercise adherence. Adherence will be reported as the percentage of the prescribed exercise sessions that were completed).
Measured: From enrolment to the end of the exercise intervention at week 12.
Feasibility (barriers)
Barriers will bve assessed using the "Barriers to Physical Activity in Type 1 Diabetes" (BAPAD-1) scale. This is a 11-item scale with 7-point Likert-type questions (i.e., each question has a minimum of 1 and a maximum of 7). The maximum score is therefore 77 and minimum score 11. A higher score indicates greater barriers.
Measured: From enrolment to the end of the exercise intervention at week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Model description
- Pre vs post, 2 group parallel study design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Diabetes Institute
- Responsible party
- Sponsor
- Investigators
- Normand G Boule, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748963
- Sponsor's protocol ID
- Pro00140125
- Other IDs
- RES0067483
- Acronym
- FED-T1D
- Status last verified
- May 2026
- First submitted
- 13 Nov 2024
- Last updated
- 8 May 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training Before (Fasted) Versus After (Fed) Breakfast in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06748963
- Acronym / sponsor ID
- FED-T1D / Pro00140125
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Exercise, Continuous glucose monitoring, total daily insulin dose, Muscle fat, Liver fat
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Diabetes Institute
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Dec 2024 (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 1 diabetes. Training will take place over 12 weeks.
Detailed description
People with type 1 diabetes (PwT1D) are encouraged to increase their physical activity (PA). Increasing the amount of PA can be difficult, especially for PwT1D who experience barriers to exercise. Therefore, simply recommending that PwT1D preform more exercise may not be the most effective prescription in the long term. Recent short-term studies have s suggest that exercise performed before eating (fasted) causes blood sugars to decrease less or even increase, compared exercise performed after a meal, which usually causes blood sugar to decrease. To date, no long-term study has compared the effects of exercise performed with or without eating beforehand in people with T1D.
This study will compare the effects of 12 weeks of exercise before breakfast compared to 12 weeks of exercise after breakfast. It is expected that exercise before breakfast (i.e., in the fasted state) will lead to larger reductions in overall insulin dose, without the addition of more exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pre vs post, 2 group parallel study design
| 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
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Clinical diagnosis of type 1 diabetes for 5 or more years.
- Treatment using an insulin pump with no change in treatment modality for > 2 continuous months and willing to share CGM data with the research team. Insulin delivery can be managed using either manual open-loop system (non-AID) or a hybrid closed loop (AID) systems.
- Using rapid (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs.
- HbA1c 7.0-9.9%.
- Have BMI of 25 kg/m2 or above
Key exclusion criteria (7 listed)
- Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event).
- Restriction in aerobic or resistance exercise due to significant diabetes complications (e.g., severe peripheral neuropathy, active proliferative retinopathy, etc.) or other type of limitations (e.g., orthopedic, severe arthritis, etc.).
- Uncontrolled hypertension (e.g., blood pressure >160 mmHg systolic or >100 mmHg diastolic).
- Implanted device, material, or having a condition contraindicated to MRI.
- Ongoing pregnancy or breastfeeding.
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 ExerciseParticipants will complete three sessions of combined resistance-aerobic exercise per week. Sessions will always start with resistance training followed by aerobic training, and will increase in duration throughout the intervention period, so that by the final three weeks of the intervention, all participants accumulate 150 minutes per week of moderate intensity aerobic exercise and 75 minutes of resistance exercise per week. Participants will complete three distinct resistance exercise sessions per week, which will increase in load, but decrease in repetition range throughout the trial. The aerobic component of the exercise sessions will increase in duration from 35 to 50 minutes per session. Participants will walk on a treadmill at a speed and incline that corresponds to 70-80% of ventilatory threshold. | Behavioural | Fasted Exercise |
| Postprandial ExerciseParticipants will complete three sessions of combined resistance-aerobic exercise per week. Sessions will always start with resistance training followed by aerobic training, and will increase in duration throughout the intervention period, so that by the final three weeks of the intervention, all participants accumulate 150 minutes per week of moderate intensity aerobic exercise and 75 minutes of resistance exercise per week. Participants will complete three distinct resistance exercise sessions per week, which will increase in load, but decrease in repetition range throughout the trial. The aerobic component of the exercise sessions will increase in duration from 35 to 50 minutes per session. Participants will walk on a treadmill at a speed and incline that corresponds to 70-80% of ventilatory threshold. | Behavioural | Postprandial Exercise |
Primary outcome
Daily insulin dose (units/kg/day)
Time frame: From enrolment to the end of the exercise intervention at week 12.
Total daily insulin dose (including basal and bolus insulin) will be measured over 7 consecutive days.
19 secondary outcomes
Continuous glucose monitoring
Time frame: From enrolment to the end of the exercise intervention at week 12.
Continuous glucose monitoring
Time frame: From enrolment to the end of the exercise intervention at week 12.
Magnetic resonance imaging (MRI) volumes
Time frame: From enrolment to the end of the exercise intervention at week 12.
Basal and bolus insulin dose (units/kg/day)
Time frame: From enrolment to the end of the exercise intervention at week 12.
Bioelectrical impedance (BIA) in kilograms
Time frame: From enrolment to the end of the exercise intervention at week 12.
Glycated haemoglobin (%)
Time frame: From enrolment to the end of the exercise intervention at week 12.
Concentrations of Fasting glucose
Time frame: From enrolment to the end of the exercise intervention at week 12.
Concentrations of Fasting insulin
Time frame: From enrolment to the end of the exercise intervention at week 12.
Concentrations of Fasting lipids
Time frame: From enrolment to the end of the exercise intervention at week 12.
Aerobic fitness
Time frame: From enrolment to the end of the exercise intervention at week 12.
Body weight (kilograms)
Time frame: From enrolment to the end of the exercise intervention at week 12.
Height (centimeters)
Time frame: From enrolment to the end of the exercise intervention at week 12.
Waist circumference (centimeters)
Time frame: From enrolment to the end of the exercise intervention at week 12.
Hip circumference (centimeters)
Time frame: From enrolment to the end of the exercise intervention at week 12.
Physical Activity in minutes per day
Time frame: From enrolment to the end of the exercise intervention at week 12.
Food logs (kilocalories)
Time frame: From enrolment to the end of the exercise intervention at week 12.
Feasibility (rates expressed as percentage of the total sample)
Time frame: From enrolment to the end of the exercise intervention at week 12.
Feasibility (rates expressed as percentage of the total number of sessions)
Time frame: From enrolment to the end of the exercise intervention at week 12.
Feasibility (barriers)
Time frame: From enrolment to the end of the exercise intervention at week 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- 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.
Normand G Boule, 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 1, 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 12 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Normand Boule, PhD (780-492-4695, nboule@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily insulin dose (units/kg/day) (time frame: From enrolment to the end of the exercise intervention at week 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.