Recruiting

Fasted Exercise Training

Sponsor:

University of Alberta

Code:

NCT06748963

Conditions

Diabetes Mellitus, Type 1

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Fasted Exercise

Postprandial Exercise

Study Details

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 1 diabetes. Training will take place over 12 weeks.

Conditions

Diabetes Mellitus, Type 1

Study ID

NCT06748963

Start date

Jan 1, 2025

Status verified date

May, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes for 5 or more years.
2. 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.
3. Using rapid (e.g., Aspart, Lispro or Glulisine) or ultra-rapid (e.g., FiAsp) acting insulin analogs.
4. HbA1c 7.0-9.9%.
5. Have BMI of 25 kg/m2 or above
6. Have waist circumference associated with central obesity/metabolic syndrome as per Diabetes Canada definition

  • 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
7. No history of stroke, myocardial infarction, or coronary artery disease
8. 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.
9. Use a CGM in routine diabetes management.

Exclusion Criteria:

1. Major complication within the previous 3 months (e.g., severe hypoglycemia requiring assistance, diabetic ketoacidosis, or cardiovascular event).
2. 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.).
3. Uncontrolled hypertension (e.g., blood pressure >160 mmHg systolic or >100 mmHg diastolic).
4. Implanted device, material, or having a condition contraindicated to MRI.
5. Ongoing pregnancy or breastfeeding.
6. Inability to give consent.
7. Use of an injection-based insulin therapy (ex. multiple daily injections or combined pump and injection-based delivery).

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fasted Exercise

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

active comparator: Postprandial Exercise

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

Interventions

Fasted Exercise

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 Exercise

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.

Primary outcome measure

  • Daily insulin dose (units/kg/day) [ Time Frame: From enrolment to the end of the exercise intervention at week 12. ]

Central Contacts and Locations

Central contacts

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G 2E1

Contacts

Principal Investigator:

Normand Boule, PhD

More Information

Sponsor

University of Alberta

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Exercise
  • Continuous glucose monitoring
  • total daily insulin dose
  • Muscle fat
  • Liver fat

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-05-08.