Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

NCT ID: NCT06748963

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-04-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fasted Exercise

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

Group Type: EXPERIMENTAL

Fasted Exercise

Intervention Type: BEHAVIORAL

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

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

Group Type: ACTIVE_COMPARATOR

Postprandial Exercise

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Diabetes Institute

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Normand G Boule, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Normand Boule, PhD

Role: CONTACT

nboule@ualberta.ca

780-492-4695

Reid McClure, MSc

Role: CONTACT

rmcclur1@ualberta.ca

780-492-8079

Facility Contacts

Normand Boule, PhD

Role: primary

nboule@ualberta.ca

780-492-4695

Reid McClure, MSc

Role: backup

rmcclur1@ualberta.ca

780-492-8079

Other Identifiers

RES0067483

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00140125

Identifier Type: -

Identifier Source: org_study_id