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

Official title

Exercise Training Before (Fasted) Versus After (Fed) Breakfast in Type 1 Diabetes

Overview

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.

Interventions

• Behavioral 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
• 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

Primary outcome measures

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

Secondary outcome measures (12)

• 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.]

Eligibility criteria

Inclusion criteria

• 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

• 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.

Exclusion criteria

• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• University of Alberta — Edmonton

Identifiers

NCT: NCT06748963 · Pro00140125 · RES0067483

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗