RecruitingNot ApplicableNCT06748963

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

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


Sponsor

University of Alberta

Enrollment

20 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria12

  • 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
  • cm for males of European, Sub-Saharan African, Eastern Mediterranean and Middle Eastern descent
  • cm for males of South Asian, Chinese, Japanese, South and Central American descent
  • cm 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 Criteria7

  • 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).

Interventions

BEHAVIORALFasted 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.

BEHAVIORALPostprandial 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.


Locations(1)

University of Alberta

Edmonton, Alberta, Canada

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NCT06748963


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