Fasted Exercise Training in Type 1 Diabetes (FED-T1D)
ConditionDiabetes Mellitus, Type 1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of Alberta
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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%.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Fasted Exercise
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Fasted ExerciseExperimental treatment 1 intervention
Group B: Postprandial ExerciseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Daily insulin dose (units/kg/day)
Total daily insulin dose (including basal and bolus insulin) will be measured over 7 consecutive days.
Time frame
From enrolment to the end of the exercise intervention at week 12.Secondary outcomes
1
Continuous glucose monitoring
24-hour mean glucose (mmol/L) as measured by continuous glucose monitors.
Time frame
From enrolment to the end of the exercise intervention at week 12.2
Continuous glucose monitoring
Time in range (%) as measured by continuous glucose monitors.
Time frame
From enrolment to the end of the exercise intervention at week 12.3
Magnetic resonance imaging (MRI) volumes
MRI derived volumes (e.g., muscle fat, hepatic fat, pancreatic fat, subcutaneous fat, visceral fat)
Time frame
From enrolment to the end of the exercise intervention at week 12.4
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
Time frame
From enrolment to the end of the exercise intervention at week 12.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alberta
Lead sponsor
Alberta Diabetes Institute
Collaborator
Source ClinicalTrials.gov