University of Alberta
Edmonton, Alberta, T6G 2E1, Canada
Location status: Recruiting
Location contact
Normand Boule, PhD
CONTACT
Normand Boule, PhD
PRINCIPAL_INVESTIGATOR
Reid McClure, MSc
CONTACT
NCT Number: NCT06748963
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.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Not applicable
Edmonton, Alberta, T6G 2E1, Canada
Location status: Recruiting
Normand Boule, PhD
CONTACT
Normand Boule, PhD
PRINCIPAL_INVESTIGATOR
Reid McClure, MSc
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From enrolment to the end of the exercise intervention at week 12.
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.
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.
Time in range (%) as measured by continuous glucose monitors.
Time frame: From enrolment to the end of the exercise intervention at week 12.
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.
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.
BIA body composition outcomes (e.g., fat mass, fat free mass, total body water), all measured in kilograms
Time frame: From enrolment to the end of the exercise intervention at week 12.
Hlycated hemoglobine (also known as HbA1c) expressed as a percentage.
Time frame: From enrolment to the end of the exercise intervention at week 12.
Plasma glucose measured after an overnight fast
Time frame: From enrolment to the end of the exercise intervention at week 12.
Plasma insulin measured after an overnight fast
Time frame: From enrolment to the end of the exercise intervention at week 12.
Plasma total cholesterol, HDL-Cholesterol, LDL-Cholesterol and Triglycerides measured after an overnight fast
Time frame: From enrolment to the end of the exercise intervention at week 12.
Exercise test to determine ventilatory threshold
Time frame: From enrolment to the end of the exercise intervention at week 12.
Weight will be measured in kilograms
Time frame: From enrolment to the end of the exercise intervention at week 12.
Standing height
Time frame: From enrolment to the end of the exercise intervention at week 12.
Waist circumference (between 12 rib and iliac crest) measures in centimeters
Time frame: From enrolment to the end of the exercise intervention at week 12.
Hip circumference (between 12 rib and iliac crest) measures in centimeters
Time frame: From enrolment to the end of the exercise intervention at week 12.
Accelerometer measured active time (min/day), sedentary time (min/day)
Time frame: From enrolment to the end of the exercise intervention at week 12.
Food logs will be completed for three days (two weekday and one weekend) for estimation of macronutrient intake and total energy intake. Each of these will be expressed as kilocalories (i.e., kcal).
Time frame: From enrolment to the end of the exercise intervention at week 12.
Feasibility will include recruitment rate, and dropout rate. Each rate will be reported as the percentage of the total sample.
Time frame: From enrolment to the end of the exercise intervention at week 12.
Feasibility will also include exercise adherence. Adherence will be reported as the percentage of the prescribed exercise sessions that were completed).
Time frame: From enrolment to the end of the exercise intervention at week 12.
Barriers will bve assessed using the "Barriers to Physical Activity in Type 1 Diabetes" (BAPAD-1) scale. This is a 11-item scale with 7-point Likert-type questions (i.e., each question has a minimum of 1 and a maximum of 7). The maximum score is therefore 77 and minimum score 11. A higher score indicates greater barriers.
Contact information is provided by the study sponsor or research team.
Normand Boule, PhD
CONTACT
Reid McClure, MSc
CONTACT
University of Alberta
Other
Exercise Training Before (Fasted) Versus After (Fed) Breakfast in Type 1 Diabetes
Acronym: FED-T1D
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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