Trial Outcomes & Findings for Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes (NCT NCT04664205)
NCT ID: NCT04664205
Last Updated: 2024-07-26
Results Overview
Energy expenditure measured via indirect calorimetry (kcals) during exercise.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
During exercise
Results posted on
2024-07-26
Participant Flow
This was a cross-over design with all participants completing all treatments.
Participant milestones
| Measure |
High Intensity Interval Training, Moderate Intensity Continuous Training, Control
Participants randomly assigned to this arm will first receive high intensity interval training and then randomly assigned to both moderate intensity continuous training and control session, on different days.
High Intensity Interval Exercise: One session of high intensity interval exercise
Moderate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise
Control: No exercise, resting measures
|
Moderate Intensity Continuous Training, High Intensity Training, Control
Participants randomly assigned to this arm will first receive moderate intensity continuous training then randomly assigned to both high intensity interval training and a control session, on different days.
High Intensity Interval Exercise: One session of high intensity interval exercise
Moderate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise
Control: No exercise, resting measures
|
Control Session, High Intensity Interval Training, Moderate Intensity Continuous Training
Participants randomly assigned to this arm will first complete a control session (no exercise) and then randomly assigned to both by a high intensity interval training and moderate intensity continuous training session, on different days.
High Intensity Interval Exercise: One session of high intensity interval exercise
Moderate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise
Control: No exercise, resting measures
|
|---|---|---|---|
|
First Exercise Session
STARTED
|
6
|
5
|
3
|
|
First Exercise Session
COMPLETED
|
6
|
5
|
3
|
|
First Exercise Session
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Exercise Session
STARTED
|
6
|
5
|
3
|
|
Second Exercise Session
COMPLETED
|
6
|
5
|
3
|
|
Second Exercise Session
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Exercise Session
STARTED
|
6
|
5
|
3
|
|
Third Exercise Session
COMPLETED
|
6
|
5
|
3
|
|
Third Exercise Session
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Isoenergetic High Intensity Interval Training and Moderate Intensity Training in Adults With Type I Diabetes
Baseline characteristics by cohort
| Measure |
All Participants
n=14 Participants
All participants were randomly assigned to receive control session, high intensity interval training, and moderate intensity continuous training on different days.
High Intensity Interval Exercise: One session of high intensity interval exercise
Moderate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise
Control: No exercise, resting measures
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
|
Percent Body Fat
|
26.6 percent body fat
STANDARD_DEVIATION 11.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: During exercisePopulation: There was no exercise during the control session; therefore, this outcome does not apply for control trial.
Energy expenditure measured via indirect calorimetry (kcals) during exercise.
Outcome measures
| Measure |
High Intensity Interval Training
n=14 Participants
High Intensity Interval Exercise: One session of high intensity interval exercise
|
Moderate Intensity Continuous Training
n=14 Participants
Moderate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise
|
Control Session
Control: No exercise, resting measures
|
|---|---|---|---|
|
Mean Energy Expenditure Between HIIT and MICT
|
264.5 kcal
Standard Deviation 80.9
|
225.5 kcal
Standard Deviation 57.4
|
—
|
PRIMARY outcome
Timeframe: Baseline, 1 hour post exercisePopulation: There was no exercise during the control session; therefore, this outcome does not apply for control trial.
Lactate measured using capillary finger prick (mmol/L).
Outcome measures
| Measure |
High Intensity Interval Training
n=14 Participants
High Intensity Interval Exercise: One session of high intensity interval exercise
|
Moderate Intensity Continuous Training
n=14 Participants
Moderate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise
|
Control Session
Control: No exercise, resting measures
|
|---|---|---|---|
|
Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism
During exercise
|
8.46 mmol/L
Standard Deviation 2.83
|
7.11 mmol/L
Standard Deviation 2.19
|
—
|
|
Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism
1 hour post
|
2.30 mmol/L
Standard Deviation 1.05
|
1.75 mmol/L
Standard Deviation 0.46
|
—
|
SECONDARY outcome
Timeframe: Immediately post-exercise and OvernightGlucose monitoring using a continuous glucose monitor (mg/dL). Overnight values were collected based on the average mid-point of participants' sleep.
Outcome measures
| Measure |
High Intensity Interval Training
n=14 Participants
High Intensity Interval Exercise: One session of high intensity interval exercise
|
Moderate Intensity Continuous Training
n=14 Participants
Moderate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise
|
Control Session
n=14 Participants
Control: No exercise, resting measures
|
|---|---|---|---|
|
Change in Continuous Glucose After Exercise Into Overnight
Immediately post exercise
|
155.2 mg/dL
Standard Deviation 11.3
|
146.9 mg/dL
Standard Deviation 8.0
|
124.5 mg/dL
Standard Deviation 6.3
|
|
Change in Continuous Glucose After Exercise Into Overnight
Overnight
|
139.7 mg/dL
Standard Deviation 18.7
|
165.6 mg/dL
Standard Deviation 6.0
|
150.3 mg/dL
Standard Deviation 7.6
|
Adverse Events
High Intensity Interval Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Intensity Continuous Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Session
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Abbie Smith-Ryan, PhD
University of North Carolina at Chapel Hill
Phone: 919-962-2574
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place