An interventional study of High Intensity Interval Exercise and Moderate Intensity Continuous Exercise in Diabetes Mellitus, Type 1, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years to 51 Years. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Supportive care
Type 1 diabetes (T1D) is associated with increased risk of poor cardiometabolic health. Regular exercise is recommended for optimal management of comorbidities in T1D. Unique barriers to exercise exist for T1D, including fear of hypoglycemia, unpredictable glycemic excursions with exercise, and inadequate knowledge about exercise. Unlike traditional moderate intensity continuous training (MICT) which requires extended periods of time, high intensity interval training (HIIT) requires minimal time (\~10 minutes of exercise per session), with the potential to rapidly stimulate mitochondrial biogenesis and metabolism. The extent to which these exercise strategies alter metabolomic signatures of carbohydrate, fat, and amino acid metabolism in T1D is unknown. The overall goal of the proposed project is to identify the acute metabolic effects and physiological modifiers of HIIT compared to MICT and control (CON) using metabolomic profiling and cardiometabolic assessments in 14 adults with T1D. Using a randomized cross-over approach, the primary aim is to compare the metabolomics response immediately post, 1 hr post, and glycemic control through 48 hrs after HIIT, compared to MICT matched for total energy expenditure, versus a no exercise CON. An additional aim will be to characterize the influence of biological sex and physiological outcomes (i.e. body composition, lean mass, visceral fat) on the metabolomics profile of these subjects. Outcomes from the present study, with existing data from our team, will lay the foundation for a larger diet and exercise lifestyle intervention that will ultimately lead to changes in clinical practice to co-manage glycemia and cardiometabolic comorbidities.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 14 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: High Intensity Interval Exercise · Other: Moderate Intensity Continuous Exercise · Other: 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.
Other: High Intensity Interval Exercise · Other: Moderate Intensity Continuous Exercise · Other: Control
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.
Other: High Intensity Interval Exercise · Other: Moderate Intensity Continuous Exercise · Other: Control
One session of high intensity interval exercise
One session of calorically matched moderate intensity exercise
No exercise, resting measures
Mean Energy Expenditure Between HIIT and MICT
Energy expenditure measured via indirect calorimetry (kcals) during exercise.
Time frame: During exercise
Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism
Lactate measured using capillary finger prick (mmol/L).
Time frame: Baseline, 1 hour post exercise
Change in Continuous Glucose After Exercise Into Overnight
Glucose monitoring using a continuous glucose monitor (mg/dL). Overnight values were collected based on the average mid-point of participants' sleep.
Time frame: Immediately post-exercise and Overnight
| Milestone | High Intensity Interval Training, Moderate Intensity Continuous Training, Control | Moderate Intensity Continuous Training, High Intensity Training, Control | Control Session, High Intensity Interval Training, Moderate Intensity Continuous Training |
|---|---|---|---|
| Started | 6 | 5 | 3 |
| Completed | 6 | 5 | 3 |
| Not completed | 0 | 0 | 0 |
| Milestone | High Intensity Interval Training, Moderate Intensity Continuous Training, Control | Moderate Intensity Continuous Training, High Intensity Training, Control | Control Session, High Intensity Interval Training, Moderate Intensity Continuous Training |
|---|---|---|---|
| Started | 6 | 5 | 3 |
| Completed | 6 | 5 | 3 |
| Not completed | 0 | 0 | 0 |
| Milestone | High Intensity Interval Training, Moderate Intensity Continuous Training, Control | Moderate Intensity Continuous Training, High Intensity Training, Control | Control Session, High Intensity Interval Training, Moderate Intensity Continuous Training |
|---|---|---|---|
| Started | 6 | 5 | 3 |
| Completed | 6 | 5 | 3 |
| Not completed | 0 | 0 | 0 |
Energy expenditure measured via indirect calorimetry (kcals) during exercise.
| kcal | High Intensity Interval Training | Moderate Intensity Continuous Training | Control Session |
|---|---|---|---|
| Mean Energy Expenditure Between HIIT and MICT | 264.5 ± 80.9 | 225.5 ± 57.4 | — |
Lactate measured using capillary finger prick (mmol/L).
| mmol/L | High Intensity Interval Training | Moderate Intensity Continuous Training | Control Session |
|---|---|---|---|
| During exercise | 8.46 ± 2.83 | 7.11 ± 2.19 | — |
| 1 hour post | 2.30 ± 1.05 | 1.75 ± 0.46 | — |
Glucose monitoring using a continuous glucose monitor (mg/dL). Overnight values were collected based on the average mid-point of participants' sleep.
| mg/dL | High Intensity Interval Training | Moderate Intensity Continuous Training | Control Session |
|---|---|---|---|
| Immediately post exercise | 155.2 ± 11.3 | 146.9 ± 8.0 | 124.5 ± 6.3 |
| Overnight | 139.7 ± 18.7 | 165.6 ± 6.0 | 150.3 ± 7.6 |
Collected over From the time of signing the informed consent through the end of the study, a total of up to approximately 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Intensity Interval Training | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Moderate Intensity Continuous Training | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Control Session | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 7 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United States | 14 |
| Percent Body Fat(percent body fat) | All Participants |
|---|---|
| Mean | 26.6 ± 11.0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill