Diabetes Mellitus, Type 1
Conditions
Brief summary
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.
Interventions
One session of high intensity interval exercise
One session of calorically matched moderate intensity exercise
OTHERControl
No exercise, resting measures
Sponsors
University of North Carolina, Chapel Hill
North Carolina Diabetes Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 51 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of presumed autoimmune T1D, receiving daily insulin * Last hemoglobin A1c \<9% * 18-51 years * Duration of T1D: ≥ 1 year * Body mass index (BMI) \<30 kg/m\^2 * Generally healthy, with no conditions that could influence the outcome of the trial, and in the judgement of the investigators is a good candidate for the study, based on a review of health history
Exclusion criteria
* Physician diagnosis of active diabetic retinopathy that could be worsened by exercise * Physician diagnosis of peripheral neuropathy with insensate feet * Physician diagnosis of autonomic neuropathy * Medications: beta-blockers, agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives; any hypoglycemic agent other than insulin. * Severe hypoglycemic event defined as the individual requiring a third party of hospitalization in the last 6 months * Diabetic ketoacidosis in the last 6 months * Has a closed-loop pump and not willing to use manual mode * Physician diagnosis of cardiovascular disease that would affect exercise tolerance * Currently doing HIIT * Severely impaired hearing or speech * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Energy Expenditure Between HIIT and MICT | During exercise | Energy expenditure measured via indirect calorimetry (kcals) during exercise. |
| Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism | Baseline, 1 hour post exercise | Lactate measured using capillary finger prick (mmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Continuous Glucose After Exercise Into Overnight | Immediately post-exercise and Overnight | Glucose monitoring using a continuous glucose monitor (mg/dL). Overnight values were collected based on the average mid-point of participants' sleep. |
Countries
United States
Participant flow
Pre-assignment details
This was a cross-over design with all participants completing all treatments.
Participants by arm
| Arm | Count |
|---|---|
| All 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 | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Percent Body Fat | 26.6 percent body fat STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 14 |
Outcome results
Primary
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
Population: There was no exercise during the control session; therefore, this outcome does not apply for control trial.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity Interval Training | Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism | During exercise | 8.46 mmol/L | Standard Deviation 2.83 |
| High Intensity Interval Training | Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism | 1 hour post | 2.30 mmol/L | Standard Deviation 1.05 |
| Moderate Intensity Continuous Training | Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism | During exercise | 7.11 mmol/L | Standard Deviation 2.19 |
| Moderate Intensity Continuous Training | Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism | 1 hour post | 1.75 mmol/L | Standard Deviation 0.46 |
p-value: 0.069ANCOVA
Primary
Mean Energy Expenditure Between HIIT and MICT
Energy expenditure measured via indirect calorimetry (kcals) during exercise.
Time frame: During exercise
Population: There was no exercise during the control session; therefore, this outcome does not apply for control trial.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Intensity Interval Training | Mean Energy Expenditure Between HIIT and MICT | 264.5 kcal | Standard Deviation 80.9 |
| Moderate Intensity Continuous Training | Mean Energy Expenditure Between HIIT and MICT | 225.5 kcal | Standard Deviation 57.4 |
p-value: 0.01t-test, 2 sided
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Intensity Interval Training | Change in Continuous Glucose After Exercise Into Overnight | Immediately post exercise | 155.2 mg/dL | Standard Deviation 11.3 |
| High Intensity Interval Training | Change in Continuous Glucose After Exercise Into Overnight | Overnight | 139.7 mg/dL | Standard Deviation 18.7 |
| Moderate Intensity Continuous Training | Change in Continuous Glucose After Exercise Into Overnight | Immediately post exercise | 146.9 mg/dL | Standard Deviation 8 |
| Moderate Intensity Continuous Training | Change in Continuous Glucose After Exercise Into Overnight | Overnight | 165.6 mg/dL | Standard Deviation 6 |
| Control Session | Change in Continuous Glucose After Exercise Into Overnight | Immediately post exercise | 124.5 mg/dL | Standard Deviation 6.3 |
| Control Session | Change in Continuous Glucose After Exercise Into Overnight | Overnight | 150.3 mg/dL | Standard Deviation 7.6 |
p-value: 0.478ANOVA