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| Name | Class |
|---|---|
| North Carolina Diabetes Research Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High intensity interval training, Moderate Intensity Continuous Training, Control | Experimental | 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. |
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| Moderate Intensity Continuous Training, High Intensity Training, Control | Experimental | 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. |
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| Control session, High intensity interval training, moderate intensity continuous training | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Interval Exercise | Other | One session of high intensity interval exercise |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Energy Expenditure Between HIIT and MICT | Energy expenditure measured via indirect calorimetry (kcals) during exercise. | During exercise |
| Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism | Lactate measured using capillary finger prick (mmol/L). | Baseline, 1 hour post exercise |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately post-exercise and Overnight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abbie Smith-Ryan, PhD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Physiology Laboratory | Chapel Hill | North Carolina | 27599 | United States |
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.
Beginning 1 year and ending 2 years following article publication
IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.
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This was a cross-over design with all participants completing all treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Exercise Session |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 17, 2021 |
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| Moderate Intensity Continuous Exercise | Other | One session of calorically matched moderate intensity exercise |
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| Control | Other | No exercise, resting measures |
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| FG001 | 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 |
| FG002 | 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 |
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| NOT COMPLETED |
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| Second Exercise Session |
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| Third Exercise Session |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Percent Body Fat | Body fat percentage determined from whole body dual energy x-ray absorptiometry | Mean | Standard Deviation | percent body fat |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Energy Expenditure Between HIIT and MICT | Energy expenditure measured via indirect calorimetry (kcals) during exercise. | There was no exercise during the control session; therefore, this outcome does not apply for control trial. | Posted | Mean | Standard Deviation | kcal | During exercise |
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| Primary | Difference in Mean Lactate During Exercise as an Indicator of Carbohydrate Metabolism | Lactate measured using capillary finger prick (mmol/L). | There was no exercise during the control session; therefore, this outcome does not apply for control trial. | Posted | Mean | Standard Deviation | mmol/L | Baseline, 1 hour post exercise |
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| 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. | Posted | Mean | Standard Deviation | mg/dL | Immediately post-exercise and Overnight |
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From the time of signing the informed consent through the end of the study, a total of up to approximately 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Intensity Interval Training | High Intensity Interval Exercise: One session of high intensity interval exercise | 0 | 14 | 0 | 14 | 0 | 14 |
| EG001 | Moderate Intensity Continuous Training | Moderate Intensity Continuous Exercise: One session of calorically matched moderate intensity exercise | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Control Session | Control: No exercise, resting measures | 0 | 14 | 0 | 14 | 0 | 14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abbie Smith-Ryan, PhD | University of North Carolina at Chapel Hill | 919-962-2574 | abbsmith@email.unc.edu |
| Feb 8, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 17, 2021 | Feb 8, 2024 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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