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Funding for the study was not renewed
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| Name | Class |
|---|---|
| Manitoba Institute of Child Health | INDUSTRY |
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Background/Justification: Regular physical activity (PA) has substantial health benefits in persons with type 1 diabetes (T1D), including reduced risk of complications and cardiovascular mortality. Despite these benefits, individuals with T1D remain significantly less active than their peers without diabetes. Two major factors likely explain the low rates of PA in young people with T1D: (1) fear of post-exercise hypoglycaemia, particularly nocturnal hypoglycaemia, and (2) a lack of empirical evidence for the efficacy of PA for achieving optimal glycaemic control. A number of acute exercise trials recently demonstrated that the inclusion of vigorous intensity PA in conventional moderate intensity (i.e. walking) PA sessions may overcome these limitations. No studies have tested the efficacy of high intensity PA for reducing the risk of exercise-related hypoglycaemia or glycaemic variability in a randomized controlled trial (RCT).
Study Hypotheses: In persons 15-35 years of age living with T1D, this study will test the hypotheses that (1) the addition of intermittent vigorous intensity PA to a moderate intensity intervention will reduce the time spent in hypoglycaemia in the 12 hour period following exercise and (2) the addition of intermittent vigorous intensity PA to a moderate intensity PA intervention will elicit significant improvements in glycemic excursions, as measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour period following exercise.We are also exploring the hypothesis that reducing the risk of hypoglycemia will lead to a sustained increase in physical activity one year after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate intensity exercise | Active Comparator | 150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness) |
|
| Moderate + Vigorous Intensity Exercise | Active Comparator | 150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Training | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent in Hypoglycaemia in the 12-hour Period Following Exercise, Defined as an Interstitial Glucose Reading <4.0mmol/L and Measured by Continuous Glucose Monitor. | Measured at baseline, and 1, 8,16 and 52 weeks following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Glycaemic Variability, Measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour Period Following Exercise. This is Calculated From the Same Continuous Glucose Monitor Data as the Primary Outcome. | Measured at baseline, and 1, 8, 16 and 52 weeks following randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada | ||
| University of Alberta |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Intensity Exercise | 150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness) Exercise Training |
| FG001 | Moderate + Vigorous Intensity Exercise | 150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness) Exercise Training |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Intensity Exercise | 150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness) Exercise Training |
| BG001 | Moderate + Vigorous Intensity Exercise | 150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness) Exercise Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Spent in Hypoglycaemia in the 12-hour Period Following Exercise, Defined as an Interstitial Glucose Reading <4.0mmol/L and Measured by Continuous Glucose Monitor. | Posted | Measured at baseline, and 1, 8,16 and 52 weeks following randomization |
|
2 years
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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 | Moderate Intensity Exercise | 150-200 minutes of weekly moderate intensity exercise (45-55% of peak fitness) Exercise Training |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan McGavock | University of Manitoba | 204-480-1359 | jmcgavock@chrim.ca |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Edmonton |
| Alberta |
| T6G 2R3 |
| Canada |
| Manitoba Institute of Child Health | Winnipeg | Manitoba | R3E 3P4 | Canada |
| McMaster University | Hamilton | Ontario | L8S 4L8 | Canada |
| University of Ottawa | Ottawa | Ontario | K1N 6N5 | Canada |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Study funding not renewed; do data analyzed | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
| Secondary | Glycaemic Variability, Measured by the Mean Amplitude of Glycaemic Excursions (MAGE), in the 12-hour Period Following Exercise. This is Calculated From the Same Continuous Glucose Monitor Data as the Primary Outcome. | Not Posted | Measured at baseline, and 1, 8, 16 and 52 weeks following randomization | Participants |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Moderate + Vigorous Intensity Exercise | 150-200 minutes of weekly moderate intensity exercise, with short bouts of vigorous intensity exercise (80-90% of peak fitness) Exercise Training | 0 | 3 | 0 | 3 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |