Metabolic Disturbance Clinical Trial
Official title:
The Influence of Different At-home Exercise Strategies on 24h Glycemic Control in Women at Risk for With Metabolic Disease
| NCT number | NCT05490706 |
| Other study ID # | 42756-2 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 7, 2022 |
| Est. completion date | April 30, 2023 |
| Verified date | May 2023 |
| Source | University of Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will determine how different at-home exercise strategies influence 24hr glycemic control in women with metabolic dysfunction.
| Status | Completed |
| Enrollment | 107 |
| Est. completion date | April 30, 2023 |
| Est. primary completion date | April 30, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 50 Years and older |
| Eligibility | Inclusion Criteria: - Females - no cancer history - =50 years old - Have metabolic dysfunction (defined as self-reported diagnosis of pre-diabetes, type 2 diabetes, or at least moderate Canadian diabetes risk (CANRISK) score) - Owns a smartphone with Bluetooth capability with Apple or Android operating system - deemed safe to exercise as per the CSEP Get Active Questionnaire - Enrolled in NCT05454943 Exclusion Criteria: - Type 1 diabetes - Taking exogenous insulin, sulfonylureas, or GLP-1 receptor agonists - Self-reported history of an eating disorder - BMI <18.5 kg/m - Working night or rotating shifts - Eating window <12 hours or consistently eating less than 3 meals/day in the past 3 months - Major dietary changes within the past 3 months (i.e. calorie counting, ketogenic diet) |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Toronto | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| University of Toronto |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 24hr Glucose area under the curve | Glucose area under the curve over 24hr | 24 hours | |
| Secondary | 24hr Average glucose concentration | Average glucose concentration over 24 hr | 24 hours | |
| Secondary | Postprandial dinner glucose response | Measured as the 2hr postprandial glucose incremental area under the curve (iAUC), average glucose and peak glucose | 2 hours | |
| Secondary | Postprandial breakfast glucose response | Measured as the 2hr postprandial iAUC, average glucose and peak glucose | 2 hours | |
| Secondary | Postprandial lunch glucose response | Measured as the 2hr postprandial glucose iAUC, average glucose and peak glucose | 2 hours | |
| Secondary | Nocturnal glucose | Measured as the overnight glucose average and AUC | ~6-8 hours | |
| Secondary | Time in hyperglycemia | Time (minutes and percent per day) above 10mmol/L over 24hr | 24 hours | |
| Secondary | Time in hypoglycemia | Time (minutes and percent per day) under 3.9mmol/L over 24 hr | 24 hours | |
| Secondary | Time in range | Time (minutes and percent per day) above 3.9 but under 10mmol/L | 24 hours | |
| Secondary | Continuous overall net glycemic action (CONGA) | Calculated measure of glycemic variability | 24 hours | |
| Secondary | Change in glucose during exercise | Post vs. pre glucose concentration around exercise | 15-30 minutes | |
| Secondary | Mean amplitude glycemic excursion (MAGE) | Calculated measure of glycemic variability | 24 hours | |
| Secondary | Standard deviation (SD) | Calculated measure of glycemic variability | 24 hours | |
| Secondary | % coefficient of variation (CV) | Calculated measure of glycemic variability | 24 hours |
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