Type 1 Diabetes Clinical Trial
Official title:
Acute Glycemic Effects of Aerobic and Resistance Exercise in Post-menopausal Women With Type 1 Diabetes
Participants will be asked to wear a continuous glucose monitor for at least three days on three separate occasions. One testing session will be a no-exercise resting control session (90 minutes). One will be a moderate aerobic exercise session (30 minutes of exercise, 60 minutes of recovery), and the third will be a moderate weight-lifting session (~30 minutes of exercise, 60 minutes of recovery).The investigators will measure changes in blood glucose during exercise by drawing blood during and after exercise. Post-exercise glucose trends will be examined using continuous glucose monitoring.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 45 Years to 75 Years |
Eligibility | Inclusion Criteria: - type 1 diabetes, diagnosed for at least one year - post-menopause (at least one year since last menstrual period), or have had a hysterectomy and bilateral salpingo oophorectomy - able to perform aerobic and resistance exercise - able to visit the lab in Edmonton, Alberta (University of Alberta) Exclusion Criteria: - HbA1c > 9.9 % - frequent and unpredictable hypoglycemia - change in insulin management strategy within the last 2 months - blood pressure > 140 / 95 - severe peripheral neuropathy - history of cardiovascular disease - musculoskeletal injuries interfering with exercise performance - use of medications (other than insulin) that affect glucose metabolism - BMI > 30 kg/m2 - smoking - moderate to high alcohol intake (> 2 drinks/day) |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Diabetes Institute | Edmonton | Alberta |
Canada | Institut de recherches cliniques de Montréal | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Women and Children's Health Research Institute, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood glucose | Change in blood glucose | From 0 minutes to 45 minutes (beginning to the end of exercise/control) and then for 60 minutes after exercise | |
Secondary | mean continuous glucose monitoring (CGM) glucose | mean of all measurements over the selected time frames | 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise | |
Secondary | coefficient of variation (CV) of CGM glucose | CV of CGM glucose over the selected time frames | 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise | |
Secondary | standard deviation (SD) | SD of CGM glucose over the selected time frames | 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise | |
Secondary | frequency of hypoglycemia | number of times that CGM glucose is equal to or less than 3.9 mmol/L | 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise | |
Secondary | frequency of hyperglycemia | number of times that CGM glucose is equal to or greater than 10.0 mmol/L | 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise | |
Secondary | percent time spent in hyperglycemia | percentage of time spent with CGM glucose equal to or greater than 10.0 mmol/L | 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise | |
Secondary | percent time spent in hypoglycemia | percentage of time spent with CGM glucose equal to or lower than 3.9 mmol/L | 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise | |
Secondary | percent time spent in range | percent of time spent with CGM glucose between 4.0 and 9.9 mmol/L | 6 hours, 12 hours, nocturnal (midnight to 6am) and 24 hours post-exercise | |
Secondary | carbohydrate supplementation | grams of carbohydrate provided during exercise to prevent hypoglycemia | from 0 minutes to 45 minutes (during exercise) |
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