Clinical trial NCT05490706: The Influence of Different At-home Exercise Strategies on 24h Glycemic Control
Official title: The Influence of Different At-home Exercise Strategies on 24h Glycemic Control in Women at Risk for With Metabolic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Disturbance
Keywords: women
glycemic control
exercise
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 107
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will determine how different at-home exercise strategies influence 24hr glycemic control in women with metabolic dysfunction.

Detailed description: Elevations in blood glucose concentration increase risk for cardiometabolic diseases including type 2 diabetes and cardiovascular diseases. Exercise can improve glycemic control, but there is limited research comparing the effectiveness of different exercise strategies in women. The aim of this study is to examine, under free-living conditions, how performing either walking and bodyweight interval exercise after dinner influences glycemic control in women with or at risk for type 2 diabetes. Glycemic control will be measured with continuous glucose monitors.

Eligibility criteria: 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)

Primary outcomes:
measure: 24hr Glucose area under the curve
timeFrame: 24 hours
Secondary outcomes:
measure: 24hr Average glucose concentration
timeFrame: 24 hours
measure: Postprandial dinner glucose response
timeFrame: 2 hours
measure: Postprandial breakfast glucose response
timeFrame: 2 hours
measure: Postprandial lunch glucose response
timeFrame: 2 hours
measure: Nocturnal glucose
timeFrame: ~6-8 hours
measure: Time in hyperglycemia
timeFrame: 24 hours
measure: Time in hypoglycemia
timeFrame: 24 hours
measure: Time in range
timeFrame: 24 hours
measure: Continuous overall net glycemic action (CONGA)
timeFrame: 24 hours
measure: Change in glucose during exercise
timeFrame: 15-30 minutes
measure: Mean amplitude glycemic excursion (MAGE)
timeFrame: 24 hours
measure: Standard deviation (SD)
timeFrame: 24 hours
measure: % coefficient of variation (CV)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Jenna Gillen, PhD
role: PRINCIPAL_INVESTIGATOR
References: