The Influence of Different At-home Exercise Strategies on 24h Glycemic Control

Not Applicable

Completed

• Conditions: Metabolic Disturbance
• Interventions: Behavioral: Bodyweight interval exercise; Behavioral: Walking

• Registration Number: NCT05490706
• Lead Sponsor: University of Toronto

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.

Study Timeline

• Study Start: 2022-07-07
• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-08
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 107

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bodyweight interval exercise	Bodyweight interval exercise	Performing 15 minutes of bodyweight interval exercise after dinner
Walking	Walking	Performing a 30 minute walk after dinner

Primary Outcome Measures

Name	Time	Method
24hr Glucose area under the curve	24 hours	Glucose area under the curve over 24hr

Secondary Outcome Measures

Name	Time	Method
24hr Average glucose concentration	24 hours	Average glucose concentration over 24 hr
Time in hyperglycemia	24 hours	Time (minutes and percent per day) above 10mmol/L over 24hr
Postprandial dinner glucose response	2 hours	Measured as the 2hr postprandial glucose incremental area under the curve (iAUC), average glucose and peak glucose
Nocturnal glucose	~6-8 hours	Measured as the overnight glucose average and AUC
Postprandial breakfast glucose response	2 hours	Measured as the 2hr postprandial iAUC, average glucose and peak glucose
Postprandial lunch glucose response	2 hours	Measured as the 2hr postprandial glucose iAUC, average glucose and peak glucose
Time in hypoglycemia	24 hours	Time (minutes and percent per day) under 3.9mmol/L over 24 hr
Time in range	24 hours	Time (minutes and percent per day) above 3.9 but under 10mmol/L
Change in glucose during exercise	15-30 minutes	Post vs. pre glucose concentration around exercise
Standard deviation (SD)	24 hours	Calculated measure of glycemic variability
Continuous overall net glycemic action (CONGA)	24 hours	Calculated measure of glycemic variability
Mean amplitude glycemic excursion (MAGE)	24 hours	Calculated measure of glycemic variability
% coefficient of variation (CV)	24 hours	Calculated measure of glycemic variability

Trial Locations

Locations (1)

University of Toronto; 🇨🇦 Toronto, Ontario, Canada