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

The Influence of Different At-home Exercise Strategies on 24h Glycemic Control in Women at Risk for With Metabolic Disease

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

Study Overview

• Status: Completed
• Conditions: Metabolic Disturbance
• Intervention / Treatment: Behavioral: Bodyweight interval exercise; Behavioral: Walking

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 Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S1A1
      • University of Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bodyweight interval exercise; Performing 15 minutes of bodyweight interval exercise after dinner	Behavioral: Bodyweight interval exercise; Performing 15 minutes of bodyweight interval exercise after dinner at home by following a video
Experimental: Walking; Performing a 30 minute walk after dinner	Behavioral: Walking; Performing a 30 minute minute walk after dinner at home
No Intervention: Non exercise control; Performing no exercise after dinner

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24hr Glucose area under the curve	Glucose area under the curve over 24hr	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Toronto
• Investigators: Principal Investigator: Jenna Gillen, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: exercise; women; glycemic control
• Other Study ID Numbers: 42756-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No