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

• Sponsor: University of Toronto (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05490706
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metabolic Disturbance	Behavioral: Bodyweight interval exercise; Behavioral: Walking	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Influence of Different At-home Exercise Strategies on 24h Glycemic Control in Women at Risk for With Metabolic Disease
• Actual Study Start Date: Jul 7, 2022
• Anticipated Primary Completion Date: Jan 6, 2023
• Anticipated Study Completion Date: Jul 6, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 24hr Glucose area under the curve [24 hours]

   Glucose area under the curve over 24hr

Secondary Outcome Measures

1. 24hr Average glucose concentration [24 hours]

   Average glucose concentration over 24 hr

2. Postprandial dinner glucose response [2 hours]

   Measured as the 2hr postprandial glucose incremental area under the curve (iAUC), average glucose and peak glucose

3. Postprandial breakfast glucose response [2 hours]

   Measured as the 2hr postprandial iAUC, average glucose and peak glucose

4. Postprandial lunch glucose response [2 hours]

   Measured as the 2hr postprandial glucose iAUC, average glucose and peak glucose

5. Nocturnal glucose [~6-8 hours]

   Measured as the overnight glucose average and AUC

6. Time in hyperglycemia [24 hours]

   Time (minutes and percent per day) above 10mmol/L over 24hr

7. Time in hypoglycemia [24 hours]

   Time (minutes and percent per day) under 3.9mmol/L over 24 hr

8. Time in range [24 hours]

   Time (minutes and percent per day) above 3.9 but under 10mmol/L

9. Continuous overall net glycemic action (CONGA) [24 hours]

   Calculated measure of glycemic variability

10. Change in glucose during exercise [15-30 minutes]

    Post vs. pre glucose concentration around exercise

11. Mean amplitude glycemic excursion (MAGE) [24 hours]

    Calculated measure of glycemic variability

12. Standard deviation (SD) [24 hours]

    Calculated measure of glycemic variability

13. % coefficient of variation (CV) [24 hours]

    Calculated measure of glycemic variability

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Toronto	Toronto	Ontario	Canada	M5S1A1

Sponsors and Collaborators

• University of Toronto

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jenna Gillen, Assistant Professor, University of Toronto
• ClinicalTrials.gov Identifier: NCT05490706
• Other Study ID Numbers: 42756-2
• First Posted: Aug 8, 2022
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jenna Gillen, Assistant Professor, University of Toronto: women; glycemic control; exercise

Study Results

No Results Posted as of Aug 8, 2022