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Completed

NCT Number: NCT05490706

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

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

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Toronto

Toronto, Ontario, M5S1A1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bodyweight interval exercise

Behavioral

Performing 15 minutes of bodyweight interval exercise after dinner at home by following a video

Walking

Behavioral

Performing a 30 minute minute walk after dinner at home

Primary outcomes

  1. 24hr Glucose area under the curve

    Time frame: 24 hours

    Glucose area under the curve over 24hr

Secondary outcomes

  1. 24hr Average glucose concentration

    Time frame: 24 hours

    Average glucose concentration over 24 hr

  2. Postprandial dinner glucose response

    Time frame: 2 hours

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

  3. Postprandial breakfast glucose response

    Time frame: 2 hours

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

  4. Postprandial lunch glucose response

    Time frame: 2 hours

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

  5. Nocturnal glucose

    Time frame: ~6-8 hours

    Measured as the overnight glucose average and AUC

  6. Time in hyperglycemia

    Time frame: 24 hours

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

  7. Time in hypoglycemia

    Time frame: 24 hours

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

  8. Time in range

    Time frame: 24 hours

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

  9. Continuous overall net glycemic action (CONGA)

    Time frame: 24 hours

    Calculated measure of glycemic variability

  10. Change in glucose during exercise

    Time frame: 15-30 minutes

    Post vs. pre glucose concentration around exercise

  11. Mean amplitude glycemic excursion (MAGE)

    Time frame: 24 hours

    Calculated measure of glycemic variability

  12. Standard deviation (SD)

    Time frame: 24 hours

    Calculated measure of glycemic variability

  13. % coefficient of variation (CV)

    Time frame: 24 hours

    Calculated measure of glycemic variability

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2022
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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