NCT05490706

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

July 29, 2022

Last Update Submit

May 12, 2023

Conditions

Keywords

womenglycemic controlexercise

Outcome Measures

Primary Outcomes (1)

  • 24hr Glucose area under the curve

    Glucose area under the curve over 24hr

    24 hours

Secondary Outcomes (13)

  • 24hr Average glucose concentration

    24 hours

  • Postprandial dinner glucose response

    2 hours

  • Postprandial breakfast glucose response

    2 hours

  • Postprandial lunch glucose response

    2 hours

  • Nocturnal glucose

    ~6-8 hours

  • +8 more secondary outcomes

Study Arms (3)

Bodyweight interval exercise

EXPERIMENTAL

Performing 15 minutes of bodyweight interval exercise after dinner

Behavioral: Bodyweight interval exercise

Walking

EXPERIMENTAL

Performing a 30 minute walk after dinner

Behavioral: Walking

Non exercise control

NO INTERVENTION

Performing no exercise after dinner

Interventions

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

Bodyweight interval exercise
WalkingBEHAVIORAL

Performing a 30 minute minute walk after dinner at home

Walking

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S1A1, Canada

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Jenna Gillen, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 8, 2022

Study Start

July 7, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

May 15, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations