Metabolic DisturbanceNCT05490706
The Influence of Different At-home Exercise Strategies on 24h Glycemic Control
A study testing Bodyweight interval exercise and Walking in people with Metabolic Disturbance, run by University of Toronto at 1 site in Canada.
Trial summary
This study will determine how different at-home exercise strategies influence 24hr glycemic control in women with metabolic dysfunction. Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disturbance
- What is being tested?
- Bodyweight interval exercise and Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jul 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Disturbance
- Being tested
- Bodyweight interval exercise, Walking
- Keywords
- women, glycemic control, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodyweight interval exerciseBehavioural
Performing 15 minutes of bodyweight interval exercise after dinner at home by following a video
WalkingBehavioural
Performing a 30 minute minute walk after dinner at home
| Study group | Role | What they receive |
|---|---|---|
| Bodyweight interval exercise | Experimental | Performing 15 minutes of bodyweight interval exercise after dinner Receives: Behavioral: Bodyweight interval exercise |
| Walking | Experimental | Performing a 30 minute walk after dinner Receives: Behavioral: Walking |
| Non exercise control | No intervention | Performing no exercise after dinner |
What is being measured
The primary outcome is the main question the study is designed to answer.
24hr Glucose area under the curve
Glucose area under the curve over 24hr
Measured: 24 hours
Secondary outcomes (13)
24hr Average glucose concentration
Average glucose concentration over 24 hr
Measured: 24 hours
Postprandial dinner glucose response
Measured as the 2hr postprandial glucose incremental area under the curve (iAUC), average glucose and peak glucose
Measured: 2 hours
Postprandial breakfast glucose response
Measured as the 2hr postprandial iAUC, average glucose and peak glucose
Measured: 2 hours
Postprandial lunch glucose response
Measured as the 2hr postprandial glucose iAUC, average glucose and peak glucose
Measured: 2 hours
Nocturnal glucose
Measured as the overnight glucose average and AUC
Measured: ~6-8 hours
Time in hyperglycemia
Time (minutes and percent per day) above 10mmol/L over 24hr
Measured: 24 hours
Time in hypoglycemia
Time (minutes and percent per day) under 3.9mmol/L over 24 hr
Measured: 24 hours
Time in range
Time (minutes and percent per day) above 3.9 but under 10mmol/L
Measured: 24 hours
Continuous overall net glycemic action (CONGA)
Calculated measure of glycemic variability
Measured: 24 hours
Change in glucose during exercise
Post vs. pre glucose concentration around exercise
Measured: 15-30 minutes
Mean amplitude glycemic excursion (MAGE)
Calculated measure of glycemic variability
Measured: 24 hours
Standard deviation (SD)
Calculated measure of glycemic variability
Measured: 24 hours
% coefficient of variation (CV)
Calculated measure of glycemic variability
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start7 Jul 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisturbanceStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna Gillen, University of Toronto
- Investigators
- Jenna Gillen, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490706
- Sponsor's protocol ID
- 42756-2
- Status last verified
- May 2023
- First submitted
- 29 Jul 2022
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different At-home Exercise Strategies on 24h Glycemic Control in Women at Risk for With Metabolic Disease
- ClinicalTrials.gov ID
- NCT05490706
- Acronym / sponsor ID
- 42756-2
- Conditions
- Metabolic Disturbance
- Keywords
- women, glycemic control, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bodyweight interval exercise | Experimental | Behavioral: Bodyweight interval exercisePerforming 15 minutes of bodyweight interval exercise after dinner |
| Walking | Experimental | Behavioral: WalkingPerforming a 30 minute walk after dinner |
| Non exercise control | No intervention | –Performing no exercise after dinner |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bodyweight interval exercisePerforming 15 minutes of bodyweight interval exercise after dinner at home by following a video | Behavioural | Bodyweight interval exercise |
| WalkingPerforming a 30 minute minute walk after dinner at home | Behavioural | Walking |
Primary outcome
24hr Glucose area under the curve
Time frame: 24 hours
Glucose area under the curve over 24hr
13 secondary outcomes
24hr Average glucose concentration
Time frame: 24 hours
Postprandial dinner glucose response
Time frame: 2 hours
Postprandial breakfast glucose response
Time frame: 2 hours
Postprandial lunch glucose response
Time frame: 2 hours
Nocturnal glucose
Time frame: ~6-8 hours
Time in hyperglycemia
Time frame: 24 hours
Time in hypoglycemia
Time frame: 24 hours
Time in range
Time frame: 24 hours
Continuous overall net glycemic action (CONGA)
Time frame: 24 hours
Change in glucose during exercise
Time frame: 15-30 minutes
Mean amplitude glycemic excursion (MAGE)
Time frame: 24 hours
Standard deviation (SD)
Time frame: 24 hours
% coefficient of variation (CV)
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenna Gillen, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bodyweight interval exercise and Walking in people with Metabolic Disturbance, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24hr Glucose area under the curve (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2023.