ExerciseNCT05144490
The Effect of Brief Bodyweight Exercise on Acute Glycemic Control in Healthy Inactive Adults
A study testing Exercise in people with Exercise, run by McMaster University at 1 site in Canada.
Trial summary
This study will investigate whether an 11-minute bodyweight exercise session can improve short-term glycemic control. Glycemic control refers to the process of how the body regulates blood sugar. The process can be measured in different ways. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 6 Dec 2021to 30 Jun 2022
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inactive, defined as not meeting the physical activity targets in the Canadian 24-Hour Movement Guidelines for Adults.
- Deemed able to safely participate in physical activity and exercise, as determined by the Canadian Society for Exercise Physiology (CSEP) Get Active Questionnaire prescreening tool.
Who cannot join
- Experiencing a condition that might preclude safe participation in physical activity and exercise, as determined by answering "Yes" to any question on Page 1 of the CSEP Get Active Questionnaire.
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate whether an 11-minute bodyweight exercise session can improve short-term glycemic control. Glycemic control refers to the process of how the body regulates blood sugar. The process can be measured in different ways. This study will use a small device called a continuous glucose monitor to measure changes in glucose levels over a 24-hour period. Participants will complete two trials and the investigators will compare glycemic control after the exercise session and a control period that does not involve exercise. Food intake will be controlled such that each participant will consume the same diet in both conditions. This study will help determine whether a single session of bodyweight exercise affects glycemic control.
Read the detailed description
This study will investigate whether an 11-minute bodyweight exercise session can improve short-term glycemic control. Glycemic control will be assessed using continuous glucose monitoring for 24 hours following exercise or a control condition that does not involve exercise. The exercise and control periods will be directly supervised by a study investigator. Participants will complete two trials in a randomized, crossover manner separated by 7 days. Food intake will be controlled such that each participant will consume the same diet over the 24-hour period of measurement in both conditions. Standardized meals will be provided to participants prior and following the exercise and control conditions. This study will determine whether a single session of bodyweight exercise affects glycemic control as primarily assessed by mean 24-hour glucose.
- Conditions
- Exercise
- Being tested
- Exercise
- Keywords
- Glycemic Control
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
A single session of bodyweight exercise
| Study group | Role | What they receive |
|---|---|---|
| Bodyweight Exercise | Experimental | A standardized 11-minute bodyweight exercise session that involves a 1-minute warm-up followed by 5, 1-minute bouts of exercise at a self-selected "challenging" pace, interspersed with 1-minute periods of low-intensity exercise for recovery. Receives: Other: Exercise |
| Non-Exercise Control | No intervention | An 11-minute period of quiet sitting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour mean glucose
Mean glucose following the bodyweight exercise or control condition
Measured: 24-hour measurement period
Secondary outcomes (3)
Glycemic variability
Variability in glucose measured following exercise or control
Measured: 24-hour measurement period
Peak glucose
Peak glucose measured after each meal following exercise or control
Measured: 2-hour measurement period after each meal
2-hour postprandial mean glucose
Mean glucose measured after each meal following exercise or control
Measured: 2-hour measurement period after each meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start6 Dec 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- York University
- Responsible party
- Principal investigator, Martin Gibala, McMaster University
- Investigators
- Martin Gibala, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144490
- Sponsor's protocol ID
- 13864
- Status last verified
- Jul 2022
- First submitted
- 22 Nov 2021
- Last updated
- 12 Jul 2022
- 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Brief Bodyweight Exercise on Acute Glycemic Control in Healthy Inactive Adults
- ClinicalTrials.gov ID
- NCT05144490
- Acronym / sponsor ID
- 13864
- Conditions
- Exercise
- Keywords
- Glycemic Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- York University
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 3 Dec 2021 (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 investigate whether an 11-minute bodyweight exercise session can improve short-term glycemic control. Glycemic control refers to the process of how the body regulates blood sugar. The process can be measured in different ways. This study will use a small device called a continuous glucose monitor to measure changes in glucose levels over a 24-hour period. Participants will complete two trials and the investigators will compare glycemic control after the exercise session and a control period that does not involve exercise. Food intake will be controlled such that each participant will consume the same diet in both conditions. This study will help determine whether a single session of bodyweight exercise affects glycemic control.
Detailed description
This study will investigate whether an 11-minute bodyweight exercise session can improve short-term glycemic control. Glycemic control will be assessed using continuous glucose monitoring for 24 hours following exercise or a control condition that does not involve exercise. The exercise and control periods will be directly supervised by a study investigator. Participants will complete two trials in a randomized, crossover manner separated by 7 days. Food intake will be controlled such that each participant will consume the same diet over the 24-hour period of measurement in both conditions. Standardized meals will be provided to participants prior and following the exercise and control conditions. This study will determine whether a single session of bodyweight exercise affects glycemic control as primarily assessed by mean 24-hour glucose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bodyweight Exercise | Experimental | Other: ExerciseA standardized 11-minute bodyweight exercise session that involves a 1-minute warm-up followed by 5, 1-minute bouts of exercise at a self-selected "challenging" pace, interspersed with 1-minute periods of low-intensity exercise for recovery. |
| Non-Exercise Control | No intervention | –An 11-minute period of quiet sitting. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Inactive, defined as not meeting the physical activity targets in the Canadian 24-Hour Movement Guidelines for Adults.
- Deemed able to safely participate in physical activity and exercise, as determined by the Canadian Society for Exercise Physiology (CSEP) Get Active Questionnaire prescreening tool.
Key exclusion criteria (1 listed)
- Experiencing a condition that might preclude safe participation in physical activity and exercise, as determined by answering "Yes" to any question on Page 1 of the CSEP Get Active Questionnaire.
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 |
|---|---|---|
| ExerciseA single session of bodyweight exercise | Other | Bodyweight Exercise |
Primary outcome
24-hour mean glucose
Time frame: 24-hour measurement period
Mean glucose following the bodyweight exercise or control condition
3 secondary outcomes
Glycemic variability
Time frame: 24-hour measurement period
Peak glucose
Time frame: 2-hour measurement period after each meal
2-hour postprandial mean glucose
Time frame: 2-hour measurement period after each meal
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 12 Jul 2022.
- 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.
Martin Gibala, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Exercise, run by McMaster University 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 2 inclusion and 1 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 12 Jul 2022. 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?
24-hour mean glucose (time frame: 24-hour measurement period). 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 12 Jul 2022.