Blood GlucoseNCT04989712
MOReS Freestyle Libre Validation Study
A study testing Exposure in people with Blood Glucose and Executive Function, run by Oxford Brookes University at 1 site in United Kingdom.
Trial summary
To measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on physical and cognitive performance, health and wellbeing in young people. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose, Executive Function, Cognitive Change
- What is being tested?
- Exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2021to Sep 2024
- 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 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Young people aged 9-18 years old
- No significant current or previous medical history
- Are able to participate safely in the study's assessments and brief interrupted sitting moderate to vigorous physical activity (MVPA)
Who cannot join
- Those with uncontrolled epilepsy/seizures (stable epilepsy/on medication > 12 weeks)
- Those who have Type 1 and Type 2 diabetes or other glucose intolerance or on medication for such conditions
- Those who experience contraindications to physical training
- Those who are on any form of steroids, anti-anxiety/depression drugs, birth control, beta-blockers, statin, adrenaline, HIV or Hepatitis C medications (these medications can affect the readings during the oral glucose tolerance test)
- Those with known allergies to plasters
Trial locations and contacts
1 site in 1 country.
Jo Cossington, BSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford Brookes University
Oxford, Oxfordshire, OX3 0BP
Shelly Coe, PhD, scoe@brookes.ac.uk
About this study
Official title: The Impact of Different Exercise Timings on Blood Glucose Control and Cognition in Children and Adolescents Using the Freestyle Libre Continuous Glucose Monitoring System
To measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on physical and cognitive performance, health and wellbeing in young people.
Read the detailed description
Cross over randomised exposure response experimental study in 10 healthy children and adolescents, to measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on their physical and cognitive performance, mobility, health and wellbeing. The study will assess the extent of the immediate and short-term effects of interrupting sitting with brief moderate-vigorous physical activity (MVPA) breaks compared to a sitting only condition.
Dietary analysis and metabolic and cognitive tests after acute exercise will be performed on the participants to compare the FreeStyle Libre responses between those with and without disabilities.
- Conditions
- Blood Glucose, Executive Function, Cognitive Change
- Being tested
- Exposure
- Keywords
- MVPA, Glucose, Cognition, Children, Adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposureOther
Participants randomised to one of the three exposures
| Study group | Role | What they receive |
|---|---|---|
| 20 minutes MVPA | Experimental | 20 minutes of moderate to vigorous exercise at 50-80% maximum heart rate to be performed on a cycle ergometer 40 minutes from the start of the testing session following consumption of a glucose solution at 0 mins. Glucose readings from the FreeStyle Libre to be taken at 0 mins, 30 mins, 60 mins, 90 mins and 120 mins. Cognitive tests to be carried out before the glucose solution is administered at 0 mins and at the 120 min point. Receives: Other: Exposure |
| 4 x 5 mins MVPA | Experimental | 4 bouts of 5 minutes of moderate to vigorous exercise at 50-80% maximum heart rate to be performed on a cycle ergometer 30 minutes from the start of the testing session and repeated at 60 mins, 90 mins and 120 mins following consumption of a glucose solution at 0 mins. Glucose readings from the FreeStyle Libre to be taken at 0 mins, 30 mins, 60 mins, 90 mins and 120 mins. Cognitive tests to be carried out before the glucose solution is administered at 0 mins and at the 120 min point. Receives: Other: Exposure |
| Uninterrupted sitting - No exercise, sitting session (control). | Experimental | A sitting only exposure, glucose solution to be consumed at 0 mins.Glucose readings from the FreeStyle Libre to be taken at 0 mins, 30 mins, 60 mins, 90 mins and 120 mins. Cognitive tests to be carried out before the glucose solution is administered at 0 mins and at the 120 min point Receives: Other: Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Functioning - Eriksen Flanker Task
The main outcome will be change in executive functioning from the start to the end of the session using the Eriksen Flanker Task. The test measures selective attention and executive control and measures speed (milliseconds) and accuracy (number of responses correct). This will be performed before the oral glucose tolerance test and again at the end of each session.
Measured: Maximum of two weeks
Working Memory - WISC Digit Span
Wechsler Intelligence Scale for Children (WISC) Digit Span will test attention and working memory. The total score is calculated by the number of correct responses. This will be performed before the oral glucose tolerance test and again at the end of each session.
Measured: Maximum of two weeks
Secondary outcomes (1)
Oral Glucose Tolerance Test (OGTT)
On arrival an OGTT, simulating insulin and glucose response comparable to that following a meal will be given. Children will follow an identical protocol for OGTT during all conditions. Children will be asked to fast the night before, for 10 hours prior to the test. They will arrive fasted, have a baseline glucose reading taken and will be given the OGTT, followed by sit only or sit in addition to physical activity breaks regimens. For the OGTT the stimulus is 1.75g/kg body weight of glucose solution. A Freestyle Libre glucose monitoring system will be placed on the participants' arm and glucose readings will be monitored at timed intervals.
Measured: Maximum of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start28 Oct 2021
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood GlucoseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised cross over design. Participants act as own controls.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shelly Coe, Oxford Brookes University
- Investigators
- Helen Dawes, PhD, Principal investigator, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989712
- Sponsor's protocol ID
- LGHC072021
- Status last verified
- Nov 2023
- First submitted
- 13 Jul 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Exercise Timings on Blood Glucose Control and Cognition in Children and Adolescents Using the Freestyle Libre Continuous Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT04989712
- Acronym / sponsor ID
- LGHC072021
- Conditions
- Blood Glucose, Executive Function, Cognitive Change
- Keywords
- MVPA, Glucose, Cognition, Children, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 4 Aug 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.
To measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on physical and cognitive performance, health and wellbeing in young people.
Detailed description
Cross over randomised exposure response experimental study in 10 healthy children and adolescents, to measure the effects of interrupting prolonged sitting with brief standing physical activity interventions on their physical and cognitive performance, mobility, health and wellbeing. The study will assess the extent of the immediate and short-term effects of interrupting sitting with brief moderate-vigorous physical activity (MVPA) breaks compared to a sitting only condition.
Dietary analysis and metabolic and cognitive tests after acute exercise will be performed on the participants to compare the FreeStyle Libre responses between those with and without disabilities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised cross over design. Participants act as own controls.
| Arm | Type | Receives |
|---|---|---|
| 20 minutes MVPA | Experimental | Other: Exposure20 minutes of moderate to vigorous exercise at 50-80% maximum heart rate to be performed on a cycle ergometer 40 minutes from the start of the testing session following consumption of a glucose solution at 0 mins. Glucose readings from the FreeStyle Libre to be taken at 0 mins, 30 mins, 60 mins, 90 mins and 120 mins. Cognitive tests to be carried out before the glucose solution is administered at 0 mins and at the 120 min point. |
| 4 x 5 mins MVPA | Experimental | Other: Exposure4 bouts of 5 minutes of moderate to vigorous exercise at 50-80% maximum heart rate to be performed on a cycle ergometer 30 minutes from the start of the testing session and repeated at 60 mins, 90 mins and 120 mins following consumption of a glucose solution at 0 mins. Glucose readings from the FreeStyle Libre to be taken at 0 mins, 30 mins, 60 mins, 90 mins and 120 mins. Cognitive tests to be carried out before the glucose solution is administered at 0 mins and at the 120 min point. |
| Uninterrupted sitting - No exercise, sitting session (control). | Experimental | Other: ExposureA sitting only exposure, glucose solution to be consumed at 0 mins.Glucose readings from the FreeStyle Libre to be taken at 0 mins, 30 mins, 60 mins, 90 mins and 120 mins. Cognitive tests to be carried out before the glucose solution is administered at 0 mins and at the 120 min point |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Young people aged 9-18 years old
- No significant current or previous medical history
- Are able to participate safely in the study's assessments and brief interrupted sitting moderate to vigorous physical activity (MVPA)
Key exclusion criteria (5 listed)
- Those with uncontrolled epilepsy/seizures (stable epilepsy/on medication > 12 weeks)
- Those who have Type 1 and Type 2 diabetes or other glucose intolerance or on medication for such conditions
- Those who experience contraindications to physical training
- Those who are on any form of steroids, anti-anxiety/depression drugs, birth control, beta-blockers, statin, adrenaline, HIV or Hepatitis C medications (these medications can affect the readings during the oral glucose tolerance test)
- Those with known allergies to plasters
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 |
|---|---|---|
| ExposureParticipants randomised to one of the three exposures | Other | 20 minutes MVPA, 4 x 5 mins MVPA, Uninterrupted sitting - No exercise, sitting session (control). |
Primary outcome
Executive Functioning - Eriksen Flanker Task
Time frame: Maximum of two weeks
The main outcome will be change in executive functioning from the start to the end of the session using the Eriksen Flanker Task. The test measures selective attention and executive control and measures speed (milliseconds) and accuracy (number of responses correct). This will be performed before the oral glucose tolerance test and again at the end of each session.
Working Memory - WISC Digit Span
Time frame: Maximum of two weeks
Wechsler Intelligence Scale for Children (WISC) Digit Span will test attention and working memory. The total score is calculated by the number of correct responses. This will be performed before the oral glucose tolerance test and again at the end of each session.
1 secondary outcome
Oral Glucose Tolerance Test (OGTT)
Time frame: Maximum of two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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.
Jo Cossington, BSc contact
Helen Dawes, PhD principal investigator
Oxford Brookes 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 Exposure in people with Blood Glucose and Executive Function, run by Oxford Brookes University at 1 site in United Kingdom.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Nov 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shelly Coe, PhD (+441865483839, scoe@brookes.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Functioning - Eriksen Flanker Task (time frame: Maximum of two weeks). The study lists 2 primary outcomes in all. 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 18 Nov 2023.