MOReS Freestyle Libre Validation Study

Cognitive Change Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04989712
• Other study ID #: LGHC072021
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2021
• Est. completion date: September 2024

Study information

• Verified date: November 2023
• Source: Oxford Brookes University
• Contact: Shelly Coe, PhD
• Phone: +441865483839
• Email: scoe[@]brookes.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Blood Glucose
• Cognitive Change
• Executive Function

Intervention

Other:
• Exposure
Participants randomised to one of the three exposures

Locations

Country	Name	City	State
United Kingdom	Oxford Brookes University	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Oxford Brookes University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Maximum of two weeks
Primary	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.	Maximum of two weeks
Secondary	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.	Maximum of two weeks