Clinical trial NCT05706298: Active Breaks in People With Type 1 Diabetes
Official title: The Effect of Interrupting Sitting With Regular Active Breaks on Glycaemia and Daily Insulin Dose in Sedentary People With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: TREATMENT

Brief summary: the investigators aim to determine the effect of 4 weeks of frequent active breaks from prolonged sitting on time in target glycaemic range in people with type 1 diabetes with high habitual sedentary behaviour.

Detailed description: An open-label randomised controlled trial, whereby participants will complete pre-randomisation baseline procedures before allocation to 4wks of habitual activity (control) or active breaks. Interstitial glucose concentrations (fGM), insulin dose and physical activity/ postural transitions (ActivPAL) will be monitored throughout. To improve generalisability and feasibility of recruiting the required number of participants, the study will be completed in a free-living environment using remote data collection methods.

Eligibility criteria: Inclusion Criteria:

* T1D diagnosis more than 3 years ago
* Sedentary (\> 10h per waking day sedentary (sitting or lying)
* Using insulin therapy with multiple daily injections or insulin pump
* Aged 18-66 (UK retirement age)
* Use of Abbot FreeStyle Libre 2 fGM (\>6 weeks to avoid potential lifestyle changes as a result of sensor use)

Exclusion Criteria:

* Engaged in structured planned exercise (e.g. running, cycling, gym, or sports)
* Pregnancy or planning to become pregnant
* \<6 months postpartum or stopped breastfeeding \<1 month before recruitment
* Existing cerebrovascular or cardiovascular disease
* Significant history of hyperglycaemia (HbA1c \>85 mmol/mol)
* History of severe hypoglycaemia requiring third party assistance within the last 3 months

Primary outcomes:
measure: Change in time in target glycaemic range
timeFrame: change from baseline to final week of the intervention
Secondary outcomes:
measure: Change in glycaemic variability (coefficient of variation)
timeFrame: change from baseline to final week of the intervention
measure: Change in insulin dose
timeFrame: change from baseline to final week of the intervention
measure: Change in Concentration of Hba1c
timeFrame: change from baseline to post intervention (4 weeks)
measure: Change Insulin to CHO ratio
timeFrame: change from baseline to post intervention (4 weeks)
measure: Change in Anxiety and depression
timeFrame: change from baseline to post intervention (4 weeks)
measure: Change in Diabetes Quality of Life
timeFrame: change from baseline to post intervention (4 weeks)
measure: Change in Health-related quality of life
timeFrame: change from baseline to post intervention (4 weeks)
measure: Change in Height
timeFrame: change from baseline to post intervention (4 weeks)
measure: Change in weight
timeFrame: change from baseline to post intervention (4 weeks)
measure: Change in BMI
timeFrame: change from baseline to post intervention (4 weeks)
measure: Change in waist circumference
timeFrame: change from baseline to post intervention (4 weeks)
measure: Change in triglycerides.
timeFrame: change from baseline to post intervention (4 weeks)
measure: Change in Insulin Sensitivity Score
timeFrame: change from baseline to post intervention (4 weeks)
measure: c-peptide
timeFrame: baseline
measure: Change in sedentary behaviour
timeFrame: change from baseline to final week of the intervention
measure: Change in carbohydrate intake
timeFrame: change from baseline to final week of the intervention
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool John Moores University
Study officials:
References: