Active Breaks in People With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— EXTOD-Active  

Official title:

The Effect of Interrupting Sitting With Regular Active Breaks on Glycaemia and Daily Insulin Dose in Sedentary People With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05706298
• Other study ID #: 22LJMUSPONSOR010
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: October 2023
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Active Breaks
Participants will be asked to interrupt sitting with 3 min bouts of walking every 30 min from 9am-5pm

Locations

Country	Name	City	State
United Kingdom	Liverpool John Moores University	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool John Moores University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in time in target glycaemic range	flash glucose monitoring	change from baseline to final week of the intervention
Secondary	Change in glycaemic variability (coefficient of variation)	flash glucose monitoring	change from baseline to final week of the intervention
Secondary	Change in insulin dose	Insulin dose	change from baseline to final week of the intervention
Secondary	Change in Concentration of Hba1c	HbA1c	change from baseline to post intervention (4 weeks)
Secondary	Change Insulin to CHO ratio	Insulin to CHO ratio	change from baseline to post intervention (4 weeks)
Secondary	Change in Anxiety and depression	The Hospital Anxiety and Depression Scale (HADS)	change from baseline to post intervention (4 weeks)
Secondary	Change in Diabetes Quality of Life	Diabetes Quality of Life (DQOL) questionnaire	change from baseline to post intervention (4 weeks)
Secondary	Change in Health-related quality of life	Short Form-12 Health Survey (SF-12)	change from baseline to post intervention (4 weeks)
Secondary	Change in Height	Height (cm)	change from baseline to post intervention (4 weeks)
Secondary	Change in weight	weight (kg)	change from baseline to post intervention (4 weeks)
Secondary	Change in BMI	BMI	change from baseline to post intervention (4 weeks)
Secondary	Change in waist circumference	waist circumference (cm)	change from baseline to post intervention (4 weeks)
Secondary	Change in triglycerides.	triglycerides.	change from baseline to post intervention (4 weeks)
Secondary	Change in Insulin Sensitivity Score	LogeIS	change from baseline to post intervention (4 weeks)
Secondary	c-peptide	c-peptide	baseline
Secondary	Change in sedentary behaviour	minutes of sitting	change from baseline to final week of the intervention
Secondary	Change in carbohydrate intake	carbohydrate intake	change from baseline to final week of the intervention