Status:
COMPLETED
Non-REm Sleep inTervention to improvE Diabetes RESTED
Lead Sponsor:
University of Lincoln
Collaborating Sponsors:
University of Leeds
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Diabetes is a known risk factor for cardiovascular disease. This research aims to improve glucose metabolism in patients with T2DM thereby reducing the impact of diabetes and the subsequent risk of fu...
Detailed Description
The proposed project uses a 'crossover randomised controlled trial' design, where two different treatments are compared in all participants. Each participant will therefore receive both treatments (so...
Eligibility Criteria
Inclusion
- Able to give informed consent
- Over 18 years of age
- Diagnosed with T2DM, as defined by WHO
- Managed by diet and metformin, for at least 3 months
- Able to speak and understand English
- A regular single-phase of sleep (ie. single period of sleep per 24 hours)
- Normally wakes before 09:00 am and achieves at least 6 hours of sleep
Exclusion
- T2DM treated with any medication other than diet and metformin
- Change in regular medication during the study period
- Any other physical or psychological disease likely to interfere with the normal conduct of the study such as coeliac disease or untreated hypothyroidism
- Clinically-diagnosed Obstructive Sleep Apnoea
- Epworth Sleepiness Score above 10
- Prior history of drug, alcohol or solvent abuse
- Self-reported hearing loss or impairment
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04120571
Start Date
April 1 2019
End Date
August 1 2021
Last Update
December 11 2024
Active Locations (1)
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1
University of Lincoln
Lincoln, Lincolnshire, United Kingdom, LN6 7TS