Abstract
BackgroundObstructive sleep apnoea (OSA) is very common in patients with type 2 diabetes (T2D). We and others have shown that OSA was associated with diabetes-related microvascular complications in patients with T2D in cross-sectional and longitudinal studies and that compliance with continuous positive airway pressure (CPAP) reduced the progression of microvascular complications. Hence, we hypothesised that adequate CPAP reduces the development of microvascular complication in patients with T2D.MethodsSLEEP T2D is a cohort study with embedded feasibility, open-label, parallel-arm, randomised control trial (RCT) over 2 years. The primary aim is the feasibility of conducting a definitive RCT assessing the impact of CPAP on chronic kidney disease and other microvascular complications in patients with T2D. The main parameters are to assess willingness of participants to be randomised, follow-up rates, CPAP adherence/compliance, to optimise the choice of outcome measures for a substantive trial, and to identify the parameters for sample size calculations. The secondary aims of the study are related to the impact of CPAP, sleep-related disorders, and sleep chronotype on a variety of diabetes-related end points. The study participants were recruited from the T2D services in multiple NHS trusts across England. The main exclusion criteria for the cohort study are as follows: T1D, eGFR < 15 mL/min/1.73 m2, known OSA, active malignancy or chronic kidney disease from reasons other than diabetes, pregnancy, professional drivers, and a history of falling asleep whilst driving within last 2 years. The main exclusion criteria from the RCT were as follows: Apnoea-Hypopnoea Index < 10 and Epworth Sleepiness Score ≥ 11. Study participants were extensively phenotyped clinically and biochemically. The OSA diagnosis was based on multichannel portable device (ApneaLink AirTM, Resmed).DiscussionThe feasibility RCT will help us design the future RCT to assess the impact of CPAP on diabetes-related microvascular complications. The cohort study will generate preliminary data regarding the impact of sleep quality, duration, and chronotype on diabetes-related outcomes which could lead to further mechanistic and interventional studies.Trial registrationISRCTN, ISRCTN12361838. Registered 04 April 2018, Protocol version: v5.0 02.12.19.
Highlights
Obstructive sleep apnoea (OSA) is very common in patients with type 2 diabetes (T2D)
The feasibility randomised control trial (RCT) will help us design the future RCT to assess the impact of continuous positive airway pressure (CPAP) on diabetes-related microvascular complications
Patients with moderate to severe OSA are recommended to be treated with CPAP in the UK if they are symptomatic, if they have excessive daytime sleepiness (EDS) [50]
Summary
Obstructive sleep apnoea (OSA) is very common in patients with type 2 diabetes (T2D). We and others have shown that OSA was associated with diabetes-related microvascular complications in patients with T2D in cross-sectional and longitudinal studies and that compliance with continuous positive airway pressure (CPAP) reduced the progression of microvascular complications. Obstructive sleep apnoea and type 2 diabetes mellitus OSA is an established independent risk factor for incident type 2 diabetes (T2D) [8,9,10], and more recently T2D has been shown to be associated with increased risk of OSA compared to appropriately matched population without diabetes and after adjustments for potential confounders [11]. The severity of OSA is independently associated with worsening glycaemic control in patients with T2D [19]
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