Christoffer Krogager - DiaBOSA: Impact of CPAP treatment on arterial stiffness in patients with type 2 diabetes and newly diagnosed obstructive sleep apnoea

Background: Type 2 diabetic patients have a significantly reduced life expectancy compared to non-diabetics, primarily due to a markedly increased risk of cardiovascular (CV) events. New effective preventive treatment strategies are highly needed. The arteries in diabetic patients are significantly stiffer than in non-diabetics, and there is evidence that this significantly contributes to the increased CV risk.

Diabetic patients with obstructive sleep apnoea (OSA), i.e. recurrent episodes of apnoea during sleep, are at particular high risk for CV events and have stiffer arteries than diabetics without OSA. OSA affects up to 40% of diabetics. OSA can be alleviated with Continuous Positive Airway Pressure (CPAP) treatment. It remains unknown whether CPAP treatment can reduce arterial stiffness in diabetes patients and thereby potentially contribute to reduce the cardiovascular risk.

Objective: To investigate the effects of three months’ treatment with a CPAP-device versus sham CPAP on change in arterial stiffness in T2D patients with newly detected OSA.

Design: Double blind, randomised, placebo-controlled, multicentre study of intervention with CPAP treatment versus sham CPAP. The treatment period is three months with a subsequent 9 months open extension.

Patient population: 70 patients with T2D and newly diagnosed OSA recruited from Nordsjællands Hospital, Gentofte University Hospital, Aarhus University Hospital Nørrebrogade and Silkeborg Sygehus.

Intervention: CPAP treatment versus sham CPAP.

Primary endpoint: Change in arterial stiffness measured by office carotid-femoral pulse wave velocity (cf-PWV)

Secondary endpoints:24-h cf-PWV, Office and 24-h central blood pressure,, Endothelial function assessed by the augmentation index and biomarkers, Autonomic function assessed by passive and active tests.