Diabetes Clinical Trial
Official title:
DiaBOSA: Impact of CPAP Treatment on Arterial Stiffness in Patients With Type 2 Diabetes and Newly Diagnosed Obstructive Sleep Apnoea
The purpose of the trial is to investigate the effects of three months' treatment with a CPAP-device versus control group on change in arterial stiffness in type 2 diabetes (T2D) patients with newly detected Obstructive Sleep Apnoea (OSA).
Background: Obstructive sleep apnoea (OSA) is a common disorder characterised by recurrent
episodes of apnoea or hypopnoea during sleep. OSA is associated with excessive daytime
sleepiness and linked to increased cardiovascular morbidity and mortality. OSA can be
alleviated with Continuous Positive Airway Pressure (CPAP) treatment.
Cardiovascular disease is the major cause of decreased life expectancy, morbidity and
reduced quality of life in patients with type 2 diabetes (T2D). Increased stiffness of the
aorta has been associated with increased cardiovascular morbidity and mortality in diabetic
patients.
Previous studies have reported a much higher frequency of OSA in patients with obesity and
T2D compared with non-diabetic subjects, and found that OSA was associated with arterial
stiffness. However, whether CPAP treatment improves arterial stiffness and insulin
sensitivity in T2D patients remain to be elucidated.
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: Randomised, controlled, multicentre study of intervention with CPAP treatment versus
control group. 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 Department
of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Department of
Endocrinology, Gentofte University Hospital, Department of Endocrinology and Internal
Medicine, Aarhus University Hospital Nørrebrogade and Department of Internal Medicine,
Silkeborg Sygehus.
Intervention: CPAP treatment versus control group.
Endpoints:
Primary endpoint: Change in arterial stiffness measured by office carotid-femoral pulse wave
velocity (cf-PWV) from start to end of 12 weeks intervention.
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