Impact of CPAP Treatment on Arterial Stiffness in Patients With T2DM and Newly Diagnosed Obstructive Sleep Apnoea
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|ClinicalTrials.gov Identifier: NCT02482584|
Recruitment Status : Unknown
Verified November 2016 by Nordsjaellands Hospital.
Recruitment status was: Recruiting
First Posted : June 26, 2015
Last Update Posted : March 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Obstructive Sleep Apnea||Device: CPAP Other: Control||Not Applicable|
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.
Primary endpoint: Change in arterial stiffness measured by office carotid-femoral pulse wave velocity (cf-PWV) from start to end of 12 weeks intervention.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||DiaBOSA: Impact of CPAP Treatment on Arterial Stiffness in Patients With Type 2 Diabetes and Newly Diagnosed Obstructive Sleep Apnoea|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||August 2018|
Active Comparator: CPAP treatment
Continuous Positive Airway Pressure (CPAP) treatment during three month.
- Change in arterial stiffness measured by office carotid-femoral pulse wave velocity (cf-PWV) from start to end of 12 weeks intervention [ Time Frame: three month ]
- Change from start to end of 13 weeks intervention in insulin sensitivity measured by hyperinsulinemic euglycemic clamp [ Time Frame: three month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482584
|Contact: Anne Banghøj, MDfirstname.lastname@example.org|
|Hillerød, Denmark, 3400|
|Contact: Anne Banghøj, MD email@example.com|
|Principal Investigator:||Esben Laugesen, MD||Aarhus Universitets Hospital|