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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
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Nordsjaellands Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Diabetes Obstructive Sleep Apnea Device: CPAP Other: Control Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: CPAP treatment
Continuous Positive Airway Pressure (CPAP) treatment during three month.
Device: CPAP
CPAP intervention

Control group
Control group
Other: Control
Control




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change from start to end of 13 weeks intervention in insulin sensitivity measured by hyperinsulinemic euglycemic clamp [ Time Frame: three month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus (WHO criteria)
  • Obstructive sleep apnea defined as apnoea-hypopnoea index (AHI) > 15 diagnosed with ApneaLink+® measured within three months or less prior to visit 0.
  • Signed informed content.

Exclusion Criteria:

  • Contraindications to CPAP treatment.
  • Treatment with CPAP within the last 6 months prior to visit 1.
  • Works in a transportation-related industry
  • C-peptide < 300 pmol/l - measured less than 6 months prior to visit 0
  • HbA1c:< 7% or >10% - both exclusive - at visit 0
  • Changes in antidiabetic treatment during the last four weeks prior to visit 0.
  • Unstable bodyweight, i.e. >5% change during the last three months prior to visit 0.
  • Other sleep breathing disorder

Information from the National Library of Medicine

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


Contacts
Contact: Anne Banghøj, MD anne.margareta.banghoej@regionh.dk

Locations
Denmark
Nordsjællands hospital Recruiting
Hillerød, Denmark, 3400
Contact: Anne Banghøj, MD       anne.margareta.banghoej@regionh.dk   
Sponsors and Collaborators
Nordsjaellands Hospital
Aarhus University Hospital
Investigators
Principal Investigator: Esben Laugesen, MD Aarhus Universitets Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT02482584     History of Changes
Other Study ID Numbers: DiaBOSA
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases