- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02482584
Impact of CPAP Treatment on Arterial Stiffness in Patients With T2DM and Newly Diagnosed Obstructive Sleep Apnoea
DiaBOSA: Impact of CPAP Treatment on Arterial Stiffness in Patients With Type 2 Diabetes and Newly Diagnosed Obstructive Sleep Apnoea
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anne Banghøj, MD
- Email: anne.margareta.banghoej@regionh.dk
Study Locations
-
-
-
Hillerød, Denmark, 3400
- Recruiting
- Nordsjællands Hospital
-
Contact:
- Anne Banghøj, MD
- Email: anne.margareta.banghoej@regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control group
|
Control
|
Active Comparator: CPAP treatment
Continuous Positive Airway Pressure (CPAP) treatment during three month.
|
CPAP intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
three month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from start to end of 13 weeks intervention in insulin sensitivity measured by hyperinsulinemic euglycemic clamp
Time Frame: three month
|
three month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Esben Laugesen, MD, Aarhus Universitets Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DiaBOSA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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