- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Hillerød, Danmark, 3400
- Rekruttering
- Nordsjællands Hospital
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Kontakt:
- Anne Banghøj, MD
- E-mail: anne.margareta.banghoej@regionh.dk
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: Kontrolgruppe
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Styring
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Aktiv komparator: CPAP treatment
Continuous Positive Airway Pressure (CPAP) treatment during three month.
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CPAP intervention
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in arterial stiffness measured by office carotid-femoral pulse wave velocity (cf-PWV) from start to end of 12 weeks intervention
Tidsramme: three month
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three month
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from start to end of 13 weeks intervention in insulin sensitivity measured by hyperinsulinemic euglycemic clamp
Tidsramme: three month
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three month
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Esben Laugesen, MD, Aarhus Universitets Hospital
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DiaBOSA
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