- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hillerød, 덴마크, 3400
- 모병
- Nordsjællands Hospital
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연락하다:
- Anne Banghøj, MD
- 이메일: anne.margareta.banghoej@regionh.dk
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 대조군
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제어
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활성 비교기: CPAP treatment
Continuous Positive Airway Pressure (CPAP) treatment during three month.
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CPAP intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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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
기간: three month
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three month
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Change from start to end of 13 weeks intervention in insulin sensitivity measured by hyperinsulinemic euglycemic clamp
기간: three month
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three month
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공동 작업자 및 조사자
수사관
- 수석 연구원: Esben Laugesen, MD, Aarhus Universitets Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- DiaBOSA
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