- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01172093
A Study on the Prevalence of Obstructive Sleep Apnea in Patients With Type II Diabetes Mellitus
Prevalence and Recognition of Obstructive Sleep Apnea in Chinese With Type 2 Diabetes Mellitus
연구 개요
상태
상세 설명
Obstructive sleep apnea (OSA) has been reported to be common (prevalence ranged from 23-86%) in previous studies involving Caucasian diabetic patients. The investigators aim at finding out the prevalence of OSA in Chinese diabetic patients and identify the clinical predictors associated with OSA.
Recruited subjects will undergo overnight polysomnography, anthropometric measurements, blood tests including glycosylated hemoglobin, renal function, glucose level, blood pressure measurement both during the clinic visit and after admission for in-laboratory sleep study.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Hong Kong, 홍콩, 852
- Queen Mary Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients, age 18 - 75, with type 2 diabetes mellitus, including those on diet, on oral-hypoglycaemic agents or on insulin
- Patients who are able to give written consent to undergo polysomnography
Exclusion Criteria:
- Patients who are unable or unwilling to give written consent to participate in the study
- Patients with unstable medical illness or poor functional performance
- Patients with recent myocardial infarction or hospital admission for congestive heart failure or cardiac arrhythmia in the past three months
- Patients on renal replacement therapy for diabetic nephropathy or chronic renal failure, or plan to start renal replacement therapy in the coming six months
- Patients suffered from recent stroke in the past six months or previous history of stroke with significant focal neurological deficit
- Patients with type I diabetes
- Pregnant lady or lactating women
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 전용
- 시간 관점: 단면
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
presence of OSA
기간: measured at a single time point during the recruitment period(2007-08), by polysomnography
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The diagnosis of OSA will be confirmed with polysomnography
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measured at a single time point during the recruitment period(2007-08), by polysomnography
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
severity of OSA
기간: measured at a single time point during the recruitment period(2007-08), by polysomnography
|
The severity of OSA will be assessed in terms of apnea hypopnea index, minimal oxygen saturation, duration of desaturation, arousal index during polysomnography
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measured at a single time point during the recruitment period(2007-08), by polysomnography
|
|
glycemic control
기간: measured at a single time point, when the subjects were admitted for polysomnography (during 2007-08)
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by measuring glycosylated hemoglobin, blood glucose level
|
measured at a single time point, when the subjects were admitted for polysomnography (during 2007-08)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: David CL Lam, PhD, The University of Hong Kong
간행물 및 유용한 링크
일반 간행물
- Aronsohn RS, Whitmore H, Van Cauter E, Tasali E. Impact of untreated obstructive sleep apnea on glucose control in type 2 diabetes. Am J Respir Crit Care Med. 2010 Mar 1;181(5):507-13. doi: 10.1164/rccm.200909-1423OC. Epub 2009 Dec 17.
- Elmasry A, Lindberg E, Berne C, Janson C, Gislason T, Awad Tageldin M, Boman G. Sleep-disordered breathing and glucose metabolism in hypertensive men: a population-based study. J Intern Med. 2001 Feb;249(2):153-61. doi: 10.1046/j.1365-2796.2001.00787.x.
- Resnick HE, Redline S, Shahar E, Gilpin A, Newman A, Walter R, Ewy GA, Howard BV, Punjabi NM; Sleep Heart Health Study. Diabetes and sleep disturbances: findings from the Sleep Heart Health Study. Diabetes Care. 2003 Mar;26(3):702-9. doi: 10.2337/diacare.26.3.702.
- West SD, Nicoll DJ, Stradling JR. Prevalence of obstructive sleep apnoea in men with type 2 diabetes. Thorax. 2006 Nov;61(11):945-50. doi: 10.1136/thx.2005.057745. Epub 2006 Aug 23.
- Ronksley PE, Hemmelgarn BR, Heitman SJ, Hanly PJ, Faris PD, Quan H, Tsai WH. Obstructive sleep apnoea is associated with diabetes in sleepy subjects. Thorax. 2009 Oct;64(10):834-9. doi: 10.1136/thx.2009.115105. Epub 2009 Aug 12.
- Foster GD, Sanders MH, Millman R, Zammit G, Borradaile KE, Newman AB, Wadden TA, Kelley D, Wing RR, Sunyer FX, Darcey V, Kuna ST; Sleep AHEAD Research Group. Obstructive sleep apnea among obese patients with type 2 diabetes. Diabetes Care. 2009 Jun;32(6):1017-9. doi: 10.2337/dc08-1776. Epub 2009 Mar 11.
- Lam DC, Lui MM, Lam JC, Ong LH, Lam KS, Ip MS. Prevalence and recognition of obstructive sleep apnea in Chinese patients with type 2 diabetes mellitus. Chest. 2010 Nov;138(5):1101-7. doi: 10.1378/chest.10-0596. Epub 2010 Aug 12.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- UW07-060
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