A Study on the Prevalence of Obstructive Sleep Apnea in Patients With Type II Diabetes Mellitus
2010年7月28日 更新者：The University of Hong Kong
Prevalence and Recognition of Obstructive Sleep Apnea in Chinese With Type 2 Diabetes Mellitus
OSA is prevalent among patients with type II DM
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
177
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Hong Kong、香港、852
- Queen Mary Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
All Chinese subjects with type 2 diabetes mellitus being followed up at the diabetic clinic of a University affiliated hospital
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：横截面
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
presence of OSA
大体时间：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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
severity of OSA
大体时间：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
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glycemic control
大体时间：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
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measured at a single time point, when the subjects were admitted for polysomnography (during 2007-08)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：David CL Lam, PhD、The University of Hong Kong
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年1月1日
初级完成 (实际的)
2008年6月1日
研究完成 (实际的)
2008年12月1日
研究注册日期
首次提交
2010年7月27日
首先提交符合 QC 标准的
2010年7月28日
首次发布 (估计)
2010年7月29日
研究记录更新
最后更新发布 (估计)
2010年7月29日
上次提交的符合 QC 标准的更新
2010年7月28日
最后验证
2010年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.