A Study on the Prevalence of Obstructive Sleep Apnea in Patients With Type II Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

Prevalence and Recognition of Obstructive Sleep Apnea in Chinese With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172093
• Other study ID #: UW07-060
• Status: Completed
• Phase: N/A
• First received: July 27, 2010
• Last updated: July 28, 2010
• Start date: January 2007
• Est. completion date: December 2008

Study information

• Verified date: July 2010
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Observational

Clinical Trial Summary

OSA is prevalent among patients with type II DM

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Apnea
• Diabetes Mellitus
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

West SD, Nicoll DJ, Stradling JR. Prevalence of obstructive sleep apnoea in men with type 2 diabetes. Thorax. 2006 Nov;61(11):945-50. Epub 2006 Aug 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of OSA	The diagnosis of OSA will be confirmed with polysomnography	measured at a single time point during the recruitment period(2007-08), by polysomnography	No
Secondary	severity of OSA	The severity of OSA will be assessed in terms of apnea hypopnea index, minimal oxygen saturation, duration of desaturation, arousal index during polysomnography	measured at a single time point during the recruitment period(2007-08), by polysomnography	No
Secondary	glycemic control	by measuring glycosylated hemoglobin, blood glucose level	measured at a single time point, when the subjects were admitted for polysomnography (during 2007-08)	No