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

Completed

• Conditions: Diabetes Mellitus; Obstructive Sleep Apnea

• Registration Number: NCT01172093
• Lead Sponsor: The University of Hong Kong

Brief Summary

OSA is prevalent among patients with type II DM

Detailed 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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-06
• Study Completion: 2008-12
• Status Verified: 2010-07
• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-07-28
• Last Update Submitted: 2010-07-28
• Study First Posted: 2010-07-29
• Last Update Posted: 2010-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
presence of OSA	measured at a single time point during the recruitment period(2007-08), by polysomnography	The diagnosis of OSA will be confirmed with polysomnography

Secondary Outcome Measures

Name	Time	Method
severity of OSA	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
glycemic control	measured at a single time point, when the subjects were admitted for polysomnography (during 2007-08)	by measuring glycosylated hemoglobin, blood glucose level

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong