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

July 28, 2010 updated by: 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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All Chinese subjects with type 2 diabetes mellitus being followed up at the diabetic clinic of a University affiliated hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
severity of OSA
Time Frame: 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
measured at a single time point during the recruitment period(2007-08), by polysomnography
glycemic control
Time Frame: measured at a single time point, when the subjects were admitted for polysomnography (during 2007-08)
by measuring glycosylated hemoglobin, blood glucose level
measured at a single time point, when the subjects were admitted for polysomnography (during 2007-08)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: David CL Lam, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

July 28, 2010

First Posted (Estimate)

July 29, 2010

Study Record Updates

Last Update Posted (Estimate)

July 29, 2010

Last Update Submitted That Met QC Criteria

July 28, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW07-060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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