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Completed

NCT Number: NCT01172093

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

OSA is prevalent among patients with type II DM

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Key information

Conditions

Obstructive Sleep Apnea Apnea Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary Hospital

Hong Kong, 852

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 29, 2010
Registry last updated
Jul 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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