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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01172093
Recruitment Status : Completed
First Posted : July 29, 2010
Last Update Posted : July 29, 2010
Information provided by:
The University of Hong Kong

Brief Summary:
OSA is prevalent among patients with type II DM

Condition or disease
Obstructive Sleep Apnea Diabetes Mellitus

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
Actual Enrollment : 177 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalence and Recognition of Obstructive Sleep Apnea in Chinese With Type 2 Diabetes Mellitus
Study Start Date : January 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  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

Biospecimen Retention:   Samples Without DNA
Plasma and serum samples were collected from subjects for batch assays for further research purposes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01172093

Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong, 852
Sponsors and Collaborators
The University of Hong Kong
Principal Investigator: David CL Lam, PhD The University of Hong Kong

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Professor Ip Sau Man Mary, The University of Hong Kong Identifier: NCT01172093     History of Changes
Other Study ID Numbers: UW07-060
First Posted: July 29, 2010    Key Record Dates
Last Update Posted: July 29, 2010
Last Verified: July 2010

Keywords provided by The University of Hong Kong:
obstructive sleep apnea
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases