Text Size

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

This study has been completed.
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01172093
First received: July 27, 2010
Last updated: July 28, 2010
Last verified: July 2010
History of Changes
  Purpose

OSA is prevalent among patients with type II DM


Condition
Obstructive Sleep Apnea
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalence and Recognition of Obstructive Sleep Apnea in Chinese With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • presence of OSA [ Time Frame: measured at a single time point during the recruitment period(2007-08), by polysomnography ] [ Designated as safety issue: No ]
    The diagnosis of OSA will be confirmed with polysomnography


Secondary Outcome Measures:
  • severity of OSA [ Time Frame: measured at a single time point during the recruitment period(2007-08), by polysomnography ] [ Designated as safety issue: No ]
    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 [ Time Frame: measured at a single time point, when the subjects were admitted for polysomnography (during 2007-08) ] [ Designated as safety issue: No ]
    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


Enrollment: 177
Study Start Date: January 2007
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172093

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Professor Ip Sau Man Mary, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01172093     History of Changes
Other Study ID Numbers: UW07-060
Study First Received: July 27, 2010
Last Updated: July 28, 2010
Health Authority: Hong Kong: Ethics Committee

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

Additional relevant MeSH terms:
Apnea
Diabetes Mellitus
Diabetes Mellitus, Type 2
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013