NCT01172093

Brief Summary

OSA is prevalent among patients with type II DM

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2010

Completed
Last Updated

July 29, 2010

Status Verified

July 1, 2010

Enrollment Period

1.4 years

First QC Date

July 27, 2010

Last Update Submit

July 28, 2010

Conditions

Keywords

obstructive sleep apneaprevalencediabetes mellitusChinese

Outcome Measures

Primary Outcomes (1)

  • presence of OSA

    The diagnosis of OSA will be confirmed with polysomnography

    measured at a single time point during the recruitment period(2007-08), by polysomnography

Secondary Outcomes (2)

  • severity of OSA

    measured at a single time point during the recruitment period(2007-08), by polysomnography

  • glycemic control

    measured at a single time point, when the subjects were admitted for polysomnography (during 2007-08)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, 852, Hong Kong

Location

Related Publications (7)

  • Aronsohn RS, Whitmore H, Van Cauter E, Tasali E. Impact of untreated obstructive sleep apnea on glucose control in type 2 diabetes. Am J Respir Crit Care Med. 2010 Mar 1;181(5):507-13. doi: 10.1164/rccm.200909-1423OC. Epub 2009 Dec 17.

    PMID: 20019340BACKGROUND
  • Elmasry A, Lindberg E, Berne C, Janson C, Gislason T, Awad Tageldin M, Boman G. Sleep-disordered breathing and glucose metabolism in hypertensive men: a population-based study. J Intern Med. 2001 Feb;249(2):153-61. doi: 10.1046/j.1365-2796.2001.00787.x.

    PMID: 11240844BACKGROUND
  • Resnick HE, Redline S, Shahar E, Gilpin A, Newman A, Walter R, Ewy GA, Howard BV, Punjabi NM; Sleep Heart Health Study. Diabetes and sleep disturbances: findings from the Sleep Heart Health Study. Diabetes Care. 2003 Mar;26(3):702-9. doi: 10.2337/diacare.26.3.702.

    PMID: 12610025BACKGROUND
  • West SD, Nicoll DJ, Stradling JR. Prevalence of obstructive sleep apnoea in men with type 2 diabetes. Thorax. 2006 Nov;61(11):945-50. doi: 10.1136/thx.2005.057745. Epub 2006 Aug 23.

    PMID: 16928713BACKGROUND
  • Ronksley PE, Hemmelgarn BR, Heitman SJ, Hanly PJ, Faris PD, Quan H, Tsai WH. Obstructive sleep apnoea is associated with diabetes in sleepy subjects. Thorax. 2009 Oct;64(10):834-9. doi: 10.1136/thx.2009.115105. Epub 2009 Aug 12.

    PMID: 19679579BACKGROUND
  • Foster GD, Sanders MH, Millman R, Zammit G, Borradaile KE, Newman AB, Wadden TA, Kelley D, Wing RR, Sunyer FX, Darcey V, Kuna ST; Sleep AHEAD Research Group. Obstructive sleep apnea among obese patients with type 2 diabetes. Diabetes Care. 2009 Jun;32(6):1017-9. doi: 10.2337/dc08-1776. Epub 2009 Mar 11.

    PMID: 19279303BACKGROUND
  • Lam DC, Lui MM, Lam JC, Ong LH, Lam KS, Ip MS. Prevalence and recognition of obstructive sleep apnea in Chinese patients with type 2 diabetes mellitus. Chest. 2010 Nov;138(5):1101-7. doi: 10.1378/chest.10-0596. Epub 2010 Aug 12.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and serum samples were collected from subjects for batch assays for further research purposes

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDiabetes Mellitus

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • David CL Lam, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2010

First Posted

July 29, 2010

Study Start

January 1, 2007

Primary Completion

June 1, 2008

Study Completion

December 1, 2008

Last Updated

July 29, 2010

Record last verified: 2010-07

Locations