Obstructive Sleep ApneaNCT01172093
A Study on the Prevalence of Obstructive Sleep Apnea in Patients With Type II Diabetes Mellitus
An observational study of Obstructive Sleep Apnea and Diabetes Mellitus, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
OSA is prevalent among patients with type II DM Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea, Diabetes Mellitus
- How many people
- 177 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2007to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Chinese subjects with type 2 diabetes mellitus being followed up at the diabetic clinic of a University affiliated hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Recognition of Obstructive Sleep Apnea in Chinese With Type 2 Diabetes Mellitus
OSA is prevalent among patients with type II DM
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Diabetes Mellitus
- Keywords
- obstructive sleep apnea, prevalence, diabetes mellitus, Chinese
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of OSA
The diagnosis of OSA will be confirmed with polysomnography
Measured: measured at a single time point during the recruitment period(2007-08), by polysomnography
Secondary outcomes (2)
severity of OSA
The severity of OSA will be assessed in terms of apnea hypopnea index, minimal oxygen saturation, duration of desaturation, arousal index during polysomnography
Measured: measured at a single time point during the recruitment period(2007-08), by polysomnography
glycemic control
by measuring glycosylated hemoglobin, blood glucose level
Measured: measured at a single time point, when the subjects were admitted for polysomnography (during 2007-08)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2010 (estimated)
- Study startJan 2007
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- David CL Lam, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172093
- Sponsor's protocol ID
- UW07-060
- Status last verified
- Jul 2010
- First submitted
- 27 Jul 2010
- Last updated
- 29 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20019340Elmasry 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.
PubMed 11240844Resnick 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.
PubMed 12610025West 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.
PubMed 16928713Ronksley 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.
PubMed 19679579Foster 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.
PubMed 19279303Lam 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.
PubMed 20705796
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Recognition of Obstructive Sleep Apnea in Chinese With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01172093
- Acronym / sponsor ID
- UW07-060
- Conditions
- Obstructive Sleep Apnea, Diabetes Mellitus
- Keywords
- obstructive sleep apnea, prevalence, diabetes mellitus, Chinese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 29 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OSA is prevalent among patients with type II DM
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Chinese subjects with type 2 diabetes mellitus being followed up at the diabetic clinic of a University affiliated hospital
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
severity of OSA
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2010.
- Background: PubMed 20019340Aronsohn 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.
- Background: PubMed 11240844Elmasry 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.
- Background: PubMed 12610025Resnick 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.
- Background: PubMed 16928713West 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.
- Background: PubMed 19679579Ronksley 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.
- Background: PubMed 19279303Foster 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.
- Derived from this study: PubMed 20705796Lam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David CL Lam, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Diabetes Mellitus, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of OSA (time frame: measured at a single time point during the recruitment period(2007-08), by polysomnography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01172093, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2010; AzTrials last refreshed its copy on 6 Nov 2026.