Obstructive Sleep ApneaNCT00876980
Obstructive Sleep Apnea and Diabetes Mellitus
A study testing nasal Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea and Diabetes Mellitus, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The investigators hypothesize that obstructive sleep apnea (OSA) contributes to impaired glucose homeostasis and associated vasculopathy, and nCPAP treatment of OSA should improve glycemic control and vascular function in OSA patients with type II diabetes mellitus. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea, Diabetes Mellitus
- What is being tested?
- nasal Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2008to Feb 2012
- Phase
- Interventional
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type II DM on a stable medication regimen (on diet / oral hypoglycaemic agents / insulin injections)
- Age 25 - 70 years
- HbA1C > 7%
- AHI >= 15
- Able to give written informed consent
Who cannot join
- Patients with severe co-existing illness or poor functional performance
- Patients with peripheral vascular diseases, vasculitis / Raynaud's syndrome or thrombocytopenia
- Sleep disorders other than OSA
- Patients who refuse nCPAP treatment for OSA
- Excessive sleepiness causing potential harm (e.g. driver)
- HbA1C >=7%
- Habitual drinker (defined as more than 3 times a week)
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Queen Mary Hospital, University Department of Medicine
Pokfulam, Hong Kong, 0000
About this study
Official title: The Effect of Nasal Continuous Positive Airway Pressure Treatment on Glycemic Control and Vascular Function in Patients With Obstructive Sleep Apnea and Type II Diabetes Mellitus.
The investigators hypothesize that obstructive sleep apnea (OSA) contributes to impaired glucose homeostasis and associated vasculopathy, and nCPAP treatment of OSA should improve glycemic control and vascular function in OSA patients with type II diabetes mellitus. This study aims to investigate the therapeutic effects of nCPAP on glycemic control and vascular function in patients with OSA and type II diabetes mellitus.
Read the detailed description
Obstructive sleep apnoea (OSA) has been reported to be common (17%) in patients with diabetes mellitus (DM). Both OSA and DM are highly associated with cardiovascular morbidity and mortality. There is growing evidence that OSA may trigger or worsen pre-existing adverse metabolic profile indicative of cardiovascular risk. Treatment of OSA with nasal Continuous Positive Airway Pressure (nCPAP) has been shown to reduce blood pressure and hence to reduce the risk of atherogenesis. In patients with DM, the therapeutic effect of nCPAP is still not known, it would be important to delineate any independent effect of OSA on DM and the therapeutic effect of nCPAP on glycemic control to reduce the long term risk of macrovascular and microvascular complications.
- Conditions
- Obstructive Sleep Apnea, Diabetes Mellitus
- Being tested
- nasal Continuous Positive Airway Pressure
- Keywords
- Obstructive sleep apnea, Type II diabetes mellitus, Randomized controlled trial
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal Continuous Positive Airway PressureDevice
Also called nCPAP
A standard treatment for OSA. A portable machine delivers positive pressure through a mask to the upper airway during sleep at night.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | nasal Continuous Positive Airway Pressure treatment for 3 months Receives: Device: nasal Continuous Positive Airway Pressure |
| 2 | No intervention | controls have no treatment, being observed for 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
Measured: 3 months
Secondary outcomes (1)
Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startMay 2008
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lam Jamie Chung Mei, The University of Hong Kong
- Investigators
- Mary S Ip, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876980
- Sponsor's protocol ID
- HKCTR-676
- Status last verified
- Oct 2013
- First submitted
- 23 Mar 2009
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
West SD, Nicoll DJ, Wallace TM, Matthews DR, Stradling JR. Effect of CPAP on insulin resistance and HbA1c in men with obstructive sleep apnoea and type 2 diabetes. Thorax. 2007 Nov;62(11):969-74. doi: 10.1136/thx.2006.074351. Epub 2007 Jun 8.
PubMed 17557769
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nasal Continuous Positive Airway Pressure Treatment on Glycemic Control and Vascular Function in Patients With Obstructive Sleep Apnea and Type II Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT00876980
- Acronym / sponsor ID
- HKCTR-676
- Conditions
- Obstructive Sleep Apnea, Diabetes Mellitus
- Keywords
- Obstructive sleep apnea, Type II diabetes mellitus, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Apr 2009 (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.
The investigators hypothesize that obstructive sleep apnea (OSA) contributes to impaired glucose homeostasis and associated vasculopathy, and nCPAP treatment of OSA should improve glycemic control and vascular function in OSA patients with type II diabetes mellitus. This study aims to investigate the therapeutic effects of nCPAP on glycemic control and vascular function in patients with OSA and type II diabetes mellitus.
Detailed description
Obstructive sleep apnoea (OSA) has been reported to be common (17%) in patients with diabetes mellitus (DM). Both OSA and DM are highly associated with cardiovascular morbidity and mortality. There is growing evidence that OSA may trigger or worsen pre-existing adverse metabolic profile indicative of cardiovascular risk. Treatment of OSA with nasal Continuous Positive Airway Pressure (nCPAP) has been shown to reduce blood pressure and hence to reduce the risk of atherogenesis. In patients with DM, the therapeutic effect of nCPAP is still not known, it would be important to delineate any independent effect of OSA on DM and the therapeutic effect of nCPAP on glycemic control to reduce the long term risk of macrovascular and microvascular complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: nasal Continuous Positive Airway Pressurenasal Continuous Positive Airway Pressure treatment for 3 months |
| 2 | No intervention | –controls have no treatment, being observed for 3 months |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with type II DM on a stable medication regimen (on diet / oral hypoglycaemic agents / insulin injections)
- Age 25 - 70 years
- HbA1C > 7%
- AHI >= 15
- Able to give written informed consent
Key exclusion criteria (8 listed)
- Patients with severe co-existing illness or poor functional performance
- Patients with peripheral vascular diseases, vasculitis / Raynaud's syndrome or thrombocytopenia
- Sleep disorders other than OSA
- Patients who refuse nCPAP treatment for OSA
- Excessive sleepiness causing potential harm (e.g. driver)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal Continuous Positive Airway PressureAlso: nCPAPA standard treatment for OSA. A portable machine delivers positive pressure through a mask to the upper airway during sleep at night. | Device | 1 |
Primary outcome
HbA1C
Time frame: 3 months
1 secondary outcome
Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function
Time frame: 3 months
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 16 Oct 2013.
- Results publication: PubMed 17557769West SD, Nicoll DJ, Wallace TM, Matthews DR, Stradling JR. Effect of CPAP on insulin resistance and HbA1c in men with obstructive sleep apnoea and type 2 diabetes. Thorax. 2007 Nov;62(11):969-74. doi: 10.1136/thx.2006.074351. Epub 2007 Jun 8.
Related trials for Obstructive Sleep Apnea
Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
Not yet recruitingObservational study
Association Between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea
Obstructive Sleep Apnea, Metabolic Dysfunction-Associated Steatotic Liver Disease
Not yet recruitingPhase 2/3
Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea
Sleep Apnoea, Obesity & Overweight
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
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.
Mary S Ip, MD 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?
A study testing nasal Continuous Positive Airway Pressure in people with 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 5 inclusion and 8 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 16 Oct 2013. 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?
HbA1C (time frame: 3 months). 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 NCT00876980, which also lists 1 linked publication.
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 16 Oct 2013.