Obstructive Sleep Apnea and Diabetes Mellitus
Primary Purpose
Obstructive Sleep Apnea, Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
nasal Continuous Positive Airway Pressure
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Type II diabetes mellitus, Randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Queen Mary Hospital, University Department of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1
2
Arm Description
nasal Continuous Positive Airway Pressure treatment for 3 months
controls have no treatment, being observed for 3 months
Outcomes
Primary Outcome Measures
HbA1C
Secondary Outcome Measures
Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function
Full Information
NCT ID
NCT00876980
First Posted
March 23, 2009
Last Updated
October 15, 2013
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00876980
Brief Title
Obstructive Sleep Apnea and Diabetes Mellitus
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Diabetes Mellitus
Keywords
Obstructive sleep apnea, Type II diabetes mellitus, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
nasal Continuous Positive Airway Pressure treatment for 3 months
Arm Title
2
Arm Type
No Intervention
Arm Description
controls have no treatment, being observed for 3 months
Intervention Type
Device
Intervention Name(s)
nasal Continuous Positive Airway Pressure
Other Intervention Name(s)
nCPAP
Intervention Description
A standard treatment for OSA. A portable machine delivers positive pressure through a mask to the upper airway during sleep at night.
Primary Outcome Measure Information:
Title
HbA1C
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary S Ip, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital, University Department of Medicine
City
Pokfulam
ZIP/Postal Code
0000
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
17557769
Citation
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.
Results Reference
result
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Obstructive Sleep Apnea and Diabetes Mellitus
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