Obstructive Sleep Apnea and Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lam Jamie Chung Mei, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00876980
First received: March 23, 2009
Last updated: October 15, 2013
Last verified: October 2013

March 23, 2009
October 15, 2013
May 2008
February 2012   (final data collection date for primary outcome measure)
HbA1C [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00876980 on ClinicalTrials.gov Archive Site
Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Obstructive Sleep Apnea and Diabetes Mellitus
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obstructive Sleep Apnea
  • Diabetes Mellitus
Device: nasal Continuous Positive Airway Pressure
A standard treatment for OSA. A portable machine delivers positive pressure through a mask to the upper airway during sleep at night.
Other Name: nCPAP
  • Active Comparator: 1
    nasal Continuous Positive Airway Pressure treatment for 3 months
    Intervention: Device: nasal Continuous Positive Airway Pressure
  • No Intervention: 2
    controls have no treatment, being observed for 3 months
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. Epub 2007 Jun 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with type II DM on a stable medication regimen (on diet / oral hypoglycaemic agents / insulin injections)
  2. Age 25 - 70 years
  3. HbA1C > 7%
  4. AHI >= 15
  5. Able to give written informed consent

Exclusion Criteria:

  1. Patients with severe co-existing illness or poor functional performance
  2. Patients with peripheral vascular diseases, vasculitis / Raynaud's syndrome or thrombocytopenia
  3. Sleep disorders other than OSA
  4. Patients who refuse nCPAP treatment for OSA
  5. Excessive sleepiness causing potential harm (e.g. driver)
  6. HbA1C >=7%
  7. Habitual drinker (defined as more than 3 times a week)
  8. Pregnant or lactating women
Both
25 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00876980
HKCTR-676
Yes
Lam Jamie Chung Mei, The University of Hong Kong
The University of Hong Kong
Not Provided
Principal Investigator: Mary S Ip, MD The University of Hong Kong
The University of Hong Kong
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP