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Obstructive Sleep Apnea and Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00876980
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Diabetes Mellitus Device: nasal Continuous Positive Airway Pressure

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2008
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
nasal Continuous Positive Airway Pressure treatment for 3 months
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
No Intervention: 2
controls have no treatment, being observed for 3 months

Outcome Measures

Primary Outcome Measures :
  1. HbA1C [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876980

Hong Kong
Queen Mary Hospital, University Department of Medicine
Pokfulam, Hong Kong, 0000
Sponsors and Collaborators
The University of Hong Kong
Principal Investigator: Mary S Ip, MD The University of Hong Kong
More Information

Responsible Party: Lam Jamie Chung Mei, Honorary clinical assistant professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00876980     History of Changes
Other Study ID Numbers: HKCTR-676
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by Lam Jamie Chung Mei, The University of Hong Kong:
Obstructive sleep apnea
Type II diabetes mellitus
Randomized controlled trial

Additional relevant MeSH terms:
Diabetes Mellitus
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases