Obstructive Sleep Apnea and Diabetes Mellitus

October 15, 2013 updated by: Lam Jamie Chung Mei, The University of Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Pokfulam, Hong Kong, 0000
        • Queen Mary Hospital, University Department of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • nCPAP
No Intervention: 2
controls have no treatment, being observed for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1C
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Mary S Ip, MD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

March 23, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (Estimate)

April 7, 2009

Study Record Updates

Last Update Posted (Estimate)

October 16, 2013

Last Update Submitted That Met QC Criteria

October 15, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKCTR-676

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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