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Obstructive Sleep Apnea and Diabetes Mellitus

This study is ongoing, but not recruiting participants.
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: November 15, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention
Obstructive Sleep Apnea
Diabetes Mellitus
 Device: nasal Continuous Positive Airway Pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • HbA1C [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: May 2008
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876980

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

Publications:

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
Study First Received: March 23, 2009
Last Updated: November 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Hong Kong:
Obstructive sleep apnea
Type II diabetes mellitus
Randomized controlled trial

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

ClinicalTrials.gov processed this record on May 23, 2013