Obstructive Sleep Apnea and Diabetes Mellitus - Full Text View

Sponsored by:	The University of Hong Kong
Information provided by:	The University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00876980

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

MedlinePlus related topics: Diabetes Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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.

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:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator nCPAP treatment	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.
2: No Intervention controls for 3-month observation

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:

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)
BMI >=35
Pregnant or lactating women

Contacts and Locations

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

Contacts

Contact: Jamie C Lam, MRCP	852-28553111	lamcmj@hku.hk
Contact: Mary S Ip, MD	852-28554455	msmip@hku.hk

Locations

Hong Kong
Queen Mary Hospital, University Department of Medicine	Recruiting
Pokfulam, Hong Kong, 0000
Contact: Jamie C Lam, MRCP 852-28553111 lamcmj@hku.hk
Contact: Mary S Ip, MD 852-28554455 msmip@hku.hk

Sponsors and Collaborators

The University of Hong Kong

Investigators

Principal Investigator:

Mary S Ip, MD

The University of Hong Kong

More Information

Publications:

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.

Responsible Party:	The University of Hong Kong / Queen Mary Hospital ( Professor Mary SM Ip )
Study ID Numbers:	HKCTR-676
Study First Received:	March 23, 2009
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00876980 History of Changes
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

Study placed in the following topic categories:

Sleep Apnea Syndromes
Metabolic Diseases
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Diabetes Mellitus
Dyssomnias
Endocrine System Diseases
Sleep Disorders

Sleep Disorders, Intrinsic
Signs and Symptoms
Respiratory Tract Diseases
Diabetes Mellitus, Type 2
Signs and Symptoms, Respiratory
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Metabolic Diseases
Apnea
Nervous System Diseases
Sleep Apnea, Obstructive
Respiration Disorders
Diabetes Mellitus
Sleep Disorders

Dyssomnias
Endocrine System Diseases
Sleep Disorders, Intrinsic
Signs and Symptoms
Respiratory Tract Diseases
Diabetes Mellitus, Type 2
Signs and Symptoms, Respiratory
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009