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Completed

NCT Number: NCT00876980

Obstructive Sleep Apnea and 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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Diabetes Mellitus Diabetes Mellitus, Type 2 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital, University Department of Medicine

Pokfulam, Hong Kong, 0000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • Pregnant or lactating women

Treatment and study plan

nasal Continuous Positive Airway Pressure

Device

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

Primary outcomes

  1. HbA1C

    Time frame: 3 months

Secondary outcomes

  1. Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 7, 2009
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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