Obstructive Sleep Apnea and Diabetes Mellitus

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00876980

Enrollment

Registered

2009-04-07

Start date

2008-05-31

Completion date

2012-02-29

Last updated

2013-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Diabetes Mellitus

Keywords

Obstructive sleep apnea, Type II diabetes mellitus, Randomized controlled trial

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.

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.

Interventions

DEVICEnasal 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HbA1C	3 months

Secondary

Measure	Time frame
Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function	3 months

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026