Obstructive Sleep Apnea and Diabetes Mellitus

Study Overview
=================
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.

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.

Conditions
-----------------
Obstructive Sleep Apnea, Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: nasal Continuous Positive Airway Pressure


Participation Criteria
=================
Eligibility 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) Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>nasal Continuous Positive Airway Pressure treatment for 3 months | Device: nasal Continuous Positive Airway Pressure<br>* A standard treatment for OSA. A portable machine delivers positive pressure through a mask to the upper airway during sleep at night.<br>* Other names: nCPAP;|
| No Intervention: 2<br>controls have no treatment, being observed for 3 months | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C |  | 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive sleep apnea, Type II diabetes mellitus, Randomized controlled trial