Obstructive Sleep Apnea and Diabetes Mellitus

The University of Hong Kong (HKU)

Status: Completed

Conditions: Diabetes Mellitus; Obstructive Sleep Apnea

Treatments: Device: nasal Continuous Positive Airway Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT00876980

HKCTR-676

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

64 participants in 2 patient groups

1

Active Comparator group

Description:

nasal Continuous Positive Airway Pressure treatment for 3 months

Treatment:

Device: nasal Continuous Positive Airway Pressure

2

No Intervention group

Description:

controls have no treatment, being observed for 3 months