Clinical trial NCT00876980: Obstructive Sleep Apnea and Diabetes Mellitus
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Diabetes Mellitus
Keywords: Obstructive sleep apnea
Type II diabetes mellitus
Randomized controlled trial
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 64
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1C
timeFrame: 3 months
Secondary outcomes:
measure: Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function
timeFrame: 3 months
Other outcomes:
Locations:
city: Pokfulam
country: Hong Kong
facility: Queen Mary Hospital, University Department of Medicine
Study officials:
affiliation: The University of Hong Kong
name: Mary S Ip, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1136/thx.2006.074351. Epub 2007 Jun 8.