Obstructive Sleep Apnea and Diabetes Mellitus

Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876980
• Other study ID #: HKCTR-676
• Status: Completed
• Phase: N/A
• First received: March 23, 2009
• Last updated: October 15, 2013
• Start date: May 2008
• Est. completion date: February 2012

Study information

• Verified date: October 2013
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• nasal 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.

Locations

Country	Name	City	State
Hong Kong	Queen Mary Hospital, University Department of Medicine	Pokfulam

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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. Epub 2007 Jun 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1C		3 months	No
Secondary	Fasting glucose & fructosamine microalbuminuria blood pressure lipids endothelial function		3 months	No