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Obstructive Sleep Apnea and Diabetes Mellitus

NCT ID: NCT00876980

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea Diabetes Mellitus

Keywords

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Obstructive sleep apnea Type II diabetes mellitus Randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

nasal Continuous Positive Airway Pressure treatment for 3 months

Group Type ACTIVE_COMPARATOR

nasal Continuous Positive Airway Pressure

Intervention Type DEVICE

A standard treatment for OSA. A portable machine delivers positive pressure through a mask to the upper airway during sleep at night.

2

controls have no treatment, being observed for 3 months

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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nCPAP

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Lam Jamie Chung Mei

Honorary clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary S Ip, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Queen Mary Hospital, University Department of Medicine

Pokfulam, Hong Kong, Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type RESULT
PMID: 17557769 (View on PubMed)

Other Identifiers

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HKCTR-676

Identifier Type: -

Identifier Source: org_study_id