Effects of CPAP on Visceral Fat Thickness

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: CPAP

• Registration Number: NCT01828281
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

We hypothesize that patients with untreated OSAS will have more visceral fat, fatty liver and increased carotid artery thickness whereas treatment with CPAP may reduce the mesenteric and liver fat, plasma lipids, carotid artery thickness.

Detailed Description

This proposed randomized control trial (RCT) will compare the effects of therapeutic CPAP versus subtherapeutic CPAP in patients newly diagnosed with OSA with reference to visceral fat especially mesenteric fat thickness, liver fat, carotid artery intima media thickness (IMT), lateral pharyngeal wall (LPW) thickness, plasma lipids and adipokines over a treatment period of 3 months. The results of this study will advance our understanding of the relative role of OSA and obesity in the pathogenesis of metabolic syndrome (MetS) and whether CPAP therapy can improve these metabolic dysregulation.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-10
• Primary Completion: 2013-10
• Study Completion: 2015-08
• Results First Submitted: 2015-08-13
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-15
• Last Update Submitted: 2015-10-15
• Results First Posted: 2015-11-16
• Last Update Posted: 2015-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

• symptomatic patients with OSA of apnea hypopnea index (AHI) >= 5/hr

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Exclusion Criteria

• Recent or past history of myocardial infarction/stroke/heart failure, unstable angina, underlying malignancy,
• patients with clinical features of any active infection
• those who require urgent CPAP treatment because of associated respiratory failure or to prevent job loss through excessive daytime sleepiness (eg professional drivers, those handling dangerous machinery)
• moderate to severe valvular heart disease, cardiomyopathy, and previous diagnosis of OSA and/or previous use of CPAP therapy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic CPAP	CPAP	Therapeutic CPAP
control	CPAP	subtherapeutic CPAP using 4 cm water

Primary Outcome Measures

Name	Time	Method
Mesenteric Fat Thickness	3 months

Secondary Outcome Measures

Name	Time	Method
Mean Changes in Adiponectin Over 3 Months	Baseline, 3 months	Mean changes in Adiponectin from baseline to 3 months.

Trial Locations

Locations (1)

Respiratory Division; 🇨🇳 Hong Kong, China