Effects of CPAP on Visceral Fat Thickness

October 15, 2015 updated by: Prof David Shu Cheong Hui, Chinese University of Hong Kong

A Randomized Controlled Study on the Effects of Continuous Positive Airway Pressure (CPAP) on Visceral Fat Thickness, Carotid Intima-media Thickness and Adipokines in Patients With Obstructive Sleep Apnoea Syndrome (OSAS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

141

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Respiratory Division

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Therapeutic CPAP
Device: CPAP
All subjects will undergo ultrasound examination of the abdomen the day after overnight polysomnography (PSG) and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water.
Sham Comparator: control
subtherapeutic CPAP using 4 cm water
Device: CPAP
All subjects will undergo ultrasound examination of the abdomen the day after overnight polysomnography (PSG) and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mesenteric Fat Thickness
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Changes in Adiponectin Over 3 Months
Time Frame: Baseline, 3 months
Mean changes in Adiponectin from baseline to 3 months.
Baseline, 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Hours of CPAP Usage Per Day
Time Frame: 3 months
Mean Hours of CPAP usage per day in those who continue to use CPAP during the three month period.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Hui David, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 8, 2013

First Posted (Estimate)

April 10, 2013

Study Record Updates

Last Update Posted (Estimate)

November 16, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VF-CPAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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