Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome (TREATOSA-MS)

June 17, 2020 updated by: Luciano F Drager, MD, PhD, University of Sao Paulo

Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome: A Randomized Study

Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to increase the morbidity associated with metabolic syndrome. This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

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

  • Brazil
      • Sao Paulo, Brazil
        • Luciano Drager

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Metabolic Syndrome (ATP III)
  • Moderate to severe OSA

Exclusion Criteria:

  • Smokers
  • Patients under chronic use of medications
  • Neurological diseases
  • Coronary artery disease
  • Acute heart failure
  • Chronic renal failure (GFR < 30 ml/min)
  • Chronic obstructive pulmonary disease
  • Mild OSA and patients with BMI over 40 kg/m2.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP
CPAP: Continuous Positive Airway Pressure - Device used for treating OSA during sleep.
Device: CPAP (REMstar System One Plus - Philips Medical Systems)
Standard device for treating obstructive sleep apnea.
Placebo Comparator: Placebo
Nasal Strips
Device: Nasal strips

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reversibility of Metabolic Syndrome criteria
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal fat
Time Frame: 6 months
Abdominal CT
6 months
Hepatic steatosis
Time Frame: 6 months
Abdominal CT
6 months
carotid intima-media thickness
Time Frame: 6 months
Carotid ultrasound
6 months
endothelial function
Time Frame: 6 months
Braquial artery ultrasound (flow mediated dilation, %)
6 months
coronary atherosclerosis
Time Frame: 6 months
Coronary CT
6 months
Inflammatory markers
Time Frame: 6 months
C-reactive protein
6 months
Metabolomics
Time Frame: 6 months
Metabolomic analysis (intended to be a sub-study)
6 months
MicroRNAs
Time Frame: 6 months
MicroRNAs analysis (intended to be a sub-study)
6 months
Epicardic fat
Time Frame: 6 months
Epicardic fat quantification by CT (intended to be a sub-study)
6 months
Heart remodeling
Time Frame: 6 months
Evaluated by Tranthoracic echocardiography (intended to be a sub-study)
6 months

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Collaborators

Fleury

Investigators

  • Principal Investigator: Luciano F Drager, MD, PhD, Heart Institute (InCor), University of Sao Paulo Medical School

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

March 1, 2015

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDC 4075/14/055

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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