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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02295202
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : June 18, 2020
Sponsor:
Collaborator:
Fleury
Information provided by (Responsible Party):
Luciano F Drager, MD, PhD, University of Sao Paulo

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Metabolic Syndrome Device: CPAP (REMstar System One Plus - Philips Medical Systems) Device: Nasal strips Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome: A Randomized Study
Study Start Date : March 2015
Actual Primary Completion Date : April 2019
Actual Study Completion Date : December 2019

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Reversibility of Metabolic Syndrome criteria [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Abdominal fat [ Time Frame: 6 months ]
    Abdominal CT

  2. Hepatic steatosis [ Time Frame: 6 months ]
    Abdominal CT

  3. carotid intima-media thickness [ Time Frame: 6 months ]
    Carotid ultrasound

  4. endothelial function [ Time Frame: 6 months ]
    Braquial artery ultrasound (flow mediated dilation, %)

  5. coronary atherosclerosis [ Time Frame: 6 months ]
    Coronary CT

  6. Inflammatory markers [ Time Frame: 6 months ]
    C-reactive protein

  7. Metabolomics [ Time Frame: 6 months ]
    Metabolomic analysis (intended to be a sub-study)

  8. MicroRNAs [ Time Frame: 6 months ]
    MicroRNAs analysis (intended to be a sub-study)

  9. Epicardic fat [ Time Frame: 6 months ]
    Epicardic fat quantification by CT (intended to be a sub-study)

  10. Heart remodeling [ Time Frame: 6 months ]
    Evaluated by Tranthoracic echocardiography (intended to be a sub-study)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295202


Locations
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Brazil
Luciano Drager
Sao Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Fleury
Investigators
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Principal Investigator: Luciano F Drager, MD, PhD Heart Institute (InCor), University of Sao Paulo Medical School
More Information
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Responsible Party: Luciano F Drager, MD, PhD, Luciano F. Drager, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02295202    
Other Study ID Numbers: SDC 4075/14/055
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases