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Clinical Trials/NCT02295202
NCT02295202
Completed
Phase 4

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

University of Sao Paulo1 site in 1 country100 target enrollmentMarch 2015
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ConditionsSleep ApneaMetabolic Syndrome

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Sleep Apnea
Sponsor
University of Sao Paulo
Enrollment
100
Locations
1
Primary Endpoint
Reversibility of Metabolic Syndrome criteria
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
December 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Luciano F Drager, MD, PhD

Luciano F. Drager

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Reversibility of Metabolic Syndrome criteria

Time Frame: 6 months

Secondary Outcomes

  • Hepatic steatosis(6 months)
  • coronary atherosclerosis(6 months)
  • Abdominal fat(6 months)
  • Inflammatory markers(6 months)
  • MicroRNAs(6 months)
  • endothelial function(6 months)
  • Metabolomics(6 months)
  • Heart remodeling(6 months)
  • carotid intima-media thickness(6 months)
  • Epicardic fat(6 months)

Study Sites (1)

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