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OpenTrials
Completed

NCT Number: NCT02295202

Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome

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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Luciano Drager

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPAP (REMstar System One Plus - Philips Medical Systems)

Device

Standard device for treating obstructive sleep apnea.

Nasal strips

Device

Primary outcomes

  1. Reversibility of Metabolic Syndrome criteria

    Time frame: 6 months

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fleury

Registry information

Official study title

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

Acronym: TREATOSA-MS

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2014
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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