Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome

Phase 4

Completed

• Conditions: Sleep Apnea; Metabolic Syndrome
• Interventions: Device: CPAP (REMstar System One Plus - Philips Medical Systems); Device: Nasal strips

• Registration Number: NCT02295202
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-20
• Study Start: 2015-03
• Primary Completion: 2019-04
• Study Completion: 2019-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-17
• Last Update Posted: 2020-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP	CPAP (REMstar System One Plus - Philips Medical Systems)	CPAP: Continuous Positive Airway Pressure - Device used for treating OSA during sleep.
Placebo	Nasal strips	Nasal Strips

Primary Outcome Measures

Name	Time	Method
Reversibility of Metabolic Syndrome criteria	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Luciano Drager; 🇧🇷 Sao Paulo, Brazil