Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome (TREATOSA-MS)
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ClinicalTrials.gov Identifier: NCT02295202 |
Recruitment Status :
Completed
First Posted : November 20, 2014
Last Update Posted : June 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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Sleep Apnea Metabolic Syndrome | Device: CPAP (REMstar System One Plus - Philips Medical Systems) Device: Nasal strips | Phase 4 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: CPAP
CPAP: Continuous Positive Airway Pressure - Device used for treating OSA during sleep.
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Device: CPAP (REMstar System One Plus - Philips Medical Systems)
Standard device for treating obstructive sleep apnea. |
Placebo Comparator: Placebo
Nasal Strips
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Device: Nasal strips |
- Reversibility of Metabolic Syndrome criteria [ Time Frame: 6 months ]
- Abdominal fat [ Time Frame: 6 months ]Abdominal CT
- Hepatic steatosis [ Time Frame: 6 months ]Abdominal CT
- carotid intima-media thickness [ Time Frame: 6 months ]Carotid ultrasound
- endothelial function [ Time Frame: 6 months ]Braquial artery ultrasound (flow mediated dilation, %)
- coronary atherosclerosis [ Time Frame: 6 months ]Coronary CT
- Inflammatory markers [ Time Frame: 6 months ]C-reactive protein
- Metabolomics [ Time Frame: 6 months ]Metabolomic analysis (intended to be a sub-study)
- MicroRNAs [ Time Frame: 6 months ]MicroRNAs analysis (intended to be a sub-study)
- Epicardic fat [ Time Frame: 6 months ]Epicardic fat quantification by CT (intended to be a sub-study)
- Heart remodeling [ Time Frame: 6 months ]Evaluated by Tranthoracic echocardiography (intended to be a sub-study)

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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 |
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.

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