Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome (TREATOSA-MS)
Primary Purpose
Sleep Apnea, Metabolic Syndrome
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
CPAP (REMstar System One Plus - Philips Medical Systems)
Nasal strips
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea
Eligibility 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.
Sites / Locations
- Luciano Drager
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CPAP
Placebo
Arm Description
CPAP: Continuous Positive Airway Pressure - Device used for treating OSA during sleep.
Nasal Strips
Outcomes
Primary Outcome Measures
Reversibility of Metabolic Syndrome criteria
Secondary Outcome Measures
Abdominal fat
Abdominal CT
Hepatic steatosis
Abdominal CT
carotid intima-media thickness
Carotid ultrasound
endothelial function
Braquial artery ultrasound (flow mediated dilation, %)
coronary atherosclerosis
Coronary CT
Inflammatory markers
C-reactive protein
Metabolomics
Metabolomic analysis (intended to be a sub-study)
MicroRNAs
MicroRNAs analysis (intended to be a sub-study)
Epicardic fat
Epicardic fat quantification by CT (intended to be a sub-study)
Heart remodeling
Evaluated by Tranthoracic echocardiography (intended to be a sub-study)
Full Information
NCT ID
NCT02295202
First Posted
November 12, 2014
Last Updated
June 17, 2020
Sponsor
University of Sao Paulo
Collaborators
Fleury
1. Study Identification
Unique Protocol Identification Number
NCT02295202
Brief Title
Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome
Acronym
TREATOSA-MS
Official Title
Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome: A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fleury
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP
Arm Type
Experimental
Arm Description
CPAP: Continuous Positive Airway Pressure - Device used for treating OSA during sleep.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Nasal Strips
Intervention Type
Device
Intervention Name(s)
CPAP (REMstar System One Plus - Philips Medical Systems)
Intervention Description
Standard device for treating obstructive sleep apnea.
Intervention Type
Device
Intervention Name(s)
Nasal strips
Primary Outcome Measure Information:
Title
Reversibility of Metabolic Syndrome criteria
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Abdominal fat
Description
Abdominal CT
Time Frame
6 months
Title
Hepatic steatosis
Description
Abdominal CT
Time Frame
6 months
Title
carotid intima-media thickness
Description
Carotid ultrasound
Time Frame
6 months
Title
endothelial function
Description
Braquial artery ultrasound (flow mediated dilation, %)
Time Frame
6 months
Title
coronary atherosclerosis
Description
Coronary CT
Time Frame
6 months
Title
Inflammatory markers
Description
C-reactive protein
Time Frame
6 months
Title
Metabolomics
Description
Metabolomic analysis (intended to be a sub-study)
Time Frame
6 months
Title
MicroRNAs
Description
MicroRNAs analysis (intended to be a sub-study)
Time Frame
6 months
Title
Epicardic fat
Description
Epicardic fat quantification by CT (intended to be a sub-study)
Time Frame
6 months
Title
Heart remodeling
Description
Evaluated by Tranthoracic echocardiography (intended to be a sub-study)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciano F Drager, MD, PhD
Organizational Affiliation
Heart Institute (InCor), University of Sao Paulo Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luciano Drager
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
35063452
Citation
Giampa SQC, Furlan SF, Freitas LS, Macedo TA, Lebkuchen A, Cardozo KHM, Carvalho VM, Martins FC, Azam IFB, Costa-Hong V, Lopes HF, Baptista ML, Rochitte CE, Bortolotto LA, Lorenzi-Filho G, Drager LF. Effects of CPAP on Metabolic Syndrome in Patients With OSA: A Randomized Trial. Chest. 2022 May;161(5):1370-1381. doi: 10.1016/j.chest.2021.12.669. Epub 2022 Jan 19.
Results Reference
derived
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Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome
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