Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02295202

Acronym

TREATOSA-MS

Enrollment

100

Registered

2014-11-20

Start date

2015-03-31

Completion date

2019-12-31

Last updated

2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Sleep Apnea

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.

Interventions

DEVICECPAP (REMstar System One Plus - Philips Medical Systems)

Standard device for treating obstructive sleep apnea.

DEVICENasal strips

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Reversibility of Metabolic Syndrome criteria	6 months

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026