Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— TREATOSA-MS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295202
• Other study ID #: SDC 4075/14/055
• Status: Completed
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: December 2019

Study information

• Verified date: June 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Metabolic Syndrome
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• CPAP (REMstar System One Plus - Philips Medical Systems)
Standard device for treating obstructive sleep apnea.
• Nasal strips

Locations

Country	Name	City	State
Brazil	Luciano Drager	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fleury

Country where clinical trial is conducted

Brazil, 

Outcome

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