MedTrace Logo

NPPV on Inflammatory Markers and Sleep in Severe Obese Patients With Metabolic Syndrome Undergone to Bariatric Surgery

NCT02409173 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2018-06-15

No results posted yet for this study

Summary

Obesity is currently one of the most serious public health problems. Its prevalence is increasing sharply in recent decades, even in developing countries, leading to global epidemiology condition. Metabolic syndrome (MS) consists of an association of metabolic and cardiovascular disorders including central obesity, insulin resistance, dyslipidemia and hypertension in the same patient. Obstructive sleep apnea (OSA) is a common clinical condition in more than 60% patients with MS. It is still controversial in the world scientific literature whether treatment of OSA with Noninvasive Positive Pressure Ventilation (NPPV) in severely obese patients with and without MS is effective. The NPPV effectively reverses hypoxemia in patients with OSA, therefore justified the hypothesis that NPPV will reduce insulin resistance, ghrelin and resistin and raise adiponectin levels in a group of severely obese individuals with and without MS undergoing bariatric surgery. Objectives: To investigate the effects of Noninvasive Positive Pressure Ventilation on inflammatory markers, sleep, pulmonary function, BMI reduction and health related quality of life in severe obese patients with and without metabolic syndrome undergone to bariatric surgery.

Conditions

  • Metabolic Syndrome

Interventions

DEVICE

Noninvasive positive airway pressure flow generator device

Noninvasive positive airway pressure flow generator device.

PROCEDURE

Bariatric Surgery

Standard Roux-en-Y gastric bypass

Sponsors & Collaborators

  • Centro Universitário de Anapolis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-05-31
Completion
2020-07-31

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02409173 on ClinicalTrials.gov