Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients: The EPIMOOSA Study

Aragon Institute of Health Sciences70 enrolled

Overview

This study evaluates epigenetics in morbid obese patients who are waiting for bariatric surgery. A home cardiopulmonary polygraphy is performed to evaluate for the presence of sleep-disordered breathing. The principal investigator make the decision of starting CPAP among patients with obstructive sleep apnea according to current clinical guidelines. One year follow up after bariatric surgery will be performed. A total of 5 visits will be scheduled: two of them before bariatric surgery and 3 after (3, 6 and 12 months). At every visit, all patients had: sleep questionaries, blood samples, EKG-Holter and spirometry are collected.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obstructive Sleep Apnea Morbid Obesity Epigenetic Disorder

Interventions

CPAPDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * BMI consistently \> 40 kg/m2 for 3-5 years, following more than 1 year of unsuccessful controlled medical treatment * BMI 35-40 kg/m2 with comorbidities associated with morbid obesity (MO) susceptible to improvement with weight loss (high BP, Diabetes, dyslipidemia, OSA, etc.), following more than 1 year of unsuccessful controlled medical treatment. * A signed informed consent form Exclusion Criteria: * Obesity hypoventilation syndrome or treatment with positive pressure devices. * Diagnosis of systemic inflammatory disease. * Neoplastic diseases in the last 5 years. * A cardiovascular event in the last 6 months. * Pregnancy

Outcomes

Primary Outcomes

Epigenetics changes in morbid obesity patient with or without obstructive sleep apnea (OSA)

To evaluate differences in miRNA profile among patients with morbid obesity with or without OSA Differences between exosome miRNA of MO+OSA and MO-OSA will be calculated. The results will be expressed following the method 2(delta-delta C(T)) miRNA will be analyzed: miRNA 16, 21, 34, 126, 133, 145, 146, 155, 223, 320.

Time frame: 2 years

Secondary Outcomes

Impact of CPAP treatment in epigenetics changes.

miRNA profile will be assessed In patient with morbid obesity and coexistent OSA, at baseline and after 6 months of treatment with CPAP according with current guidelines.

Time frame: 6 months

Impact of weight loss due to bariatric surgery in epigenetics changes.

All participants included will go to bariatric surgery and 3, 6 and 12 month blood samples will be obtained. miRNA will be analyzed in the last 2 visits and compared with previous.

Time frame: 12 months