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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients (EPIMOOSA): Continous Positive Airway Pressure (CPAP) and Bariatric Surgery Impact. EPIMOOSA Study

Conditions
-----------------
Obstructive Sleep Apnea, Morbid Obesity, Epigenetic Disorder

Intervention / Treatment
-----------------
* Device: CPAP
* Procedure: Bariatric Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obstructive Sleep Apnea<br> | Device: CPAP<br>* Decision of CPAP treatment is according to clinical guidelines<br>Procedure: Bariatric Surgery<br>* All patients.<br>|
| Non Obstructive Sleep Apnea<br> | Procedure: Bariatric Surgery<br>* All patients.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Sleep Apnea, Morbid Obesity, Epigenetics, Bariatric Surgery