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

Completed

• Conditions: Epigenetic Disorder; Morbid Obesity; Obstructive Sleep Apnea
• Interventions: Device: CPAP; Procedure: Bariatric Surgery

• Registration Number: NCT03995836
• Lead Sponsor: Aragon Institute of Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-01
• Primary Completion: 2016-07-01
• Study Completion: 2018-07-01
• Study First Submitted: 2019-05-13
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-20
• Last Update Submitted: 2019-06-20
• Study First Posted: 2019-06-24
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obstructive Sleep Apnea	CPAP	-
Obstructive Sleep Apnea	Bariatric Surgery	-
Non Obstructive Sleep Apnea	Bariatric Surgery	-

Primary Outcome Measures

Name	Time	Method
Epigenetics changes in morbid obesity patient with or without obstructive sleep apnea (OSA)	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Impact of CPAP treatment in epigenetics changes.	6 months	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.
Impact of weight loss due to bariatric surgery in epigenetics changes.	12 months	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.