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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Body Weight Dyssomnias Epigenetic Disorder Morbid Obesity Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

Decision of CPAP treatment is according to clinical guidelines

bariatric surgery

Procedure

All patients.

Primary outcomes

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

Time frame: 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 outcomes

Impact of CPAP treatment in epigenetics changes.

Time frame: 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.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aragon Institute of Health Sciences

Other

Registry information

Official study title

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

Acronym: EPIMOOSA

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2018
First posted: Jun 24, 2019
Registry last updated: Jun 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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