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

Obstructive Sleep Apnea Clinical Trial

— EPIMOOSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995836
• Other study ID #: 23/2014
• Status: Completed
• Start date: July 1, 2014
• Est. completion date: July 1, 2018

Study information

• Verified date: June 2019
• Source: Aragon Institute of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2016
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Epigenetic Disorder
• Morbid Obesity
• Obesity
• Obesity, Morbid
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
Decision of CPAP treatment is according to clinical guidelines

Procedure:
• Bariatric Surgery
All patients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aragon Institute of Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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