Clinical trial NCT03995836: Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients: The EPIMOOSA Study
Official title: Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients (EPIMOOSA): Continous Positive Airway Pressure (CPAP) and Bariatric Surgery Impact. EPIMOOSA Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Morbid Obesity
Epigenetic Disorder
Keywords: Obstructive Sleep Apnea
Morbid Obesity
Epigenetics
Bariatric Surgery
Lead sponsor: Aragon Institute of Health Sciences
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bariatric surgery waiting list in Royo Villanova Hospital

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.


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

Primary outcomes:
measure: Epigenetics changes in morbid obesity patient with or without obstructive sleep apnea (OSA)
timeFrame: 2 years
Secondary outcomes:
measure: Impact of CPAP treatment in epigenetics changes.
timeFrame: 6 months
measure: Impact of weight loss due to bariatric surgery in epigenetics changes.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Royo Villanova
name: JAVIER LAZARO SIERRA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lazaro J, Sanz-Rubio D, Claveria P, Cabrejas C, Fernando J, Castanera A, Marin JM. Effect of positive pressure ventilation and bariatric surgery on extracellular vesicle microRNAs in patients with severe obesity and obstructive sleep apnea. Int J Obes (Lond). 2023 Jan;47(1):24-32. doi: 10.1038/s41366-022-01230-z. Epub 2022 Oct 25.
citation: Lazaro J, Claveria P, Cabrejas C, Fernando J, Daga B, Ordonez B, Segura S, Sanz-Rubio D, Marin JM. Epigenetics dysfunction in morbid obesity with or without obstructive sleep apnoea: the EPIMOOSA study. Respir Res. 2020 Feb 4;21(1):42. doi: 10.1186/s12931-020-1302-9.