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

NCT03995836 — Completed, 70 participants, Aragon Institute of Health Sciences
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Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients (EPIMOOSA): Continous Positive Airway Pressure (CPAP) and Bariatric Surgery Impact. EPIMOOSA Study

RegistryNCT03995836, acronym EPIMOOSA
StatusCompleted
Study typeObservational
Enrollment70 (Actual)
SponsorAragon Institute of Health Sciences (Other)
ConditionsObstructive Sleep Apnea, Morbid Obesity, Epigenetic Disorder
InterventionsCPAP, Bariatric Surgery (Device, procedure)
Datesstart 2014-07-01, primary completion 2016-07-01, completion 2018-07-01, first posted 2019-06-24, last updated 2019-06-24

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Obstructive Sleep ApneaDevice: CPAP; Procedure: Bariatric Surgery
Non Obstructive Sleep ApneaProcedure: Bariatric Surgery
  • CPAP (Device): Decision of CPAP treatment is according to clinical guidelines
  • Bariatric Surgery (Procedure): All patients.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

+Eligibility

Sex: All, ages: 18 Years to 60 Years

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

+Publications

  • Results publication: 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. PMID 36284205
  • Results publication: 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. PMID 32019550

+Study documents

+Investigators

  • JAVIER LAZARO SIERRA, MD, Principal investigator, Hospital Universitario Royo Villanova

My Notes