Epigenetic Disorder, Morbid Obesity, Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep Apnea, Morbid Obesity, Epigenetics, Bariatric Surgery
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.
Interventions
DEVICECPAP
Decision of CPAP treatment is according to clinical guidelines
PROCEDUREBariatric Surgery
All patients.
Sponsors
Aragon Institute of Health Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed