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

NCT03995836 | Completed

• 1 other identifier: 23/2014
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea; Morbid Obesity; Epigenetic Disorder

Keywords

Obstructive Sleep Apnea; Morbid Obesity; Epigenetics; Bariatric Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Impact of CPAP treatment in epigenetics changes.

  6 months

• Impact of weight loss due to bariatric surgery in epigenetics changes.

  12 months

Study Arms (2)

Obstructive Sleep Apnea

Device: CPAP; Procedure: Bariatric Surgery

Non Obstructive Sleep Apnea

Procedure: Bariatric Surgery

Interventions

CPAP DEVICE

Decision of CPAP treatment is according to clinical guidelines

Obstructive Sleep Apnea

Bariatric Surgery PROCEDURE

All patients.

Non Obstructive Sleep Apnea; Obstructive Sleep Apnea

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Bariatric surgery waiting list in Royo Villanova Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aragon Institute of Health Sciences: lead

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• JAVIER LAZARO SIERRA, MD

  Hospital Royo Villanova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: June 24, 2019
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2018
• Last Updated: June 24, 2019

Record last verified: 2019-06