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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995836
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Aragon Institute of Health Sciences

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.


Condition or disease Intervention/treatment
Obstructive Sleep Apnea Morbid Obesity Epigenetic Disorder Device: CPAP Procedure: Bariatric Surgery

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients (EPIMOOSA): Continous Positive Airway Pressure (CPAP) and Bariatric Surgery Impact. EPIMOOSA Study
Actual Study Start Date : July 1, 2014
Actual Primary Completion Date : July 1, 2016
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Obstructive Sleep Apnea Device: CPAP
Decision of CPAP treatment is according to clinical guidelines

Procedure: Bariatric Surgery
All patients.

Non Obstructive Sleep Apnea Procedure: Bariatric Surgery
All patients.




Primary Outcome Measures :
  1. Epigenetics changes in morbid obesity patient with or without obstructive sleep apnea (OSA) [ Time Frame: 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 Outcome Measures :
  1. Impact of CPAP treatment in epigenetics changes. [ Time Frame: 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.

  2. Impact of weight loss due to bariatric surgery in epigenetics changes. [ Time Frame: 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.



Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Bariatric surgery waiting list in Royo Villanova Hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995836


Sponsors and Collaborators
Aragon Institute of Health Sciences
Investigators
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Principal Investigator: JAVIER LAZARO SIERRA, MD Hospital Royo Villanova
  Study Documents (Full-Text)

Documents provided by Aragon Institute of Health Sciences:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aragon Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT03995836    
Other Study ID Numbers: 23/2014
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aragon Institute of Health Sciences:
Obstructive Sleep Apnea
Morbid Obesity
Epigenetics
Bariatric Surgery
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases