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出境医 / 临床实验 / Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients: The EPIMOOSA Study (EPIMOOSA)

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

Study Description
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

Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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

Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Sponsors and Collaborators
Aragon Institute of Health Sciences
Investigators
Layout table for investigator information
Principal Investigator: JAVIER LAZARO SIERRA, MD Hospital Royo Villanova
Tracking Information
First Submitted Date May 13, 2019
First Posted Date June 24, 2019
Last Update Posted Date June 24, 2019
Actual Study Start Date July 1, 2014
Actual Primary Completion Date July 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 20, 2019) 		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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 20, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population Bariatric surgery waiting list in Royo Villanova Hospital
Condition
  • Obstructive Sleep Apnea
  • Morbid Obesity
  • Epigenetic Disorder
Intervention
  • Device: CPAP
    Decision of CPAP treatment is according to clinical guidelines
  • Procedure: Bariatric Surgery
    All patients.
Study Groups/Cohorts
  • Obstructive Sleep Apnea
    Interventions:
    • Device: CPAP
    • Procedure: Bariatric Surgery
  • Non Obstructive Sleep Apnea
    Intervention: Procedure: Bariatric Surgery
Publications * Lázaro J, Clavería P, Cabrejas C, Fernando J, Daga B, Ordoñez B, Segura S, Sanz-Rubio D, Marín 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2019) 		70
Original Actual Enrollment Same as current
Actual Study Completion Date July 1, 2018
Actual Primary Completion Date July 1, 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03995836
Other Study ID Numbers 23/2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Aragon Institute of Health Sciences
Study Sponsor Aragon Institute of Health Sciences
Collaborators Not Provided
Investigators
Principal Investigator: JAVIER LAZARO SIERRA, MD Hospital Royo Villanova
PRS Account Aragon Institute of Health Sciences
Verification Date June 2019

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