- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03995836
Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients: The EPIMOOSA Study (EPIMOOSA)
Epigenetics Modifications in Morbid Obesity and Obstructive Sleep Apnea Patients (EPIMOOSA): Continous Positive Airway Pressure (CPAP) and Bariatric Surgery Impact. EPIMOOSA Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Obstructive Sleep Apnea
|
Decision of CPAP treatment is according to clinical guidelines
All patients.
|
Non Obstructive Sleep Apnea
|
All patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
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. |
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: JAVIER LAZARO SIERRA, MD, Hospital Royo Villanova
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23/2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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