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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03995836
Other study ID # 23/2014
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2014
Est. completion date July 1, 2018

Study information

Verified date June 2019
Source Aragon Institute of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date July 1, 2018
Est. primary completion date July 1, 2016
Accepts healthy volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Device:
CPAP
Decision of CPAP treatment is according to clinical guidelines
Procedure:
Bariatric Surgery
All patients.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aragon Institute of Health Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Impact of CPAP treatment in epigenetics changes. 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
Secondary Impact of weight loss due to bariatric surgery in epigenetics changes. 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
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