Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
NCT ID:
NCT03530566
Eligibility Criteria:
Inclusion Criteria:
* Patients of both sexes, between 18 and 65 years old
* Patients with morbid obesity (BMI ≥ 40 kg/m2) or with severe obesity (BMI 35 to 39.9 kg/m2), with two or more comorbidities associated with obesity (type 2 diabetes mellitus, arterial hypertension, obstructive sleep apnea, obesity hypoventilation syndrome, chronic respiratory disease, metabolic syndrome, atrial fibrillation, heart failure, pulmonary hypertension, cardiomyopathy, history of thrombosis, renal failure).
* Patients scheduled for bariatric surgery within 3 months ± 1 week.
* Patients who, regardless of their inclusion in this study, will undergo treatment with the multidisciplinary slimming program in study or standard diet.
* Patients who agree to participate and sign the Informed Consent
Exclusion Criteria:
* Pregnant or lactating women.
* Patients with type 1 diabetes mellitus or on insulin therapy
* Patients with eating disorders, alcoholism, and/or drug addiction.
* Patients with any severe psychological disorder (eg schizophrenia, bipolar disorder).
* Patients receiving dicumarinic anticoagulants (Sintrom®) or cortisone.
* Patients with liver failure.
* Patients with severe kidney failure (gfr \<30).
* Patients with hemopathies.
* Patients with cancer.
* Patients with cardiovascular or cerebrovascular disease (heart rate disorders, recent infarction \[\<6m\], unstable angina, decompensated heart failure, recent stroke \[\<6m\]).
* Patients in acute attack of gout.
* Patients with renal lithiasis verified by ultrasound.
* Patients with cholelithiasis verified by ultrasound.
* Patients with depression.
* Patients with electrolyte imbalance, according to medical criteria.
* Patients with orthostatic hypotension.
* Patients with contraindications to surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03530566
Study Brief:
Protocol Section:
NCT03530566