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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT06226194
Eligibility Criteria:
Inclusion Criteria:
* Men and women between the ages of 18 and 65 at the time of surgery
* SG or RYBP as bariatric procedure.
* With a BMI≥35.0 kg/m2 with one or more comorbidities or a BMI\>40.0 kg/m2 at the time of surgery.
* Provision of an informed consent form signed and personally dated by the patient.
* With available baseline data (anthropometric, analytical, surgical procedure, pharmacological therapies, and obesity-related comorbidities).
Exclusion Criteria:
* Any previous gastrointestinal surgery
* Treatment with any approved antiobesity drug in Spain (orlistat, liraglutide 3.0 mg and/or naltrexone/bupropion extended release) or systemic glucocorticoids for more than 4 consecutive weeks during the 3 years following BS
* End stage kidney disease (eGFR \<15 ml/min/1.73m2) or liver cirrhosis at baseline
* Patients who developed any major medical conditions that limits the practice of a healthy life within normal limits (advanced cardiovascular disease or heart failure, stroke with neurological sequelae, chronic pulmonary obstructive disease with dyspnea at minimal exertion, severe joint pathology, end stage renal failure, or active cancer)
* Known type 1 diabetes or LADA diabetes
* Women who become pregnant during the follow-up period
* Current drug or alcohol abuse
* Uncontrolled psychiatric illness or eating disorders developed during the follow-up period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06226194
Study Brief:
Protocol Section:
NCT06226194