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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT01352403
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* BMI \>40 kg/m2 or BMI \>35 kg/m2 with severe comorbidities
* Indication for Roux-en-Y gastric bypass surgery
* Ability to perform cardiopulmonary exercise testing (CPET)
* Written informed consent
Exclusion Criteria:
* Pregnancy or breast feeding
* Unstable angina pectoris
* Life expectancy \<12 months
* Endocrine or psychiatric disorder as cause of obesity
* Systemic glucocorticoid treatment (with exception of glucocorticoid replacement therapy)
* Abuse of drugs or alcohol within the last 5 years
* Inability to attend regular study visits for logistic reasons
* Participation in competing trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01352403
Study Brief:
Protocol Section:
NCT01352403