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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT02792166
Eligibility Criteria:
Inclusion Criteria:
Participants must meet ALL of the following inclusion criteria:
* Age ≥18 years and ≤60 years
* Fulfill criteria for bariatric surgery as coined by National Institutes of Health
* Give written informed consent
Exclusion Criteria:
Participants who meet any of the following criteria at the time of the baseline visit are excluded from the study:
* Presence of the following baseline comorbidities:
* Congestive heart failure (CHF),
* Chronic kidney disease (CKD) stage 3-5 (or GFR \<60 ml/min per 1.73 m2),
* Inflammatory bowel disease (IBD),
* Pulmonary hypertension (PHTN),
* Cirrhosis.
* Severe gastroesophageal reflux disorder (GERD) +/- presence of any Barrett's disease
* Individuals who were found by any member of the multidisciplinary team (nutritionist, nurse, psychologist, and surgeon) to be at risk for lack of support and poor compliance (e.g. ≥2 missed appointments without a valid justification)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02792166
Study Brief:
Protocol Section:
NCT02792166