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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07434557
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18-65 years
* History of metabolic bariatric surgery
* At least 5 years post-surgery
* Individuals presenting either:
recurrent weight gain after initial successful weight loss, or insufficient weight loss defined as nadir percent total weight loss (%TWL nadir) \<20%.
Recurrent weight gain (RWG) was defined according to IFSO consensus recommendations. RWG (%) was calculated as:
RWG (%) = (weight regained / maximum weight loss) × 100
Participants were categorized using a cut-off value of 30% (RWG ≥30% vs. \<30%).
Exclusion Criteria:
* Pregnant or breastfeeding individuals
* Acute illness or active infection
* Medical conditions limiting study safety (e.g., cancer, type 1 diabetes, renal or hepatic failure, recent stroke or myocardial infarction, nephrolithiasis, substance abuse, eating disorders, severe depression or other major psychiatric disorders, inflammatory bowel disease, neoplasia, cardiac arrhythmia, heart failure, respiratory failure, or systemic corticosteroid therapy)
* Professional athletes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07434557
Study Brief:
Protocol Section:
NCT07434557