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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT06850493
Eligibility Criteria:
Inclusion Criteria:
* Eligible for bariatric surgery (≥35 kg/m2 with obesity-related comorbidities, or a BMI of
* 40 kg/m2 with or without comorbidities)
* Roux-en-Y Gastric bypass (RYGB)
Exclusion Criteria:
* Weighing over 150kg because this amount is a limitation by the DXA device
* Diabetes mellitus type 1
* Allergic to milk proteins
* A recent history of a heart attack (\< 12 months), heart failure or cardiac arrhythmias
* Kidney and/or liver failure (creatinine levels \>1.3 mg/dl or liver enzyme levels (AST, ALT, GGT)) less than three times over the upper normal threshold
* Current infectious, sepsis or malignant disease
* Rare condition like galactosemia, phenylketonuria or porphyria
* Persistent diarrhoea
* Hypokalaemia, chronic therapies with diuretics as furosemide and hydrochlorothiazide
* Pregnancy or plans to get pregnant in the coming months
* Patients who did not meet criteria to be eligible for bariatric surgery (BMI \<35, psychological or unstable psychiatric disorders, inadequate dietary regimen or inadequate exercise pattern which can't be resolved in the upcoming 6 months)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06850493
Study Brief:
Protocol Section:
NCT06850493