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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT04813003
Eligibility Criteria:
Inclusion criteria (all participants):
* Female and male subjects aged 18 years or older
* Proficient German language skills (including written)
Inclusion criteria for Group 1 (pilot protocol):
* Class II-III obesity (BMI≥35kg/m2)
* Planned for bariatric surgery (Roux-en-Y gastric bypass)
Inclusion criteria for Group 1 (refined protocol):
* BMI≥30kg/m2 or BMI≥28kg/m2 with adiposity-related comorbidities (prediabetes, type 2 diabetes mellitus, hypertension, dyslipidemia)
* Referred for obesity treatment (surgical or non-surgical)
Inclusion criteria for Group 2 (pilot and refined protocols):
* Normal body weight (BMI 18.5-24.9kg/m2)
* Absence of evidence of any active or chronic disease as judged by the Clinical Investigator
Exclusion criteria:
* Incapacity to give informed consent
* Previous or current neurological or severe psychiatric illness
* Current or planned pregnancy or breastfeeding
* Claustrophobia
* MRI-contraindications (pacemaker/defibrillator, neurostimulator, drug pump, cochlear implant, heart valve/vascular clips, shunt valve)
* Pilot protocol only: Diabetes according to WHO (World Health Organization ) definition (Fasting plasma glucose ≥7.0mmol/l, random plasma glucose ≥11.1mmol/l, HbA1c ≥6.5%)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04813003
Study Brief:
Protocol Section:
NCT04813003