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 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT03713060
Eligibility Criteria:
Inclusion Criteria:
* GB group: pregnant women with RYGB (n = 20)
* non-GB group: pregnant women matched on age, prepregnancy-BMI and parity (n = 20)
* neonates: offspring of abovementioned women (n = 40)
Exclusion Criteria:
* multiple pregnancy
* age below 18 and above 45 years
* ongoing smoking and substance abuse
* severe psychiatric disorder
* severe chronic disease
* diabetes
* women with overt diabetes at inclusion (HbA1c ≥ 48 mmol/l and/or fasting p-glucose ≥ 7 mmol/l)
* women with pre-gestational diabetes (type1 or 2) prior to RYGB
* women with Gestational Diabetes Mellitus (GDM) in a previous pregnancy will not be excluded
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03713060
Study Brief:
Protocol Section:
NCT03713060