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 @ 1:16 PM
Ignite Modification Date:
2025-12-24 @ 1:16 PM
NCT ID:
NCT01307995
Eligibility Criteria:
Inclusion Criteria:
* age above 18 years old
* GDM diagnosed according to WHO guidelines (GDM group) or ruled out by OGTT 75g (Control group)
Exclusion Criteria:
* Previous diagnosis of DM
* Positive GAD-65-autoantibodies and/or positive islet cell autoantibodies (ICA)
* Affected biochemical liver parameters (ALAT \> 2 times normal upper range)
* Affected biochemical kidney parameters (se-creatinine \> 130 µM)
* Treatment with medicine interacting with insulin secretion (e.g. steroids)
* Treatment with medicine that can not be paused for 16 hours
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01307995
Study Brief:
Protocol Section:
NCT01307995