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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT02763267
Eligibility Criteria:
Inclusion Criteria:
* Women, age 18-44, non-pregnant OR in the 1st trimester of pregnancy (4-14 weeks gestation),
* Who had GDM in a previous pregnancy
* At risk for diabetes mellitus, as specified by the American Diabetes Association (ADA):
* BMI ≥ 25 kg/m2 (or BMI ≥ 23 kg/m2 if Asian-American) PLUS one or more of the following:
* history of giving birth to a neonate weighing \> 9 lbs
* first-degree family member with diabetes mellitus
* high-risk ethnic or racial group (African-American, Hispanic, Native American, Asian-American, or Pacific Islander)
* polycystic ovary syndrome
* hypertension, dyslipidemia if known (HDL\<45 and/or triglyceride level \>250), or cardiovascular disease
* physical inactivity
Exclusion Criteria:
* Known pre-existing diabetes mellitus, based on patient report or medical record review
* A1C ≥ 6.5%, detected at study visit 1
* Use of medications known to affect glucose tolerance including corticosteroids, metformin, sulfonylureas, and others as determined by the investigators.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
44 Years
Study:
NCT02763267
Study Brief:
Protocol Section:
NCT02763267