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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT03524469
Eligibility Criteria:
Inclusion Criteria:
* Mothers ≥ 19 years of age
* Mothers intending to Exclusively Breastfeed for at least 5months
* Mothers comfortable with feeding their infants expressed breast milk from a bottle at 2-weeks postpartum
* Trial of labor (no scheduled C-sections)
* Singleton birth
* Healthy Infants
* "Normal Weight" will be defined as pre-pregnant BMI between 18.5-23.9 kg/m2 and passing the 28 week oral glucose tolerance test.
* "Insulin Resistance" will be defined as meeting any of the following:
* pre-pregnant BMI ≥ 28 and failed the 28 week oral glucose screening test
* pre-pregnant BMI ≥ 28 and diagnosis of either A1 ("diet controlled") or A2 ("insulin-requiring") gestational diabetes during pregnancy, but insulin therapy discontinued after birth.
* pre-pregnant BMI ≥ 28 and diagnosed with type 2 diabetes during pregnancy
* pre-pregnant BMI ≥ 30, and unmediated.
Exclusion Criteria:
* Scheduled C-sections or emergency C-sections with no labor (natural or induced)
* Maternal insulin therapy after birth
* Significant maternal health concern including type 1 diabetes, renal, kidney, thyroid, or cardiovascular disease, pre-eclampsia, or other disease.
* Delivery before 37 weeks
* Infant birth weight \<2500g
* Infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns
* Infant supplementation with infant formula (glucose gel or donor milk is acceptable)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03524469
Study Brief:
Protocol Section:
NCT03524469