Studying Infant Nutrition and Blood Sugar
Completed
Conditions studied: Insulin Resistance, Obesity
In brief
The purpose of this study is to learn about how breast milk from mothers with insulin-resistance may be different. Investigators are specifically studying insulin concentrations in breast milk. Investigators are also studying how insulin in breast milk might affect a baby's intestines and pancreas.
Key facts
- Study ID
- NCT03524469
- Run by
- University of Rochester
- People needed
- 156
- Starts
- 2018-06-01
- Expected to finish
- 2024-12-01
- Last updated by the study team
- 2024-12-31
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Clinical Research Center of the University of Rochester Medical Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.