Studying Infant Nutrition and Blood Sugar

University of Rochester

Status: Active, not recruiting

Conditions: Insulin Resistance; Obesity

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03524469

K01DK115710 (U.S. NIH Grant/Contract)

RSRB71535

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

128 participants in 2 patient groups

Normal weight

Description:

"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 resistant

Description:

"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.