Studying Infant Nutrition and Blood Sugar

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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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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