Studying Infant Nutrition and Blood Sugar

Completed

• Conditions: Insulin Resistance; Obesity

• Registration Number: NCT03524469
• Lead Sponsor: University of Rochester

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-02
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-14
• Study Start: 2018-06-01
• Primary Completion: 2023-06-01
• Status Verified: 2024-12
• Study Completion: 2024-12-01
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mean infant postprandial C peptide to creatinine ratio	2 weeks	Postprandial urine (60-90 minute) will be tested for C peptide and creatinine and the ratio will be calculated.

Secondary Outcome Measures

Name	Time	Method
mean infant insulinogenic index	5 months	The insulinogenic index will be measures in infant blood at 0 and 30 minutes post glucose administration. The index is the change in insulin over the change in glucose.

Trial Locations

Locations (1)

Clinical Research Center of the University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States