Studying Infant Nutrition and Blood Sugar

Study Overview
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Brief Summary
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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.

Official Title
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Studying Infant Nutrition and Glycemia (SING)

Conditions
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Insulin Resistance, Obesity

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal weight<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean infant postprandial C peptide to creatinine ratio | Postprandial urine (60-90 minute) will be tested for C peptide and creatinine and the ratio will be calculated. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean infant insulinogenic index | 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. | 5 months |