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| ID | Type | Description | Link |
|---|---|---|---|
| K01DK115710 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| The Gerber Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal weight | "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 | "Insulin Resistance" will be defined as meeting any of the following:
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| 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 |
| 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 |
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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:
Exclusion Criteria:
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The inclusion criteria were selected to include only healthy infants of uncomplicated pregnancy (with the exception of gestational diabetes) and normal birth weight. The criteria for insulin resistance were strategically defined to capture the insulin-resistant population which represents a large proportion of the population that are at risk for diabetes but have not yet developed the disease. Insulin therapy is an exclusion criteria because it passes through the breast milk and we are unable to distinguish endogenous maternal insulin from exogenous therapeutic insulin in breast milk samples. These criteria will minimize the risks and increase the safety of subjects.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center of the University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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maternal blood, stool and breast milk infant urine, stool and dried blood spot card
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |