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OpenTrials
Completed

NCT Number: NCT03524469

Studying Infant Nutrition and Blood Sugar

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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Key information

Conditions

Insulin Resistance Body Weight Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Research Center of the University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. mean infant postprandial C peptide to creatinine ratio

    Time frame: 2 weeks

    Postprandial urine (60-90 minute) will be tested for C peptide and creatinine and the ratio will be calculated.

Secondary outcomes

  1. mean infant insulinogenic index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • The Gerber Foundation

Registry information

Official study title

Studying Infant Nutrition and Glycemia (SING)

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
May 14, 2018
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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