Studying Infant Nutrition and Blood Sugar

Studying Infant Nutrition and Glycemia (SING)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Insulin Resistance

• Study Type: Observational
• Enrollment (Estimated): 128

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Clinical Research Center of the University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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: 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?

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

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institutes of Health (NIH); The Gerber Foundation

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 1, 2022
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: RSRB71535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No