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Studying Infant Nutrition and Blood Sugar

Sponsor
University of Rochester (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03524469
Collaborator
National Institutes of Health (NIH) (NIH), The Gerber Foundation (Other)
128
Enrollment
1
Location
53
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    128 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Studying Infant Nutrition and Glycemia (SING)
    Actual Study Start Date :
    Jun 1, 2018
    Actual Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Nov 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Center of the University of Rochester Medical Center Rochester New York United States 14642

    Sponsors and Collaborators

    • University of Rochester
    • National Institutes of Health (NIH)
    • The Gerber Foundation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bridget Young, Research Assistant Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT03524469
    Other Study ID Numbers:
    • RSRB71535
    First Posted:
    May 14, 2018
    Last Update Posted:
    Jun 10, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Insulin Resistance

    Study Results

    No Results Posted as of Jun 10, 2022