ClinicalTrials.gov
ClinicalTrials.gov Menu

Studying Infant Nutrition and Blood Sugar

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03524469
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : July 27, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
The Gerber Foundation
Information provided by (Responsible Party):
Bridget Young, University of Rochester

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
Insulin Resistance Obesity

Study Type : Observational
Estimated Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Studying Infant Nutrition and Glycemia (SING)
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
maternal blood, stool and breast milk infant urine, stool and dried blood spot card


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03524469


Contacts
Contact: Kaili Study Coordinator 585-275-8991 BreastFeedingStudy@urmc.rochester.edu

Locations
United States, New York
Clinical Research Center of the University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Ann Miller    585-275-2907    ann_miller@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)
The Gerber Foundation

Responsible Party: Bridget Young, Research Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03524469     History of Changes
Other Study ID Numbers: RSRB71535
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases