Studying Infant Nutrition and Blood Sugar

Obesity Clinical Trial

Official title:

Studying Infant Nutrition and Glycemia (SING)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03524469
• Other study ID #: RSRB71535
• Secondary ID: K01DK115710
• Status: Active, not recruiting
• Start date: June 1, 2018
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity

Locations

Country	Name	City	State
United States	Clinical Research Center of the University of Rochester Medical Center	Rochester	New York

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), The Gerber Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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