Clinical trial NCT03524469: Studying Infant Nutrition and Blood Sugar
Official title: Studying Infant Nutrition and Glycemia (SING)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Insulin Resistance
Obesity
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: The Gerber Foundation
First posted: 2018-05-14
Enrollment: 156
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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)

Primary outcomes:
measure: mean infant postprandial C peptide to creatinine ratio
timeFrame: 2 weeks
Secondary outcomes:
measure: mean infant insulinogenic index
timeFrame: 5 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Clinical Research Center of the University of Rochester Medical Center
state: New York
Study officials:
References: