NCT03524469Completed
Studying Infant Nutrition and Blood Sugar
Studying Infant Nutrition and Glycemia (SING)
Source: ClinicalTrials.gov · Last updated 31 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 156 (actual)
- First submitted
- 2 May 2018
- Start date
- 1 Jun 2018
- Primary completion date
- 1 Jun 2023
- Lead sponsor
- University of Rochester
- Diseases
- Obesity
- NCT number
- NCT03524469
What you commit to
- Study type: Observational
- Participants enrolled: 156
- From 1 Jun 2018 to the primary completion date, 1 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Maternal insulin therapy after birth
Other illness
- Significant maternal health concern including type 1 diabetes, renal, kidney, thyroid, or cardiovascular disease, pre-eclampsia, or other disease.
Lab values
- Infant supplementation with infant formula (glucose gel or donor milk is acceptable)
Other
- Scheduled C-sections or emergency C-sections with no labor (natural or induced)
- Delivery before 37 weeks
- Infant birth weight \<2500g
- Infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Center of the University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.