Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
156 participants
OBSERVATIONAL
2018-06-01
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
19 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
The Gerber Foundation
OTHER
University of Rochester
OTHER
Responsible Party
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Bridget Young
Research Assistant Professor
Locations
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Clinical Research Center of the University of Rochester Medical Center
Rochester, New York, United States
Countries
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Other Identifiers
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RSRB71535
Identifier Type: -
Identifier Source: org_study_id