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Maternal Metabolism, Breastmilk Composition, and Transmission to Infants

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This is a pilot prospective cohort study of the differences between women with and without diabetes during pregnancy in their breast milk composition (microbiome and hormone composition), and test for group differences in the relationship of breast milk composition to infant gut microbiome characteristics, weight gain, and body composition. Women with diabetes during pregnancy (N=50) will be recruited de novo in this study, while women without diabetes (N=100) already have been enrolled and have provided consent for all necessary data involved in the comparison with the diabetic women, except that the non-diabetic women have not provided consent for the meta-genomic sequencing analysis and so will provide that consent under this protocol.

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This study is also accepting healthy volunteers
Inclusion Criteria:
(For new enrollment of 50 pregnant women with gestational diabetes and their infants. Enrollment of normal weight and obese cohort comparators already accomplished under ClinicalTrial NCT03301753):
• Pregnant women
• age 21-45 at time of delivery
• report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior), and if parity >1, that they successfully breastfed after a previous pregnancy for at least 3 months
• singleton pregnancy
• known gestational diabetes Definition of Gestational Diabetes: 1) an elevated glucose challenge test >200 mg/dL or 2) two abnormal values on the glucose tolerance test according to Carpenter-Coustan criteria.
Exclusion Criteria:

• alcohol consumption >1 drink per week during pregnancy/lactation
• tobacco consumption during pregnancy/lactation,
• inability to speak/understand English
• known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding
• planned delivery at a site other than the University of Minnesota Medical Center- West Bank campus.
• preexisting diabetes

Obesity, Diabetes, Gestational

Obesity, Gestational Diabetes, Breast Milk, Microbiome, Infant Growth

Lauren Asfaw - lasfaw@umn.edu
Ellen Demerath
Pilot
STUDY00002127
NCT03522597
See this study on ClinicalTrials.gov

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