Metabolism, Breastmilk, and Microbiome

NCT03522597 | Completed

• 2 other identifiers: OBGYN-2018-26409R01HD080444
• Study Type: observational
• Target: 2,050
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot study is to compare breast milk composition in mothers of three different metabolic states (normal weight, obese, and gestational diabetic) and to determine the extent to which breastmilk components are transmitted to the infant gut and are associated with the anthropometric and body composition changes in their infants during the first 6 months of life. It is hypothesized that 1) different maternal metabolic states will be associated with differences in breastmilk microbial communities and breastmilk biochemical features, 2) differences in these breastmilk biomarkers will be transmitted to infants and 3) breastmilk microbial and metabolic features will be associated with infant growth outcomes.

Conditions

Obesity; Diabetes, Gestational

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Breastmilk and infant microbiomes

  Change in the diversity and abundance of breast milk and infant gut bacterial and fungal species and strains, and functional microbiome profiles

  1, 3, and 6 months postpartum

Secondary Outcomes (3)

• Hormones in breastmilk

  1 and 3 months postpartum

• Hormones and cytokines in maternal serum

  At time of delivery (time 0)

• Hormones and cytokines in infant serum

  At time of delivery (time 0) and 6 months postpartum

Study Arms (3)

Normal weight

Normal weight (BMI) women and their infants

Obese

Obese (BMI) women and their infants

Diabetic

Women with gestational diabetes and their infants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

(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) Recruitment of women with gestational diabetes will be conducted at the University of Minnesota Medical Center (UMMC) Department of Obstetrics, Gynecology, and Women's Health, Division of Maternal Fetal Medicine and Women's Health Specialists Clinics (Minneapolis, MN) during an antenatal clinic visit.

You may qualify if:

• (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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• University of Oklahoma: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Maternal serum and breast milk, infant feces.

MeSH Terms

Conditions

Obesity; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Cheryl A Gale, M.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Ellen W Demerath, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: May 11, 2018
• Study Start: June 1, 2018
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)