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Clinical Trials/NCT01693406
NCT01693406
Completed
Not Applicable

Breast Milk and Infant Growth and Body Composition Among Healthy Mothers, Obese Mothers, and Mothers With Diabetes

University of Colorado, Denver1 site in 1 country59 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Colorado, Denver
Enrollment
59
Locations
1
Primary Endpoint
Change in infant percent body fat from birth to 4 months
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Childhood obesity is a critical global public health concern. Breastfeeding is the ideal choice for infant nutrition. However, rapid and excess weight gain during infancy predicts later, even among breastfed infants. This risk is higher if mothers are obese and/or diabetic. Composition of bioactive components of breast milk may differ based between mothers who are normal weight (NW), overweight, or who have diabetes. Obesity and Type 2 Diabetes are associated with overall increases in inflammation and oxidative stress, but how breast milk composition is affected remains unknown. The investigators overarching goal is to determine how maternal obesity and Type 2 Diabetes impacts human breast milk composition and how differences in composition may impact infant growth and fat development. The investigators are undertaking a study that follows 20 Normal Weight, 20 Obese, 20 Gestational Diabetic, and 20 Type 2 Diabetic mothers and their infants over the first 4 months of life. The investigators will track infant weight and fat gain and monitor maternal glucose control. The investigators will also collect breast milk samples over the first 4 months and measure concentrations of growth and appetite hormones, cytokines, markers of oxidative stress and nutrient composition in milk. The investigators predict that concentrations of growth-regulatory hormones (insulin and leptin) in addition to the inflammatory cytokines and markers of oxidative stress will be lowest in breast milk from NW mothers, higher in breast milk from obese and gestational diabetic mothers, and highest in Type 2 Diabetic mothers' breast milk. The investigators expect these differences will be most pronounced in the first 2 weeks after birth. The investigators also predict that breast milk concentrations of these biomarkers will be associated with infant fat gain. What the investigators find will help understand how early infant nutrition and growth may affect that child's later risk of obesity.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
September 2020
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Between 28-40 weeks gestation
  • Plan to Exclusively Breastfeed for at least 5 months
  • Between 20 - 35 years old
  • Carrying a singleton pregnancy
  • Parity less than or equal to 5
  • Pre-pregnancy BMI between 18.5 and 39.9

Exclusion Criteria

  • No known infant anomalies or birth defects
  • Maternal Type 1 Diabetes
  • Maternal major medical condition (ie: Kidney Disease or Pre-eclampsia)
  • Delivery of the infant before 35 weeks gestation
  • Smoking During pregnancy

Outcomes

Primary Outcomes

Change in infant percent body fat from birth to 4 months

Time Frame: Birth, 2 weeks, 1, 2, 3, and 4 months

Body composition is measured by skin folds and air displacement plethysmography (PeaPod)

Secondary Outcomes

  • Change in Human Milk cytokine content(2 weeks, 1, 2, 3, and 4 months)
  • Change in Human Milk Hormone Composition(2 weeks, 1, 2, 3, and 4 months)
  • Change in Antioxidant capacity of human milk(2 weeks, 1, 2, 3, and 4 months)

Study Sites (1)

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