Skip to main content
OpenTrials
Completed

NCT Number: NCT01693406

Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Change in Human Milk Hormone Composition

    Time frame: 2 weeks, 1, 2, 3, and 4 months

    The investigators will analyze: insulin, leptin, adiponectin, and ghrelin concentrations in human milk samples collected at these time points

  2. Change in Human Milk cytokine content

    Time frame: 2 weeks, 1, 2, 3, and 4 months

    The investigators will analyze: IL-10, IL-6, IL-8, and TNF-alpha concentrations in human milk samples collected at these time points

  3. Change in Antioxidant capacity of human milk

    Time frame: 2 weeks, 1, 2, 3, and 4 months

    The investigators will analyze: TBARS, 8-OH-dG, HNE, and F2-isoprostane concentrations and total antioxidant capacity in human milk samples collected at these time points.

Other outcomes

  1. Change in Human Milk Nutrient Composition

    Time frame: 2 weeks, 1, 2, 3, and 4 months

    The investigators will analyze: glucose, percent fat, protein and caloric content of human milk samples collected at these time points.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • American Diabetes Association
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Thrasher Research Fund

Registry information

Official study title

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

Acronym: MIG

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2012
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.