Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers (MIG)

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Type 2 Diabetes; Gestational Diabetes

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

We will recruit pregnant women in the Denver Colorado area who plan to deliver their infant at the University of Colorado Hospital, and plan to exclusively breastfeed their infant for at least 5 months.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Normal Weight; Normal weight and normoglycemic women: Pre-pregnancy BMI between 18.5 - 24.9 kg/m2.
Overweight/Obese; Overweight and normoglycemic women: Pre-pregnancy BMI between > 25 kg/m2.
Gestational Diabetes; Women who develop gestational diabetes and return to normal glucose control after delivery.
Type 2 Diabetes; Women who are overweight and have Type 2 Diabetes that was diagnosed before pregnancy: Pre-pregnancy BMI > 25 kg/m2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in infant percent body fat from birth to 4 months	Body composition is measured by skin folds and air displacement plethysmography (PeaPod)	Birth, 2 weeks, 1, 2, 3, and 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Human Milk Hormone Composition	The investigators will analyze: insulin, leptin, adiponectin, and ghrelin concentrations in human milk samples collected at these time points	2 weeks, 1, 2, 3, and 4 months
Change in Human Milk cytokine content	The investigators will analyze: IL-10, IL-6, IL-8, and TNF-alpha concentrations in human milk samples collected at these time points	2 weeks, 1, 2, 3, and 4 months
Change in Antioxidant capacity of human milk	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.	2 weeks, 1, 2, 3, and 4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Human Milk Nutrient Composition	The investigators will analyze: glucose, percent fat, protein and caloric content of human milk samples collected at these time points.	2 weeks, 1, 2, 3, and 4 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); American Diabetes Association; Thrasher Research Fund
• Investigators: Principal Investigator: Linda A Barbour, MD, MSPH, University of Colorado, Denver; Principal Investigator: Nancy F Krebs, MD, MS, University of Colorado, Denver

Publications and helpful links

General Publications

• Lemas DJ, Young BE, Baker PR 2nd, Tomczik AC, Soderborg TK, Hernandez TL, de la Houssaye BA, Robertson CE, Rudolph MC, Ir D, Patinkin ZW, Krebs NF, Santorico SA, Weir T, Barbour LA, Frank DN, Friedman JE. Alterations in human milk leptin and insulin are associated with early changes in the infant intestinal microbiome. Am J Clin Nutr. 2016 May;103(5):1291-300. doi: 10.3945/ajcn.115.126375.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: September 21, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 26, 2012

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: diabetes; obesity; breastfeeding; human milk; infant growth
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 12-0629