Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers (MIG)
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. Our 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. We 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. We will track infant weight and fat gain and monitor maternal glucose control. We 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. We 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. We expect these differences will be most pronounced in the first 2 weeks after birth. We also predict that breast milk concentrations of these biomarkers will be associated with infant fat gain. What we find will help us understand how early infant nutrition and growth may affect that child's later risk of obesity.
Type 2 Diabetes
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Breast Milk and Infant Growth and Body Composition Among Healthy Mothers, Obese Mothers, and Mothers With Diabetes|
- Change in infant percent body fat from birth to 4 months [ Time Frame: Birth, 2 weeks, 1, 2, 3, and 4 month ] [ Designated as safety issue: No ]Body composition is measured by skin folds and air displacement plethysmography (PeaPod)
- Human Milk Hormone Composition [ Time Frame: 2 weeks, 1, 2, 3, and 4 months ] [ Designated as safety issue: No ]We will analyze: insulin, leptin, adiponectin, and ghrelin concentrations in human milk samples collected at these time points
- Human Milk cytokine content [ Time Frame: 2 weeks, 1, 2, 3, and 4 months ] [ Designated as safety issue: No ]We will analyze: IL-10, IL-6, IL-8, and TNF-alpha concentrations in human milk samples collected at these time points
- Antioxidant capacity of human milk [ Time Frame: 2 weeks, 1, 2, 3, and 4 months ] [ Designated as safety issue: No ]We will analyze: TBARS, 8-OH-dG, HNE, and F2-isoprostane concentrations and total antioxidant capacity in human milk samples collected at these time points.
- Human Milk Nutrient Composition [ Time Frame: 2 weeks, 1, 2, 3, and 4 months ] [ Designated as safety issue: No ]We will analyze: glucose, percent fat, protein and caloric content of human milk samples collected at these time points.
Biospecimen Retention: Samples Without DNA
Human Milk, Plasma, Urine and Stool
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Normal weight and normoglycemic women: Pre-pregnancy BMI between 18.5 - 24.9 kg/m2.
Overweight and normoglycemic women: Pre-pregnancy BMI between > 25 kg/m2.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693406
|Contact: Bridget E Young, PhD||(303)724-3309||Bridget.Young@UCDenver.edu|
|United States, Colorado|
|University of Colorado Anschutz Medical Campus||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Bridget E Young, PhD 303-724-3309 Bridget.Young@UCDenver.edu|
|Principal Investigator: Nancy F Krebs, MD, MS|
|Principal Investigator: Linda A Barbour, MD, MSPH|
|Principal Investigator:||Nancy F Krebs, MD, MS||University of Colorado, Denver|
|Principal Investigator:||Linda A Barbour, MD, MSPH||University of Colorado, Denver|