Clinical trial NCT01693406: Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers
Official title: Breast Milk and Infant Growth and Body Composition Among Healthy Mothers, Obese Mothers, and Mothers With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Type 2 Diabetes
Gestational Diabetes
Keywords: human milk
infant growth
obesity
diabetes
breastfeeding
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Thrasher Research Fund
name: American Diabetes Association
First posted: 2012-09-26
Enrollment: 59
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Change in infant percent body fat from birth to 4 months
timeFrame: Birth, 2 weeks, 1, 2, 3, and 4 months
Secondary outcomes:
measure: Change in Human Milk Hormone Composition
timeFrame: 2 weeks, 1, 2, 3, and 4 months
measure: Change in Human Milk cytokine content
timeFrame: 2 weeks, 1, 2, 3, and 4 months
measure: Change in Antioxidant capacity of human milk
timeFrame: 2 weeks, 1, 2, 3, and 4 months
Other outcomes:
measure: Change in Human Milk Nutrient Composition
timeFrame: 2 weeks, 1, 2, 3, and 4 months
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Nancy F Krebs, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Linda A Barbour, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.