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

Obesity Clinical Trial

— MIG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693406
• Other study ID #: 12-0629
• Status: Completed
• Start date: August 2012
• Est. completion date: September 2020

Study information

• Verified date: November 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: September 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Obesity
• Type 2 Diabetes

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Diabetes Association, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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