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

NCT01693406 | Completed

• 1 other identifier: 12-0629
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes; Gestational Diabetes

Keywords

human milk; infant growth; obesity; diabetes; breastfeeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Human Milk Hormone Composition

  2 weeks, 1, 2, 3, and 4 months

• Change in Human Milk cytokine content

  2 weeks, 1, 2, 3, and 4 months

• Change in Antioxidant capacity of human milk

  2 weeks, 1, 2, 3, and 4 months

Other Outcomes (1)

• Change in Human Milk Nutrient Composition

  2 weeks, 1, 2, 3, and 4 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Thrasher Research Fund: collaborator
• American Diabetes Association: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• Odiase E, Frank DN, Young BE, Robertson CE, Kofonow JM, Davis KN, Berman LM, Krebs NF, Tang M. The Gut Microbiota Differ in Exclusively Breastfed and Formula-Fed United States Infants and are Associated with Growth Status. J Nutr. 2023 Sep;153(9):2612-2621. doi: 10.1016/j.tjnut.2023.07.009. Epub 2023 Jul 26.

  PMID: 37506974 DERIVED

• 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.

  PMID: 27140533 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human Milk, Plasma, Urine and Stool

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Diabetes, Gestational; Diabetes Mellitus; Breast Feeding

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• Nancy F Krebs, MD, MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Linda A Barbour, MD, MSPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: September 26, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

US (1)