Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers (MIG)
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Purpose
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.
| Condition |
|---|
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Obesity Type 2 Diabetes Gestational Diabetes |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 160 |
| 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) |
| Groups/Cohorts |
|---|
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Normal Weight
Normal weight and normoglycemic women: Pre-pregnancy BMI between 18.5 - 24.9 kg/m2.
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Overweight/Obese
Overweight and normoglycemic women: Pre-pregnancy BMI between > 25 kg/m2.
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Gestational Diabetes
Women who develop gestational diabetes and return to normal glucose control after delivery.
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Type 2 Diabetes
Women who are overweight and have Type 2 Diabetes that was diagnosed before pregnancy: Pre-pregnancy BMI > 25 kg/m2.
|
Eligibility| Ages Eligible for Study: | 20 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01693406 History of Changes |
| Other Study ID Numbers: | 12-0629 |
| Study First Received: | September 21, 2012 |
| Last Updated: | September 25, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by University of Colorado, Denver:
|
human milk infant growth obesity diabetes breastfeeding |
Additional relevant MeSH terms:
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Obesity Overweight Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Overnutrition Nutrition Disorders Signs and Symptoms Pregnancy Complications |
ClinicalTrials.gov processed this record on May 19, 2013