Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers (MIG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Colorado, Denver
Sponsor:
Collaborators:
Thrasher Research Fund
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01693406
First received: September 21, 2012
Last updated: September 25, 2012
Last verified: September 2012
  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
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

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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
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

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693406

Contacts
Contact: Bridget E Young, PhD (303)724-3309 Bridget.Young@UCDenver.edu

Locations
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         
Sponsors and Collaborators
University of Colorado, Denver
Thrasher Research Fund
Investigators
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pregnancy Complications

ClinicalTrials.gov processed this record on July 20, 2014