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

NCT ID: NCT01693406

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Type 2 Diabetes Gestational Diabetes

Keywords

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human milk infant growth obesity diabetes breastfeeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal Weight

Normal weight and normoglycemic women: Pre-pregnancy BMI between 18.5 - 24.9 kg/m2.

No interventions assigned to this group

Overweight/Obese

Overweight and normoglycemic women: Pre-pregnancy BMI between \> 25 kg/m2.

No interventions assigned to this group

Gestational Diabetes

Women who develop gestational diabetes and return to normal glucose control after delivery.

No interventions assigned to this group

Type 2 Diabetes

Women who are overweight and have Type 2 Diabetes that was diagnosed before pregnancy: Pre-pregnancy BMI \> 25 kg/m2.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Thrasher Research Fund

OTHER

Sponsor Role collaborator

American Diabetes Association

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy F Krebs, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Linda A Barbour, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37506974 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27140533 (View on PubMed)

Other Identifiers

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12-0629

Identifier Type: -

Identifier Source: org_study_id