Metabolism, Breastmilk, and Microbiome
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|ClinicalTrials.gov Identifier: NCT03522597|
Recruitment Status : Active, not recruiting
First Posted : May 11, 2018
Last Update Posted : March 7, 2023
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|Condition or disease|
|Obesity Diabetes, Gestational|
The incidence of both obesity and diabetes are on a staggering rise. Many studies suggest that by 2030, 40-50% of the population will be obese. The prevalence of gestational diabetes (GDM) is also increasing, and was recently reported to be 9%. GDM increases risk of obesity and impaired glucose tolerance in their children, but the mechanisms by which this occurs are not well defined.
The benefits of breastfeeding are numerous, including protection from sudden infant death and infection, positive cognitive outcomes, reduced prematurity complications, and decreased risk of cancer, as well as some evidence of protection against child obesity. One area that has yet to be thoroughly explored is whether there are differences in breast milk composition in women with diabetes as compared to non-diabetic women after adjusting for obesity and other diabetes co-morbidities, and how these differences could affect infant metabolic health and body composition. Experimental studies argue strongly for a causal relationship of the gut microbiome to the risk of obesity and diabetes. Breast milk strongly shapes the gut microbiome, as it contains unique oligosaccharides as well as hormones and immunologic factors that cultivate the growth of specific microbiota in the infant gut. Indeed over 90% of early infant fecal bacteria are Bifidobacteria, where in most formula-fed infants Bifidobacteria are non-detectable, which has been linked to the rapid growth and greater adiposity in formula-fed versus breastmilk-fed infants. Given that most pregnant women in the United States are now either overweight, obese, or diabetic, our study has high public health significance in that it seeks to understand how maternal metabolic factors such as these hinder the development of a healthy gut microbiome during the critical period of infancy.
In this study, the following study questions will be examined:1) does maternal metabolic state relate to the milk microbiome (bacterial and fungal diversity and abundance relationships, and microbiome function) and how they are transmitted to the infant gut? 2) does maternal metabolic state relate to the concentration of appetite and growth-regulating hormones and cytokines present in breast milk?; 3) are maternal serum concentrations of hormones and milk microbiomes associated with each other?; and 4) are milk hormones and/or milk microbiomes related to infant growth and body composition in the first 6 months of life?
Amplicon-based and deep (shotgun) metagenomic sequencing will be utilized to characterize species and strain level characteristics of maternal milk and infant fecal microbiomes. ELISA assays will be used to quantify adipose-tissue derived hormones (leptin, adiponectin) and immune factors (CRP, IL-6, TNF-α) as well as insulin/growth axis hormones (insulin, IGF-1, IGFBP-3) in breast milk. Infant body composition will be assessed using air displacement plethysmography and dual energy x-ray absorptiometry.
The above work will involve new recruitment enrollment, and pregnancy data collection from 50 diabetic mothers recruited through the Maternal Fetal Medicine and Women's Health Specialists at M Health. The pregnant non-diabetic (normal weight and obese) woman cohorts (and their infants and samples) for this study already exist as part of Clinical Trial NCT03301753 (Maternal Obesity, Breast Milk Composition, and Infant Growth (MILK) study), which is currently in the sample collection phase. The current study will form the first comprehensive comparison of multiple aspects of breastmilk composition in women with pregnancy diabetes as compared to non-diabetic women.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Maternal Metabolism, Breast Milk Composition, and Infant Outcomes: The 4M Project|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||July 1, 2023|
Normal weight (BMI) women and their infants
Obese (BMI) women and their infants
Women with gestational diabetes and their infants
- Breastmilk and infant microbiomes [ Time Frame: 1, 3, and 6 months postpartum ]Change in the diversity and abundance of breast milk and infant gut bacterial and fungal species and strains, and functional microbiome profiles
- Hormones in breastmilk [ Time Frame: 1 and 3 months postpartum ]Change in breastmilk concentrations of appetite and growth regulating hormones (leptin, insulin, adiponectin) and proteins (IGF-1, IGFBP3, CRP, IL-6) from milk.
- Hormones and cytokines in maternal serum [ Time Frame: At time of delivery (time 0) ]Maternal serum concentrations of appetite and growth regulating hormones (leptin, insulin, adiponectin) and proteins (IGF-1, IGFBP3, CRP, IL-6), and cytokines.
- Hormones and cytokines in infant serum [ Time Frame: At time of delivery (time 0) and 6 months postpartum ]Change in the concentrations of appetite and growth regulating hormones (leptin, insulin, adiponectin) and proteins (IGF-1, IGFBP3, CRP, IL-6), and cytokines from birth to age 6 months.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
(For new enrollment of 50 pregnant women with gestational diabetes and their infants. Enrollment of normal weight and obese cohort comparators already accomplished under ClinicalTrial NCT03301753):
- Pregnant women
- age 21-45 at time of delivery
- report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior), and if parity >1, that they successfully breastfed after a previous pregnancy for at least 3 months
- singleton pregnancy
- known gestational diabetes Definition of Gestational Diabetes: 1) an elevated glucose challenge test >200 mg/dL or 2) two abnormal values on the glucose tolerance test according to Carpenter-Coustan criteria.
- alcohol consumption >1 drink per week during pregnancy/lactation
- tobacco consumption during pregnancy/lactation,
- inability to speak/understand English
- known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding
- planned delivery at a site other than the University of Minnesota Medical Center- West Bank campus.
- preexisting diabetes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522597
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55454|
|Principal Investigator:||Cheryl A Gale, M.D.||University of Minnesota|
|Principal Investigator:||Ellen W Demerath, Ph.D.||University of Minnesota|
|Responsible Party:||University of Minnesota|
|Other Study ID Numbers:||
R01HD080444 ( U.S. NIH Grant/Contract )
|First Posted:||May 11, 2018 Key Record Dates|
|Last Update Posted:||March 7, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Female Urogenital Diseases and Pregnancy Complications
Glucose Metabolism Disorders
Endocrine System Diseases