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NCT03301753 · ClinicalTrials.gov registry record
Maternal Obesity, Breast Milk Composition, and Infant Growth
A clinical trial of Obesity and Pregnancy, sponsored by University of Minnesota.
- Active
- Registry status
- 2,050
- Enrollment target
- 2
- Study locations
NCT03301753: Active study of Obesity and Pregnancy, sponsored by University of Minnesota.
NCT03301753 is a study of Obesity and Pregnancy that is active but no longer recruiting, run by University of Minnesota. The registered enrollment target is 2,050 participants, above the 817-participant average among 1,053 other Obesity trials with a reported enrollment target (151% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03301753, a study of Obesity and Pregnancy, is active but no longer recruiting, sponsored by University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- 2,050 participants
- Enrollment target
- 2
- Study locations
Study Summary
Today the majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity, and neonatal insulin resistance. It was long thought that breast milk composition was fairly uniform among women, having been optimized through evolutionary time to provide adequate sole nutrition for the growing infant regardless of the environmental circumstances. However, recent evidence shows that breast milk is a highly complex fluid with significant inter-individual variation in hormonal and cytokine concentrations, human milk oligosaccharides (HMOs) and other features. Pervasive maternal obesity and gestational diabetes are evolutionarily novel conditions for the human species but little effort has yet been made to systematically examine how they are associated with breast milk adipose-tissue derived hormone and cytokine (adipocytokine) variation, HMOs, or other features, or whether that variation relates to infant metabolic status. The objective of this study is to comprehensively assess the "lactational programming" hypothesis, that is, whether or not recently documented variation in breast-milk composition is related to both maternal and infant metabolic status. The central hypothesis is that a graded, dose-response relationship between maternal adiposity and GDM exists with adipocytokine concentrations, HMOs, and other features in breast milk and that the milk concentrations of these features are associated with altered body composition in their exclusively breast-fed offspring. The results of the study will be used to design interventions to reduce maternal weight during pregnancy and lactation and to augment lactation education materials to focus on the needs of breastfeeding women with obesity and GDM.
Primary Outcome
Breastmilk hormone concentration changes
Conditions Studied
Study Locations (2)
Minnesota
- University of Minnesota School of Public Health - Minneapolis
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,050 participants |
| Start Date | 2014-07-01 |
| Est. Completion | 2026-12-31 |
What the registry record for NCT03301753 still lists
NCT03301753 is an observational study that tracks outcomes without assigning an intervention. Its 2,050 participants enrollment target places it among the larger protocols in the corpus, above the 817-participant average among 1,053 other Obesity trials with a reported enrollment target (151% higher).
The record links to 5 conditions, with Obesity appearing as the primary indexed condition, and to 0 interventions.
NCT03301753 reports a single indexed study location in Minnesota, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT03301753 about?
NCT03301753 is a clinical study titled "Maternal Obesity, Breast Milk Composition, and Infant Growth". Today the majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity, and neonatal insulin resistance. It was long thought that breast milk composition was fairly uniform ...
What is the current status of trial NCT03301753?
This trial is currently active not recruiting. The enrollment target is 2,050 participants. The study started on 2014-07-01. Estimated completion is 2026-12-31.
What conditions does trial NCT03301753 study?
This clinical trial studies the following conditions: Obesity, Pregnancy, Gestational Diabetes Mellitus (GDM), Breast Milk Collection, Infant Overnutrition.
Who is sponsoring clinical trial NCT03301753?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03301753 being conducted?
This trial has 2 study locations across Minnesota, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03301753's enrollment target sits among peer trials
2,050 42nd of 1053 higher than 1,011 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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