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NCT01693406 · ClinicalTrials.gov registry record
Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers
A clinical trial, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- 59
- Enrollment target
NCT01693406: Completed study, sponsored by University of Colorado, Denver.
NCT01693406 is a clinical trial that has completed, run by University of Colorado, Denver. The registered enrollment target is 59 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01693406 has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- 59 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Body composition is measured by skin folds and air displacement plethysmography (PeaPod)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2012-08 |
| Est. Completion | 2020-09 |
What the finished NCT01693406 record still lists
NCT01693406 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 59 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01693406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01693406 about?
NCT01693406 is a clinical study titled "Breast Milk and Infant Growth Among Lean, Overweight and Diabetic Mothers". 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 ...
What is the current status of trial NCT01693406?
This trial is currently completed. The enrollment target is 59 participants. The study started on 2012-08. Estimated completion is 2020-09.
Who is sponsoring clinical trial NCT01693406?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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