The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- University of Colorado, Denver
- Study ID
- NCT04394806
- Status
- Recruiting
Conditions
- Pregnancy
Eligibility Criteria
- Sex
- ALL
- Age
- 0 Years - 39 Years
- Healthy Volunteers
- Accepted
Study Details
This study plans to learn more about how triglyceride levels in pregnancy affect newborn fat mass. Obesity in pregnancy, in the absence of gestational diabetes, is now the most common cause of large-for-gestational-age infants and increased newborn fat mass. Previous data supports the idea that maternal triglycerides, not glucose, are the strongest predictor of both total newborn fat mass and liver fat. In this study, mothers will monitor triglyceride and glucose levels at specific points in pregnancy using point-of-care meters at home. Two weeks after birth, infants will have total fat measured by air-displacement plethysmography (PEAPOD) and liver fat measures by Magnetic Resonance Spectroscopy (MRS). The central hypothesis is that in obesity, fasting triglycerides and postprandial triglycerides will predict newborn fat mass in a free-living environment.
Key Dates
- Start date
- Mar 1, 2022
- Status verified
- May 2026
- Primary completion
- Jul 31, 2027
- Completion
- Jul 31, 2027
Study Design
- Enrollment
- 140 participants (estimated)
Primary Outcome Measure
Newborn Fat Mass [ Time Frame: 7-14 days after birth ]
Central Contacts
- Emily Z Dunn, MS, RDN303-724-0320
- Nicole Hirsch, MS303-724-0572
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado/Anschutz Medical Campus | Aurora | Colorado | 80045 | Linda A Barbour, MD, MSPH (SUB_INVESTIGATOR) Teri L Hernandez, PhD, RN (PRINCIPAL_INVESTIGATOR) |
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