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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado/Anschutz Medical CampusAuroraColorado80045
Emily Dunn, MS, RDN
303-724-0320
Linda A Barbour, MD, MSPH (SUB_INVESTIGATOR)
Teri L Hernandez, PhD, RN (PRINCIPAL_INVESTIGATOR)

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