The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy

Recruiting

• Conditions: Pregnancy

• Registration Number: NCT04394806
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-19
• Study Start: 2022-03-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Pregnant women less than 16 weeks gestational age
• Between the ages of 21-39 years
• Pre-pregnancy BMI 28-39 kg/m2

Exclusion Criteria

• Pre-gestational diabetes or prediabetes
• History of gestational diabetes
• History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension <34wks
• Tobacco or illicit substance use
• Chronic steroid use

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Newborn Fat Mass	7-14 days after birth	Newborn fat mass measured by air displacement plethysmography (PeaPod)

Secondary Outcome Measures

Name	Time	Method
Newborn Intrahepatic Fat	7-14 days after birth	Newborn intrahepatic fat measured by Magnetic Resonance Spectroscopy (MRS)

Trial Locations

Locations (1)

University of Colorado/Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States