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Clinical Trials/NCT04394806
NCT04394806
Recruiting
Not Applicable

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

University of Colorado, Denver1 site in 1 country140 target enrollmentMarch 1, 2022
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
University of Colorado, Denver
Enrollment
140
Locations
1
Primary Endpoint
Newborn Fat Mass
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
July 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Newborn Fat Mass

Time Frame: 7-14 days after birth

Newborn fat mass measured by air displacement plethysmography (PeaPod)

Secondary Outcomes

  • Newborn Intrahepatic Fat(7-14 days after birth)

Study Sites (1)

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