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

NCT ID: NCT04394806

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-01

Study Completion Date

2027-07-31

Brief Summary

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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

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Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda A Barbour, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Teri L Hernandez, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado/Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emily Z Dunn, MS, RDN

Role: CONTACT

303-724-0320

Nicole Hirsch, MS

Role: CONTACT

303-724-0572

Facility Contacts

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Emily Dunn, MS, RDN

Role: primary

303-724-0320

References

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Barbour LA, Farabi SS, Friedman JE, Hirsch NM, Reece MS, Van Pelt RE, Hernandez TL. Postprandial Triglycerides Predict Newborn Fat More Strongly than Glucose in Women with Obesity in Early Pregnancy. Obesity (Silver Spring). 2018 Aug;26(8):1347-1356. doi: 10.1002/oby.22246. Epub 2018 Jun 22.

Reference Type BACKGROUND
PMID: 29931812 (View on PubMed)

Other Identifiers

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20-0706

Identifier Type: -

Identifier Source: org_study_id

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