RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-01
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04394806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant women less than 16 weeks gestational age
  2. * Between the ages of 21-39 years
  3. * Pre-pregnancy BMI 28-39 kg/m2
  4. * Pre-gestational diabetes or prediabetes
  5. * History of gestational diabetes
  6. * History of pre-eclampsia, spontaneous pre-term delivery, or gestational hypertension \<34wks
  7. * Tobacco or illicit substance use
  8. * Chronic steroid use
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Emily Z Dunn, MS, RDN
CONTACT
303-724-0320
Emily.2.Dunn@cuanschutz.edu
Nicole Hirsch, MS
CONTACT
303-724-0572
Nicole.Hirsch@cuanschutz.edu

Principal Investigator

Linda A Barbour, MD, MSPH
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Teri L Hernandez, PhD, RN
PRINCIPAL_INVESTIGATOR
University of Colorado, Denver

Study Locations (Sites)

University of Colorado/Anschutz Medical Campus
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Linda A Barbour, MD, MSPH, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver
  • Teri L Hernandez, PhD, RN, PRINCIPAL_INVESTIGATOR, University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-01
Study Completion Date2027-07

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Triglycerides
  • Glucose
  • Adiposity
  • Air displacement plethysmography
  • Continuous glucose monitoring

Additional Relevant MeSH Terms

  • Pregnancy