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The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy
NCT04394806 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Study Locations (1)
Colorado
- University of Colorado/Anschutz Medical Campus — Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2022-03-01 |
| Est. Completion | 2027-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04394806
The ClinicalTrials.gov registry entry for NCT04394806 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,447 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pregnancy appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04394806 reports 1 study location spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04394806 about?
NCT04394806 is a clinical study titled "The Early and Late Contribution of Fasting and Postprandial Triglycerides on Newborn Subcutaneous and Intrahepatic Fat in Pregnancy". 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 mate...
What is the current status of trial NCT04394806?
This trial is currently recruiting. The enrollment target is 140 participants. The study started on 2022-03-01. Estimated completion is 2027-07.
What conditions does trial NCT04394806 study?
This clinical trial studies the following conditions: Pregnancy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT04394806?
This trial is sponsored by University of Colorado, Denver, which has 1,447 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04394806 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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