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Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial

NCT02308735 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 4

Last updated 2021-02-21

Study results available
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Summary

Gestational diabetes mellitus (GDM) affects as many as 14% of women in the United States. Furthermore, the number of pregnant women with pregestational diabetes mellitus (PGDM) is also increasing, mainly due to an increase in the diagnosis of non-insulin dependent diabetes mellitus. A recent study demonstrated that 1.3% of pregnancies are now complicated by PGDM and that PGDM now comprises 21% of the diabetes that complicate gestations, which represents a two fold increase since 1999. One notable side effect of diabetes is an elevation of endogenous ethanol production, which in turn may result in a rise in fetal production of fatty acid ethyl ester (FAEE). FAEE found in meconium have been utilized as a marker of prenatal ethanol exposure. Therefore, FAEE elevation could call into question maternal claims of abstinence from alcohol during pregnancy. This study seeks to determine if meconium FAEE levels in the newborns of abstinent women with various classifications of diabetes mellitus are increased when compared to non-diabetic, abstaining controls.

Conditions

  • Infants of Diabetic Mothers

Interventions

OTHER

N/A - No intervention

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Douglas C Dannaway, MD · Dept of Pediatrics

Eligibility

Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-09-01
Completion
2017-09-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02308735 on ClinicalTrials.gov