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Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial (FAEE-IDM)

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ClinicalTrials.gov Identifier: NCT02308735
Recruitment Status : Unknown
Verified November 2016 by University of Oklahoma.
Recruitment status was:  Recruiting
First Posted : December 4, 2014
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Infants of Diabetic Mothers Other: N/A - No intervention

Detailed Description:

Researchers will approach four groups of pregnant women at 24-26 weeks when they present for routine obstetrical out-patient appointments:

  1. Those with PGDM
  2. Those with White's Class A1 GDM
  3. Those with White's Class A2 GDM
  4. Non-diabetic controls

The medical records of these women will be examined to determine self-reporting of any alcohol or other drug usage while pregnant; women who report any illicit drug use (or ethanol use) while pregnant will not be eligible for this study. A routine urine drug screen will further confirm this finding. Women who have not reported alcohol use during their pregnancy will be questioned regarding medication usage while pregnant, as some medications do contain small amounts of ethanol. Women who are judged to have not consumed alcohol during their pregnancies (intentionally or incidentally) would then be included in the study.

Demographic information about the mother would also be collected (age, parity, length of pregnancy), as would the mother's most recent glycosylated hemoglobin level; additionally, a glycosylated hemoglobin level will be drawn on our presumptive controls (to allow for covert gestational diabetes mellitus). This lab draw would be added to the mother's routine lab studies and would not require an additional venipuncture.

A second urine drug screen will be performed on the mother upon her admission to the University of Oklahoma Health Sciences Center for the delivery of her baby. If both screens are negative and the baby does not meet any of the exclusion criteria, the baby will be enrolled in the study.

The initial meconium from each baby of the recruited mothers will be gathered. Approximately 1 g of meconium will be collected, frozen, and evaluated for fatty acid ethyl ester analysis at the United States Drug Testing Laboratories, Inc. We will also be sending a dried blood spot from the baby which will be collected at the time of the baby's scheduled newborn screen. This dried blood spot will be evaluated for phosphatidylethanol, an ethanol by-product.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
Study Start Date : March 2014
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017
Groups and Cohorts
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Group/Cohort Intervention/treatment
Control
Pregnant women without either gestational or pre-gestational diabetes mellitus (and their offspring).
 Other: N/A - No intervention
A1 IDM
Pregnant women with abnormal glucose tolerance test but normal fasting serum glucose levels (and their offspring).
 Other: N/A - No intervention
A2 IDM
Pregnant women with abnormal glucose tolerance test and fasting hyperglycemia (and their offspring).
 Other: N/A - No intervention
PGDM - IDM
Pregnant women with diabetes mellitus diagnosed prior to current pregnancy (and their offspring).
 Other: N/A - No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Meconium Fatty Acid Ethyl Ester Concentration [ Time Frame: Three months ]
    A measure of ethanol metabolites in the meconium of an infant.

  2. Phosphatidylethanol Level [ Time Frame: Three months ]
    A measure of phosphatidylethanol, an ethanol metabolite, in the cord blood of an infant.


Biospecimen Retention:   Samples With DNA
Urine sample, meconium sample, placental cord blood sample

Eligibility Criteria
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Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Teetotaling pregnant women either without a diagnosis of diabetes (controls) or with a diagnosis of diabetes mellitus (either gestational or pregestational).
  2. The liveborn infants resulting from the concurrent pregnancies of the women listed above.
Criteria

Inclusion Criteria: (understood to include only abstemious women)

  1. . Pregnant women expected to deliver between 37 and 41 weeks gestation (controls), and their babies
  2. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A1 diabetes mellitus, and their babies
  3. . Pregnant women expected to deliver between 37 and 41 weeks gestation who have class A2 diabetes mellitus, and their babies
  4. . Pregnant women expected to deliver between 37 and 41 weeks gestation who were diagnosed with diabetes mellitus prior to their pregnancy, and their babies.

Exclusion Criteria:

  1. . Mothers who self-reported any alcohol or any illicit drug use during their pregnancy (and their babies)
  2. . Mothers who had a positive drug screen at any point during their pregnancy (and their babies)
  3. . Babies whose mothers suffered a placental abruption during their pregnancy.
  4. . Babies whose mothers had inadequate prenatal care (defined as <3 prenatal clinic visits prior to admission for delivery)
  5. . Non-English-speaking mothers
  6. . Babies who pass meconium in utero.
  7. . Babies born with multiple congenital anomalies or abdominal wall defects.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308735


Contacts
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Contact: Douglas C Dannaway, MD 4052715215 ext 42048 douglas-dannaway@ouhsc.edu

Locations
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United States, Oklahoma
Children's Hospital of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Principal Investigator: Douglas C Dannaway, MD         
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Douglas C Dannaway, MD Dept of Pediatrics
More Information
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Additional Information:

Publications:

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT02308735    
Other Study ID Numbers: 3948
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Keywords provided by University of Oklahoma:
gestation
diabetes
ethanol
Additional relevant MeSH terms:
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Fetal Diseases
Pregnancy in Diabetics
Pregnancy Complications