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

NCT02308735 | Terminated Results

• 1 other identifier: 3948
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Infants of Diabetic Mothers

Keywords

gestation; diabetes; ethanol

Outcome Measures

Primary Outcomes (2)

• Meconium Fatty Acid Ethyl Ester Concentration

  A measure of ethanol metabolites in the meconium of an infant.

  Three months

• Phosphatidylethanol Level

  A measure of phosphatidylethanol, an ethanol metabolite, in the cord blood of an infant.

  Three months

Study Arms (4)

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

Interventions

N/A - No intervention OTHER

A1 IDM; A2 IDM; Control; PGDM - IDM

Eligibility Criteria

• Age: Up to 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Mothers who self-reported any alcohol or any illicit drug use during their pregnancy (and their babies)
• Mothers who had a positive drug screen at any point during their pregnancy (and their babies)
• Babies whose mothers suffered a placental abruption during their pregnancy.
• Babies whose mothers had inadequate prenatal care (defined as \<3 prenatal clinic visits prior to admission for delivery)
• Non-English-speaking mothers
• Babies who pass meconium in utero.
• Babies born with multiple congenital anomalies or abdominal wall defects.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Children's Hospital of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (12)

• Bentley-Lewis R, Levkoff S, Stuebe A, Seely EW. Gestational diabetes mellitus: postpartum opportunities for the diagnosis and prevention of type 2 diabetes mellitus. Nat Clin Pract Endocrinol Metab. 2008 Oct;4(10):552-8. doi: 10.1038/ncpendmet0965. Epub 2008 Sep 9.

  PMID: 18779843 BACKGROUND

• Bell R, Bailey K, Cresswell T, Hawthorne G, Critchley J, Lewis-Barned N; Northern Diabetic Pregnancy Survey Steering Group. Trends in prevalence and outcomes of pregnancy in women with pre-existing type I and type II diabetes. BJOG. 2008 Mar;115(4):445-52. doi: 10.1111/j.1471-0528.2007.01644.x.

  PMID: 18271881 BACKGROUND

• Lawrence JM, Contreras R, Chen W, Sacks DA. Trends in the prevalence of preexisting diabetes and gestational diabetes mellitus among a racially/ethnically diverse population of pregnant women, 1999-2005. Diabetes Care. 2008 May;31(5):899-904. doi: 10.2337/dc07-2345. Epub 2008 Jan 25.

  PMID: 18223030 BACKGROUND

• Pichini S, Marchei E, Vagnarelli F, Tarani L, Raimondi F, Maffucci R, Sacher B, Bisceglia M, Rapisardi G, Elicio MR, Biban P, Zuccaro P, Pacifici R, Pierantozzi A, Morini L. Assessment of prenatal exposure to ethanol by meconium analysis: results of an Italian multicenter study. Alcohol Clin Exp Res. 2012 Mar;36(3):417-24. doi: 10.1111/j.1530-0277.2011.01647.x. Epub 2011 Dec 14.

  PMID: 22168178 BACKGROUND

• Bearer CF, Jacobson JL, Jacobson SW, Barr D, Croxford J, Molteno CD, Viljoen DL, Marais AS, Chiodo LM, Cwik AS. Validation of a new biomarker of fetal exposure to alcohol. J Pediatr. 2003 Oct;143(4):463-9. doi: 10.1067/S0022-3476(03)00442-6.

  PMID: 14571221 BACKGROUND

• Ostrea EM Jr, Hernandez JD, Bielawski DM, Kan JM, Leonardo GM, Abela MB, Church MW, Hannigan JH, Janisse JJ, Ager JW, Sokol RJ. Fatty acid ethyl esters in meconium: are they biomarkers of fetal alcohol exposure and effect? Alcohol Clin Exp Res. 2006 Jul;30(7):1152-9. doi: 10.1111/j.1530-0277.2006.00131.x.

  PMID: 16792562 BACKGROUND

• Otasevic V, Lazovic V, Spalevic M, Marinkovic O. [Endogenous alcohol in patients with diabetes and in patients with severe liver disease]. Med Glas. 1972 Nov;26(11):391-4. No abstract available. Serbian.

  PMID: 4669769 BACKGROUND

• Simic M, Ajdukovic N, Veselinovic I, Mitrovic M, Djurendic-Brenesel M. Endogenous ethanol production in patients with diabetes mellitus as a medicolegal problem. Forensic Sci Int. 2012 Mar 10;216(1-3):97-100. doi: 10.1016/j.forsciint.2011.09.003. Epub 2011 Sep 25.

  PMID: 21945304 BACKGROUND

• Peterson J, Kirchner HL, Xue W, Minnes S, Singer LT, Bearer CF. Fatty acid ethyl esters in meconium are associated with poorer neurodevelopmental outcomes to two years of age. J Pediatr. 2008 Jun;152(6):788-92. doi: 10.1016/j.jpeds.2007.11.009. Epub 2008 Jan 10.

  PMID: 18492517 BACKGROUND

• Gareri J, Lynn H, Handley M, Rao C, Koren G. Prevalence of fetal ethanol exposure in a regional population-based sample by meconium analysis of fatty acid ethyl esters. Ther Drug Monit. 2008 Apr;30(2):239-45. doi: 10.1097/FTD.0b013e318167cfe5.

  PMID: 18367988 BACKGROUND

• Zelner I, Shor S, Lynn H, Roukema H, Lum L, Eisinga K, Koren G. Clinical use of meconium fatty acid ethyl esters for identifying children at risk for alcohol-related disabilities: the first reported case. J Popul Ther Clin Pharmacol. 2012;19(1):e26-31. Epub 2012 Jan 10.

  PMID: 22247425 BACKGROUND

• Bakhireva LN, Leeman L, Savich RD, Cano S, Gutierrez H, Savage DD, Rayburn WF. The validity of phosphatidylethanol in dried blood spots of newborns for the identification of prenatal alcohol exposure. Alcohol Clin Exp Res. 2014 Apr;38(4):1078-85. doi: 10.1111/acer.12349. Epub 2014 Feb 11.

  PMID: 24511895 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Urine sample, meconium sample, placental cord blood sample

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Douglas Dannaway
• Organization: University of Oklahoma Health Sciences Center

douglas-dannaway@ouhsc.edu

405-271-5215

Study Officials

• Douglas C Dannaway, MD

  Dept of Pediatrics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Locations

US (1)