Infants of Diabetic MothersFAEE-IDMNCT02308735
Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
An observational study of Infants of Diabetic Mothers, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Infants of Diabetic Mothers
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 1 Sep 2017
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
None listed.
Who cannot join
- . 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, 73104
About this study
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.
Read the detailed description
Researchers will approach four groups of pregnant women at 24-26 weeks when they present for routine obstetrical out-patient appointments:
- Those with PGDM
- Those with White's Class A1 GDM
- Those with White's Class A2 GDM
- 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.
- Conditions
- Infants of Diabetic Mothers
- Being tested
- N/A - No intervention
- Keywords
- gestation, diabetes, ethanol
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A - No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Pregnant women without either gestational or pre-gestational diabetes mellitus (and their offspring). Receives: Other: N/A - No intervention | |
| A1 IDM | Pregnant women with abnormal glucose tolerance test but normal fasting serum glucose levels (and their offspring). Receives: Other: N/A - No intervention | |
| A2 IDM | Pregnant women with abnormal glucose tolerance test and fasting hyperglycemia (and their offspring). Receives: Other: N/A - No intervention | |
| PGDM - IDM | Pregnant women with diabetes mellitus diagnosed prior to current pregnancy (and their offspring). Receives: Other: N/A - No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meconium Fatty Acid Ethyl Ester Concentration
A measure of ethanol metabolites in the meconium of an infant.
Measured: Three months
Phosphatidylethanol Level
A measure of phosphatidylethanol, an ethanol metabolite, in the cord blood of an infant.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startMar 2014
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Why it stopped: Technology has advanced beyond the applicability of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Infants of Diabetic MothersStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas C Dannaway, MD, Principal investigator, Dept of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308735
- Sponsor's protocol ID
- 3948
- Acronym
- FAEE-IDM
- Status last verified
- Feb 2021
- First submitted
- 2 Dec 2014
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 18779843Bell 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.
PubMed 18271881Lawrence 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.
PubMed 18223030Pichini 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.
PubMed 22168178Bearer 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.
PubMed 14571221Ostrea 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.
PubMed 16792562Otasevic 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.
PubMed 4669769Simic 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.
PubMed 21945304Peterson 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.
PubMed 18492517Gareri 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.
PubMed 18367988Zelner 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.
PubMed 22247425Bakhireva 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.
PubMed 24511895
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Acid Ethyl Esters in Meconium of Infants of Diabetic Mothers: a Pilot Trial
- ClinicalTrials.gov ID
- NCT02308735
- Acronym / sponsor ID
- FAEE-IDM / 3948
- Conditions
- Infants of Diabetic Mothers
- Keywords
- gestation, diabetes, ethanol
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Technology has advanced beyond the applicability of the study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Researchers will approach four groups of pregnant women at 24-26 weeks when they present for routine obstetrical out-patient appointments:
- Those with PGDM
- Those with White's Class A1 GDM
- Those with White's Class A2 GDM
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: N/A - No interventionPregnant women without either gestational or pre-gestational diabetes mellitus (and their offspring). |
| A1 IDM | – | Other: N/A - No interventionPregnant women with abnormal glucose tolerance test but normal fasting serum glucose levels (and their offspring). |
| A2 IDM | – | Other: N/A - No interventionPregnant women with abnormal glucose tolerance test and fasting hyperglycemia (and their offspring). |
| PGDM - IDM | – | Other: N/A - No interventionPregnant women with diabetes mellitus diagnosed prior to current pregnancy (and their offspring). |
Who may qualify
- Ages
- Up to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- . 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N/A - No intervention | Other | A1 IDM, A2 IDM, Control, PGDM - IDM |
Primary outcome
Meconium Fatty Acid Ethyl Ester Concentration
Time frame: Three months
A measure of ethanol metabolites in the meconium of an infant.
Phosphatidylethanol Level
Time frame: Three months
A measure of phosphatidylethanol, an ethanol metabolite, in the cord blood of an infant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18779843Bentley-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.
- Background: PubMed 18271881Bell 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.
- Background: PubMed 18223030Lawrence 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.
- Background: PubMed 22168178Pichini 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.
- Background: PubMed 14571221Bearer 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.
- Background: PubMed 16792562Ostrea 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.
- Background: PubMed 4669769Otasevic 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.
- Background: PubMed 21945304Simic 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.
- Background: PubMed 18492517Peterson 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.
- Background: PubMed 18367988Gareri 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.
- Background: PubMed 22247425Zelner 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.
- Background: PubMed 24511895Bakhireva 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas C Dannaway, MD principal investigator
Dept of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infants of Diabetic Mothers, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meconium Fatty Acid Ethyl Ester Concentration (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02308735, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.