Diabetes Mellitus in PregnancyNCT04108455
Biomarkers During Pregnancy
An observational study of Diabetes Mellitus in Pregnancy and Gestational Diabetes, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study aims to obtain preliminary data for utility of alternate biomarkers for monitoring glucose control in diabetic women during pregnancy and/or predicting risk of adverse neonatal events in these women. Read more about this study
- Who is it for?
- Ages 14 to 48 years, women only
- Conditions the study is for
- Diabetes Mellitus in Pregnancy, Gestational Diabetes
- What is being tested?
- Specimens Collected
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2019to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 to 48 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Our study population includes a large percentage of African Americans as well as a significant percentage of women with BMI ≥30. All women enrolled in the study will be pregnant and have been diagnosed with diabetes.
Who may be able to join
- All women included in the study will either have diabetes diagnosed before pregnancy or will have been diagnosed during pregnancy (GDM). We do not exclude minors, since in Missouri, they may consent to medical treatment without parental consent for medical issues relating to pregnancy,
Who cannot join
- No specific exclusion criteria will be used. BMI data will be collected and utilized to sort patients into various subgroups, but will not be used as exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St Louis
St Louis, Missouri, 63110
About this study
Official title: Alternate Biomarkers for Better Management of Diabetes During Pregnancy and Prediction of Neonatal Complications in Pregnant Women With Diabetes
This study aims to obtain preliminary data for utility of alternate biomarkers for monitoring glucose control in diabetic women during pregnancy and/or predicting risk of adverse neonatal events in these women.
Read the detailed description
This study aims to obtain preliminary data for utility of alternate biomarkers for monitoring glucose control in diabetic women during pregnancy and/or predicting risk of adverse neonatal events in these women. Our population is unique compared to published studies and contains significant numbers of African American women and overweight or obese women. Two of these markers have been examined in several other populations of pregnant women and have shown utility for both outcomes. However, the recommended levels of these markers need to be determined in specific populations as ethnicity and BMI affect the values. Values obtained in recruited women will be compared with biobank samples from women who have no evidence or history of diabetes. Additionally, two other potentially promising markers will be examined (beta-hydroxybutyrate and triglycerides). Both these analytes change during pregnancy and beta-hydroxybutyrate has shown correlation with large for gestational status or macrosomia in some studies. A combination of markers may be a better predictor of adverse neonatal outcomes than a single marker.
- Being tested
- Specimens Collected
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimens CollectedOther
Serum will be collected from patients at multiple times during pregnancy for later analysis.
| Study group | Role | What they receive |
|---|---|---|
| With Diabetes | Pregnant women with diabetes - either diagnosed beforehand or diagnosed during gestation Receives: Other: Specimens Collected | |
| Controls | Biobank samples will be obtained from similar age/BMI/ethnicity women who do not have evidence of diabetes. Receives: Other: Specimens Collected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Control
various measures of glucose control will be reported and compared to other biomarkers measured by the study
Measured: up to 60 weeks from enrollment
Adverse Neonatal Events
various adverse neonatal events will be reported and compared to other biomarkers measured by the study
Measured: up to 60 weeks from enrollment
Secondary outcomes (4)
Glycated Albumin
Levels of % glycated albumin will be measured in the various cohorts to see if correlations exist with glucose control and adverse neonatal events
Measured: up to 60 weeks from enrollment
Glycated Serum Protein (GSP)
Levels of glycated serum protein will be measured in the various cohorts to see if correlations exist with glucose control and adverse neonatal events
Measured: up to 60 weeks from enrollment
Beta-hydroxybutyrate
Levels of beta-hydroxybutyrate will be measured in the various cohorts to see if correlations exist with glucose control and adverse neonatal events
Measured: up to 60 weeks from enrollment
Triglycerides
Levels of triglycerides will be measured in the various cohorts to see if correlations exist with glucose control and adverse neonatal events
Measured: up to 60 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start15 Mar 2019
- Primary completion1 Nov 2021
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Ebony Carter, MD, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108455
- Sponsor's protocol ID
- 201808125
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2019
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Powers Carson J, Arora J, Carter E. Glycated Albumin to Predict Adverse Neonatal Outcomes among Women with Diabetes and Overweight or Obese Body Mass Index. J Appl Lab Med. 2024 Nov 4;9(6):938-948. doi: 10.1093/jalm/jfae079.
PubMed 39087706
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternate Biomarkers for Better Management of Diabetes During Pregnancy and Prediction of Neonatal Complications in Pregnant Women With Diabetes
- ClinicalTrials.gov ID
- NCT04108455
- Acronym / sponsor ID
- 201808125
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to obtain preliminary data for utility of alternate biomarkers for monitoring glucose control in diabetic women during pregnancy and/or predicting risk of adverse neonatal events in these women.
Detailed description
This study aims to obtain preliminary data for utility of alternate biomarkers for monitoring glucose control in diabetic women during pregnancy and/or predicting risk of adverse neonatal events in these women. Our population is unique compared to published studies and contains significant numbers of African American women and overweight or obese women. Two of these markers have been examined in several other populations of pregnant women and have shown utility for both outcomes. However, the recommended levels of these markers need to be determined in specific populations as ethnicity and BMI affect the values. Values obtained in recruited women will be compared with biobank samples from women who have no evidence or history of diabetes. Additionally, two other potentially promising markers will be examined (beta-hydroxybutyrate and triglycerides). Both these analytes change during pregnancy and beta-hydroxybutyrate has shown correlation with large for gestational status or macrosomia in some studies. A combination of markers may be a better predictor of adverse neonatal outcomes than a single marker.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Diabetes | – | Other: Specimens CollectedPregnant women with diabetes - either diagnosed beforehand or diagnosed during gestation |
| Controls | – | Other: Specimens CollectedBiobank samples will be obtained from similar age/BMI/ethnicity women who do not have evidence of diabetes. |
Who may qualify
- Ages
- 14 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Our study population includes a large percentage of African Americans as well as a significant percentage of women with BMI ≥30. All women enrolled in the study will be pregnant and have been diagnosed with diabetes.
Key inclusion criteria (1 listed)
- All women included in the study will either have diabetes diagnosed before pregnancy or will have been diagnosed during pregnancy (GDM). We do not exclude minors, since in Missouri, they may consent to medical treatment without parental consent for medical issues relating to pregnancy,
Key exclusion criteria (1 listed)
- No specific exclusion criteria will be used. BMI data will be collected and utilized to sort patients into various subgroups, but will not be used as exclusion criteria.
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 |
|---|---|---|
| Specimens CollectedSerum will be collected from patients at multiple times during pregnancy for later analysis. | Other | Controls, With Diabetes |
Primary outcome
Glucose Control
Time frame: up to 60 weeks from enrollment
various measures of glucose control will be reported and compared to other biomarkers measured by the study
Adverse Neonatal Events
Time frame: up to 60 weeks from enrollment
various adverse neonatal events will be reported and compared to other biomarkers measured by the study
4 secondary outcomes
Glycated Albumin
Time frame: up to 60 weeks from enrollment
Glycated Serum Protein (GSP)
Time frame: up to 60 weeks from enrollment
Beta-hydroxybutyrate
Time frame: up to 60 weeks from enrollment
Triglycerides
Time frame: up to 60 weeks from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Results publication: PubMed 39087706Powers Carson J, Arora J, Carter E. Glycated Albumin to Predict Adverse Neonatal Outcomes among Women with Diabetes and Overweight or Obese Body Mass Index. J Appl Lab Med. 2024 Nov 4;9(6):938-948. doi: 10.1093/jalm/jfae079.
- Individual participant dataSharing planned: No
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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.
Ebony Carter, MD study chair
Washington University School of Medicine
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 Diabetes Mellitus in Pregnancy and Gestational Diabetes, run by Washington University School of Medicine 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 18 Aug 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glucose Control (time frame: up to 60 weeks from enrollment). 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 NCT04108455, which also lists 1 linked publication.
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 18 Aug 2026.