Clinical trial NCT04108455: Biomarkers During Pregnancy
Official title: Alternate Biomarkers for Better Management of Diabetes During Pregnancy and Prediction of Neonatal Complications in Pregnant Women With Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus in Pregnancy
Gestational Diabetes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-09-30
Enrollment: 47
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 48
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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,

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Glucose Control
timeFrame: up to 60 weeks from enrollment
measure: Adverse Neonatal Events
timeFrame: up to 60 weeks from enrollment
Secondary outcomes:
measure: Glycated Albumin
timeFrame: up to 60 weeks from enrollment
measure: Glycated Serum Protein (GSP)
timeFrame: up to 60 weeks from enrollment
measure: Beta-hydroxybutyrate
timeFrame: up to 60 weeks from enrollment
measure: Triglycerides
timeFrame: up to 60 weeks from enrollment
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ebony Carter, MD
role: STUDY_CHAIR
References: