Biomarkers During Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Alternate Biomarkers for Better Management of Diabetes During Pregnancy and Prediction of Neonatal Complications in Pregnant Women With Diabetes

Conditions
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Diabetes Mellitus in Pregnancy, Gestational Diabetes

Intervention / Treatment
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* Other: Specimens Collected


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With Diabetes<br>Pregnant women with diabetes - either diagnosed beforehand or diagnosed during gestation | Other: Specimens Collected<br>* Serum will be collected from patients at multiple times during pregnancy for later analysis.<br>|
| Controls<br>Biobank samples will be obtained from similar age/BMI/ethnicity women who do not have evidence of diabetes. | Other: Specimens Collected<br>* Serum will be collected from patients at multiple times during pregnancy for later analysis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Control | various measures of glucose control will be reported and compared to other biomarkers measured by the study | 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 | up to 60 weeks from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | up to 60 weeks from enrollment |