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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Diabetes | Pregnant women with diabetes - either diagnosed beforehand or diagnosed during gestation |
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| Controls | Biobank samples will be obtained from similar age/BMI/ethnicity women who do not have evidence of diabetes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specimens Collected | Other | Serum will be collected from patients at multiple times during pregnancy for later analysis. |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ebony Carter, MD | Washington University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St Louis | St Louis | Missouri | 63110 | United States |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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serum and plasma
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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |