Diabetes Mellitus in Pregnancy, Gestational Diabetes
Conditions
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.
Interventions
OTHERSpecimens Collected
Serum will be collected from patients at multiple times during pregnancy for later analysis.
Sponsors
Washington University School of Medicine
National Institutes of Health (NIH)
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 48 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Control | 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 | up to 60 weeks from enrollment | various adverse neonatal events will be reported and compared to other biomarkers measured by the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycated Albumin | up to 60 weeks from enrollment | Levels of % glycated albumin will be measured in the various cohorts to see if correlations exist with glucose control and adverse neonatal events |
| Glycated Serum Protein (GSP) | up to 60 weeks from enrollment | Levels of glycated serum protein will be measured in the various cohorts to see if correlations exist with glucose control and adverse neonatal events |
| Beta-hydroxybutyrate | up to 60 weeks from enrollment | Levels of beta-hydroxybutyrate will be measured in the various cohorts to see if correlations exist with glucose control and adverse neonatal events |
| Triglycerides | up to 60 weeks from enrollment | Levels of triglycerides will be measured in the various cohorts to see if correlations exist with glucose control and adverse neonatal events |
Countries
United States
Contacts
STUDY_CHAIREbony Carter, MD
Washington University School of Medicine
Outcome results
None listed