Alternate Biomarkers for Better Management of Diabetes During Pregnancy and Prediction of Neonatal Complications in Pregnant Women With Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus in Pregnancy
- Sponsor
- Washington University School of Medicine
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Glucose Control
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Glycated Albumin(up to 60 weeks from enrollment)
- Glycated Serum Protein (GSP)(up to 60 weeks from enrollment)
- Beta-hydroxybutyrate(up to 60 weeks from enrollment)
- Triglycerides(up to 60 weeks from enrollment)