Washington University in St Louis
St Louis, Missouri, 63110, United States
NCT Number: NCT04108455
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.
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Notify Me14 year–48 year
Female
Observational
St Louis, Missouri, 63110, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Serum will be collected from patients at multiple times during pregnancy for later analysis.
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
Time frame: up to 60 weeks from enrollment
various adverse neonatal events will be reported and compared to other biomarkers measured by the study
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Washington University School of Medicine
Other
Alternate Biomarkers for Better Management of Diabetes During Pregnancy and Prediction of Neonatal Complications in Pregnant Women With Diabetes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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