Biomarkers During Pregnancy

Active, not recruiting

• Conditions: Diabetes Mellitus in Pregnancy; Gestational Diabetes

• Registration Number: NCT04108455
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study Start: 2019-03-15
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-30
• Primary Completion: 2021-11-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-06
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 47

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Washington University in St Louis; 🇺🇸 Saint Louis, Missouri, United States