Biomarkers During Pregnancy

Gestational Diabetes Clinical Trial

Official title:

Alternate Biomarkers for Better Management of Diabetes During Pregnancy and Prediction of Neonatal Complications in Pregnant Women With Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04108455
• Other study ID #: 201808125
• Status: Active, not recruiting
• Start date: March 15, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 47
• Est. completion date: November 30, 2023
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 48 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus in Pregnancy
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy in Diabetics

Intervention

Other:
• Specimens Collected
Serum will be collected from patients at multiple times during pregnancy for later analysis.

Locations

Country	Name	City	State
United States	Washington University in St Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Glycated Serum Protein (GSP)	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
Secondary	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
Secondary	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