Biomarkers During Pregnancy

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gestational Diabetes; Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Other: Specimens Collected

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 Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in St Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 48 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Our study population includes a large percentage of African Americans as well as a significant percentage of women with BMI ≥30. All women enrolled in the study will be pregnant and have been diagnosed with diabetes.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With Diabetes; Pregnant women with diabetes - either diagnosed beforehand or diagnosed during gestation	Other: Specimens Collected; Serum will be collected from patients at multiple times during pregnancy for later analysis.
Controls; Biobank samples will be obtained from similar age/BMI/ethnicity women who do not have evidence of diabetes.	Other: Specimens Collected; Serum will be collected from patients at multiple times during pregnancy for later analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): November 1, 2021
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 201808125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No