Biomarkers During Pregnancy

NCT04108455 | Unknown DMC FDA Device

• 1 other identifier: 201808125
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus in Pregnancy; Gestational Diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (2)

With Diabetes

Pregnant women with diabetes - either diagnosed beforehand or diagnosed during gestation

Other: Specimens Collected

Controls

Biobank samples will be obtained from similar age/BMI/ethnicity women who do not have evidence of diabetes.

Other: Specimens Collected

Interventions

Specimens Collected OTHER

Serum will be collected from patients at multiple times during pregnancy for later analysis.

Controls; With Diabetes

Eligibility Criteria

• Age: 14 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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,

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Washington University in St Louis

St Louis, Missouri, 63110, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and plasma

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ebony Carter, MD

  Washington University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 30, 2019
• Study Start: March 15, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 30, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)