Biomarkers During Pregnancy

The Washington University

Status: Active, not recruiting

Conditions: Gestational Diabetes; Diabetes Mellitus in Pregnancy

Treatments: Other: Specimens Collected

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04108455

201808125

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: Female

Ages: 14 to 48 years old

Volunteers: No Healthy Volunteers

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.

Trial design

47 participants in 2 patient groups

With Diabetes

Description:

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

Treatment:

Other: Specimens Collected

Controls

Description:

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

Treatment:

Other: Specimens Collected