NCT06048510

New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Gestational diabetes mellitus (GDM) increases the risk of macrosomia and other adverse pregnancy outcomes. Screening strategies are debated: universal vs. selective, and macrosomia may begin before the time of screening, suggesting that glycation markers may have an interest. The objective of this trail is to compare novel markers: skin autofluorescence and glycated albumin, to HbA1c (reference) as predictors of GDM, macrosomia and other adverse outcomes, in pregnant women.

Conditions

• Macrosomia, Fetal
• Gestational Diabetes Mellitus in Pregnancy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pregnant women	Gestational Diabetes Mellitus increases the risk of adverse pregnancy outcomes (such as macrosomia). The lack of early clinical symptoms leads to screen pregnant women for GDM, and the strategies of screening are a matter of debate. Interventions to control glucose levels in women with GDM have demonstrated efficacy in terms of macrosomia. However, macrosomia may start before the time of screening, suggesting that markers of glycation may have interest : skin autofluorescence, glycated albumin.

Timeline

• Start date: 2023-12-18
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2023-09-21
• Last updated: 2026-01-15

Locations

1 site across 1 country: France