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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06048510

Collaborator

Société Francophone du Diabète (Other)

800

Enrollment

Location

Arm

Anticipated Duration (Months)

49.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Macrosomia, Fetal Gestational Diabetes Mellitus in Pregnancy	Diagnostic Test: Pregnant women	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pregnant women Pregnant women, with gestational age at inclusion <28 weeks of amenorrhea, with or without risk factors for GDM will be included in the first consultation at the Maternity Hospital (Bordeaux University Hospital). Determination of glycation markers (HbA1c, glycated albumin, and skin autofluorescence).	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.

Arm

Intervention/Treatment

Experimental: Pregnant women

Pregnant women, with gestational age at inclusion <28 weeks of amenorrhea, with or without risk factors for GDM will be included in the first consultation at the Maternity Hospital (Bordeaux University Hospital). Determination of glycation markers (HbA1c, glycated albumin, and skin autofluorescence).

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.

Outcome Measures

Primary Outcome Measures

Incidence of GDM diagnosed during pregnancy. [At trimester 1]
The primary outcome is the incidence of GDM diagnosed during pregnancy after inclusion in the trial. The measure is performed by fasting blood glucose:≥ 0.92 g/L and < 1.26 g/L,or based on the result of the 75g OGTT performed at 24-28 weeks of amenorrhea, if glycemia at time 0 ≥ 92 mg/dL (5.06 mmol/L) and/or time 60min ≥ 180 mg/dL (9.9 mmol/L) and/or time 120min ≥153 mg/dL (8.42 mmol/L).

Secondary Outcome Measures

Fetal morbidity [Between the day of delivery and the following day]
Incidence of fetal death in utero
Obstetrical outcome [Between the day of delivery and the following day]
Incidence of labor induction, caesarean section, instrumental delivery.
Maternal morbidity [Between the day of delivery and the following day]
Documentation of maternal morbidity diagnosis
Neonatal morbidity 1 [Between the day of delivery and the following day]
Incidence of macrosomia (by birth weight ≥ 4,000g and Large for Gestational Age if ≥ 90th centiles according to sex and gestational age)
Neonatal morbidity 2 [Between the day of delivery and the following day]
Documentation of neonatal morbidity diagnosis
Neonatal morbidity 3 [Between the day of delivery and the following day]
Hospitalization in neonatology or neonatal intensive care unit
Neonatal morbidity 4 [Between the day of delivery and the following day]
Presence of anoxic-ischemic encephalopath or neonatal seizure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

Age ≥ 18 years
Singleton pregnancy (or twin pregnancy reduced spontaneously or medically before 14 weeks of amenorrhea)
Gestational age at inclusion <28 weeks of amenorrhea
Participant affiliated with or beneficiary of a social security scheme
Collection of patient consent.