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

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

— GLYCAGEST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06048510
• Other study ID #: CHUBX 2022/26
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: April 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Bordeaux
• Contact: FOUSSARD NINON, Dr
• Phone: 5.57.65.60.78
• Email: ninon.foussard[@]u-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion criteria:

1. Age = 18 years

2. Singleton pregnancy (or twin pregnancy reduced spontaneously or medically before 14 weeks of amenorrhea)

3. Gestational age at inclusion <28 weeks of amenorrhea

4. Participant affiliated with or beneficiary of a social security scheme

5. Collection of patient consent.

Exclusion criteria:

1. Gestational age at inclusion = 28 weeks of amenorrhea

2. Multiple pregnancy

3. Known diabetes prior to pregnancy

4. History of bariatric surgery

5. Expected delivery in another maternity unit not participating in the study

6. Person deprived of liberty by judicial or administrative decision

7. Guardianship or curatorship

8. Participant not affiliated or not benefiting from a social security scheme.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Fetal Macrosomia
• Gestational Diabetes Mellitus in Pregnancy
• Macrosomia, Fetal
• Pregnancy in Diabetics

Intervention

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.

Locations

Country	Name	City	State
France	Hopital Pellegrin	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Société Francophone du Diabète

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of GDM diagnosed during pregnancy.	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).	At trimester 1
Secondary	Fetal morbidity	Incidence of fetal death in utero	Between the day of delivery and the following day
Secondary	Obstetrical outcome	Incidence of labor induction, caesarean section, instrumental delivery.	Between the day of delivery and the following day
Secondary	Maternal morbidity	Documentation of maternal morbidity diagnosis	Between the day of delivery and the following day
Secondary	Neonatal morbidity 1	Incidence of macrosomia (by birth weight = 4,000g and Large for Gestational Age if = 90th centiles according to sex and gestational age)	Between the day of delivery and the following day
Secondary	Neonatal morbidity 2	Documentation of neonatal morbidity diagnosis	Between the day of delivery and the following day
Secondary	Neonatal morbidity 3	Hospitalization in neonatology or neonatal intensive care unit	Between the day of delivery and the following day
Secondary	Neonatal morbidity 4	Presence of anoxic-ischemic encephalopath or neonatal seizure	Between the day of delivery and the following day