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

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus in Pregnancy; Macrosomia, Fetal
• Intervention / Treatment: Diagnostic test: Pregnant women

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FOUSSARD NINON, Dr; Phone Number: +33 5.57.65.60.78; Email: ninon.foussard@u-bordeaux.fr
• Study Contact Backup: Name: RIGALLEAU VINCENT, Pr; Phone Number: +33 5.57.65.60.78; Email: vincent.rigalleau@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • Recruiting
    • Hôpital Pellegrin
    • Contact: FOUSSARD NINON, Dr; Phone Number: +33 5.57.65.60.78; Email: ninon.foussard@u-bordeaux.fr
    • Contact: MILAN LEA; Phone Number: +33 5 57 82 07 38; Email: lea.milan@chu-bordeaux.fr
    • Principal Investigator: SENTILHES LOIC, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fetal morbidity	Incidence of fetal death in utero	Between the day of delivery and the following day
Obstetrical outcome	Incidence of labor induction, caesarean section, instrumental delivery.	Between the day of delivery and the following day
Maternal morbidity	Documentation of maternal morbidity diagnosis	Between the day of delivery and the following day
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
Neonatal morbidity 2	Documentation of neonatal morbidity diagnosis	Between the day of delivery and the following day
Neonatal morbidity 3	Hospitalization in neonatology or neonatal intensive care unit	Between the day of delivery and the following day
Neonatal morbidity 4	Presence of anoxic-ischemic encephalopath or neonatal seizure	Between the day of delivery and the following day

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Société Francophone du Diabète

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: HbA1c; gestational diabetes mellitus; macrosomia; skin autofluorescence; glycated albumin,; glycation biomarkers
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Body Weight; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Fetal Diseases; Diabetes Complications; Pregnancy in Diabetics; Birth Weight; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Diabetes, Gestational; Fetal Macrosomia
• Other Study ID Numbers: CHUBX 2022/26

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No