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NCT Number: NCT06048510

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

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.

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Key information

Conditions

Macrosomia, Fetal Birth Weight Body Weight Congenital, Hereditary, and Neonatal Diseases and Abnormalities Diabetes Complications Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Macrosomia Gestational Diabetes Mellitus in Pregnancy Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy in Diabetics Signs and Symptoms Urogenital Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • Gestational age at inclusion ≥ 28 weeks of amenorrhea
  • Multiple pregnancy
  • Known diabetes prior to pregnancy
  • History of bariatric surgery
  • Expected delivery in another maternity unit not participating in the study
  • Person deprived of liberty by judicial or administrative decision
  • Guardianship or curatorship
  • Participant not affiliated or not benefiting from a social security scheme.

Treatment and study plan

Pregnant women

Diagnostic Test

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.

Primary outcomes

  1. Incidence of GDM diagnosed during pregnancy.

    Time frame: 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 outcomes

  1. Fetal morbidity

    Time frame: Between the day of delivery and the following day

    Incidence of fetal death in utero

  2. Obstetrical outcome

    Time frame: Between the day of delivery and the following day

    Incidence of labor induction, caesarean section, instrumental delivery.

  3. Maternal morbidity

    Time frame: Between the day of delivery and the following day

    Documentation of maternal morbidity diagnosis

  4. Neonatal morbidity 1

    Time frame: 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)

  5. Neonatal morbidity 2

    Time frame: Between the day of delivery and the following day

    Documentation of neonatal morbidity diagnosis

  6. Neonatal morbidity 3

    Time frame: Between the day of delivery and the following day

    Hospitalization in neonatology or neonatal intensive care unit

  7. Neonatal morbidity 4

    Time frame: Between the day of delivery and the following day

    Presence of anoxic-ischemic encephalopath or neonatal seizure

Study contacts

Contact information is provided by the study sponsor or research team.

FOUSSARD NINON, Dr

CONTACT

[email protected]

5.57.65.60.78 ext. +33

RIGALLEAU VINCENT, Pr

CONTACT

[email protected]

5.57.65.60.78 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Société Francophone du Diabète

Registry information

Acronym: GLYCAGEST

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2023
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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