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

NCT06048510 | Recruiting

• 1 other identifier: CHUBX 2022/26
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Macrosomia, Fetal; Gestational Diabetes Mellitus in Pregnancy

Keywords

skin autofluorescence; glycated albumin,; HbA1c; glycation biomarkers; macrosomia; gestational diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Fetal morbidity

  Between the day of delivery and the following day

• Obstetrical outcome

  Between the day of delivery and the following day

• Maternal morbidity

  Between the day of delivery and the following day

• Neonatal morbidity 1

  Between the day of delivery and the following day

• Neonatal morbidity 2

  Between the day of delivery and the following day

Study Arms (1)

Pregnant women

EXPERIMENTAL

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

Interventions

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.

Pregnant women

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Société Francophone du Diabète: collaborator

Study Sites (1)

Hopital Pellegrin

Bordeaux, 33000, France

RECRUITING

MeSH Terms

Conditions

Fetal Macrosomia; Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Central Study Contacts

FOUSSARD NINON, Dr

CONTACT

5.57.65.60.78; ninon.foussard@u-bordeaux.fr

RIGALLEAU VINCENT, Pr

CONTACT

5.57.65.60.78; vincent.rigalleau@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: September 21, 2023
• Study Start: December 18, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)