New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia. - Clinical Trial for Macrosomia, Fetal | NCT06048510

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Pregnant women

About this trial

This is an interventional prevention trial for Macrosomia, Fetal focused on measuring skin autofluorescence, glycated albumin,, HbA1c, glycation biomarkers, macrosomia, gestational diabetes mellitus

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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. 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.

Sites / Locations

Hopital Pellegrin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pregnant women

Arm Description

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Fetal morbidity

Incidence of fetal death in utero

Obstetrical outcome

Incidence of labor induction, caesarean section, instrumental delivery.

Maternal morbidity

Documentation of maternal morbidity diagnosis

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)

Neonatal morbidity 2

Documentation of neonatal morbidity diagnosis

Neonatal morbidity 3

Hospitalization in neonatology or neonatal intensive care unit

Neonatal morbidity 4

Presence of anoxic-ischemic encephalopath or neonatal seizure

Full Information

NCT ID

NCT06048510

First Posted

July 17, 2023

Last Updated

October 17, 2023

Sponsor

University Hospital, Bordeaux

Collaborators

Société Francophone du Diabète

1. Study Identification

Unique Protocol Identification Number

NCT06048510

Brief Title

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

Acronym

GLYCAGEST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 2023 (Anticipated)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

Collaborators

Société Francophone du Diabète

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macrosomia, Fetal, Gestational Diabetes Mellitus in Pregnancy

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pregnant women

Arm Type

Experimental

Arm Description

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).

Intervention Type

Diagnostic Test

Intervention Name(s)

Pregnant women

Intervention Description

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 Outcome Measure Information:

Title

Incidence of GDM diagnosed during pregnancy.

Description

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).

Time Frame

At trimester 1

Secondary Outcome Measure Information:

Title

Fetal morbidity

Description

Incidence of fetal death in utero

Time Frame