Macrosomia, FetalGLYCAGESTNCT06048510
New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.
A study testing Pregnant women in people with Macrosomia, Fetal and Gestational Diabetes Mellitus in Pregnancy, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Macrosomia, Fetal, Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Pregnant women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2023to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Pellegrin
Bordeaux, 33000
FOUSSARD NINON, Dr, 5.57.65.60.78 ext. +33, ninon.foussard@u-bordeaux.fr
MILAN LEA, 5 57 82 07 38 ext. +33, lea.milan@chu-bordeaux.fr
About this study
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.
- Being tested
- Pregnant women
- Keywords
- skin autofluorescence, glycated albumin,, HbA1c, glycation biomarkers, macrosomia, gestational diabetes mellitus
- Medical subject headings
- Fetal Macrosomia, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant womenDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Diagnostic Test: Pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At trimester 1
Secondary outcomes (7)
Fetal morbidity
Incidence of fetal death in utero
Measured: Between the day of delivery and the following day
Obstetrical outcome
Incidence of labor induction, caesarean section, instrumental delivery.
Measured: Between the day of delivery and the following day
Maternal morbidity
Documentation of maternal morbidity diagnosis
Measured: 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)
Measured: Between the day of delivery and the following day
Neonatal morbidity 2
Documentation of neonatal morbidity diagnosis
Measured: Between the day of delivery and the following day
Neonatal morbidity 3
Hospitalization in neonatology or neonatal intensive care unit
Measured: Between the day of delivery and the following day
Neonatal morbidity 4
Presence of anoxic-ischemic encephalopath or neonatal seizure
Measured: Between the day of delivery and the following day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start18 Dec 2023
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macrosomia, FetalStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Société Francophone du Diabète
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048510
- Sponsor's protocol ID
- CHUBX 2022/26
- Acronym
- GLYCAGEST
- Status last verified
- Jan 2026
- First submitted
- 17 Jul 2023
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.
- ClinicalTrials.gov ID
- NCT06048510
- Acronym / sponsor ID
- GLYCAGEST / CHUBX 2022/26
- Keywords
- skin autofluorescence, glycated albumin,, HbA1c, glycation biomarkers, macrosomia, gestational diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Société Francophone du Diabète
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | Experimental | Diagnostic Test: Pregnant womenPregnant 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). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnant womenGestational 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. | Diagnostic test | Pregnant women |
Primary outcome
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).
7 secondary outcomes
Fetal morbidity
Time frame: Between the day of delivery and the following day
Obstetrical outcome
Time frame: Between the day of delivery and the following day
Maternal morbidity
Time frame: Between the day of delivery and the following day
Neonatal morbidity 1
Time frame: Between the day of delivery and the following day
Neonatal morbidity 2
Time frame: Between the day of delivery and the following day
Neonatal morbidity 3
Time frame: Between the day of delivery and the following day
Neonatal morbidity 4
Time frame: Between the day of delivery and the following day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregnant women in people with Macrosomia, Fetal and Gestational Diabetes Mellitus in Pregnancy, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FOUSSARD NINON, Dr (5.57.65.60.78 ext. +33, ninon.foussard@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of GDM diagnosed during pregnancy. (time frame: At trimester 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.