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NCT Number: NCT04451915

Early Gestational Diabetes Mellitus

In 2010, the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) panel published consensus-based recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Cognizant that milder degrees of hyperglycemia would also be detected by early pregnancy testing, the IADPSG recommended that fasting plasma glucose (FPG) in the range of 5.1-6.9 mmol/l should be considered diagnostic of early Gestational Diabetes Mellitus (GDM) even if the level of proof for this recommendation is very low regarding to prognosis. This threshold was extrapolated from the FPG value used between 24 and 28 weeks.

In France, a FPG is proposed at the first prenatal visit for women with risk factors of GDM. Early GDM is diagnosed if FPG is ≥ 5.1 mmol/l, leading to an intensive metabolic management. Data have shown that GDM prevalence increased rapidly from 5.9% in 2009 to 9.3% in 2014. 26.9% of women with hyperglycemia during their pregnancy but without known diabetes are treated before 22 weeks' gestation (WG). More recent data from Italy and China, where IADPSG diagnosis criteria were applied, have strongly challenged this recommendation, and showed that early FPG ≥ 5.1mmo/L is poorly predictive of later GDM. No prior studies have demonstrated benefits to early screening and management. In 2016, the IADPSG members have suggested that the use of the FPG threshold ≥5.1 mmol/l for the identification of GDM in early pregnancy is not justified by current evidence

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Disease Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CH ARRAS, Arras, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant woman
  • Singleton pregnancy
  • Early GDM defined by a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/ with at least one risk factor (age ≥35 years and/or BMI ≥ 25 kg/m2 and/or familial history of diabetes and/or personal history of GDM and/or personal history of macrosomia).
  • First prenatal visit prior 20 weeks of gestation at the time of randomization.
  • Signed informed consent

Exclusion criteria

Diabetic follow-up started at time of inclusion

  • Pre-existing diabetes in pregnancy
  • Renal impairment
  • Hepatic insufficiency
  • History of bariatric surgery
  • Long time corticosteroids treatment
  • Insufficient understanding
  • Language difficulties
  • Lack of social Insurance
  • Person in emergency situation
  • Person under the protection of justice (tutelage/ curatorship)
  • Persons deprived of their liberty

Treatment and study plan

late management strategy

Other

late management strategy of GDM defined as no intervention until GDM screening at 24-28 weeks. Between 24-28 weeks gestation, a 75-g OGTT will be done

early management strategy

Other

early management of GDM defined as intensive metabolic treatment. Intensive treatment involved the following multidisciplinary approach: lifestyle defined by diet and exercise intervention according to the French guidelines

Primary outcomes

  1. The occurrence of materno-fetal complications

    Time frame: at delivery

    Composite endpoint defined by Large for Gestational Age (LGA) (defined by birth weight ≥90th percentile, adjusted for gestational age, sex, maternal BMI, parity, ethnicity) and/or neonatal hypoglycemia and/or shoulder dystocia and/or birth traumatisms

Secondary outcomes

  1. Correlation between composite endpoint (defined in the outcome 1) and the 5 risk factors of GDM

    Time frame: at delivery

    Correlation between composite endpoint (defined in the outcome 1) and the 5 risk factors of GDM (age more or equal to 35 years, BMI more or equal to 25 kg/m2, familial history of diabetes, personal history of GDM, personal history of macrosomia)

  2. Need for insulin during pregnancy

    Time frame: at each 10 days until delivery

    After at least 10 days of dietary and lifestyles measures, if the target are not achieved, women will receive insulin therapy. fastin glucose target <5.1 mmol/ and/or a 2 hour post prandial capillary glucose < 6.6 mmol/l

    at each 10 days a contact with the diabetologist or the nurses for the transmission of the capillary glycaemia either by phone or by the platform 'myDiabby"

  3. Metabolic data: Fasting plasma glucose

    Time frame: at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation

    Change of value of fasting plasma glucose

  4. Metabolic data: HbA1c

    Time frame: at inclusion (because <20 weeks') and an average at 24 28 weeks of gestation

    Change of value of HbA1c

  5. Oral Glucose Tolerance Test (OGTT)

    Time frame: an average at 24 28 weeks of gestation

  6. Percent of GDM women in the late GDM management group according to the IADPSG criteria.

    Time frame: an average at 24 28 weeks of gestation

    IADPSG criteria(fasting glucose more or equal to 5.1 mmol/l and/or 1h more or equal to 10.0 mmol/l and /or 2h more or equal to 8.5 mmol/l

  7. Number of complications in each subgroup of the late GDM management group

    Time frame: at delivery

    Maternal and neonatal complication

  8. Neonatal anthropometric parameters

    Time frame: 6 weeks after delivery

    Weight (kilograms), height in centimeters will be combined to report body mass index (kg/m2) at 6 weeks after delivery.

    GDM+ children, body mass index (BMI) z score, , waist circumference, Height was measured to the nearest 0.1 centimeter using a stadiometer, weight was measured to the nearest 0.1 kilogram using a calibrated balance (Tanita BC-418) and BMI was calculated (kg/m2). Children's BMI z-score was calculated using World Health Organization Anthroplus software (version 1.0.4, WHO, Geneva, Switzerland, 2009) and compared between birth and 6 weeks after delivery.

  9. Maternal plasma metabolic parameters

    Time frame: at 6 weeks after delivery

    Several biochemical parameters will be measured in maternal plasma both at inclusion and delivery such as (fasting) glucose (mM) using colorimetric detection kit, (fasting) plasma insulin (pM), and glycated hemoglobin (HbA1c) (%) using specific enzyme-linked immunosorbent assay (ELISA) kits. Glucose and insulin levels will be combined to report the HOMA-IR index, calculated as follows: Fasting insulin (pmol/L)/6.945) x fasting glucose (mmol/L))/22.5. Triglycerides (mM) and LDL- and HDL-cholesterol (mM) will be measured in maternal plasma between inclusion and delivery and determined simultaneously on Erba XL670 system. Exploratory analyses will be performed in maternal blood at inclusion and at delivery, using liquid-chromatography-high resolution combined with mass spectrometry in tandem in order to characterize the maternal metabolomic, lipidomic patterns as reflects of maternal metabolic status. Each variable will be expressed as %.

  10. Cord blood metabolic parameters

    Time frame: 6 weeks after delivery

    Glucose (mM) will be measured in cord blood using colorimetric detection kit, and insulin (pM), and glycated hemoglobin (HbA1c) (%) using specific enzyme-linked immunosorbent assay (ELISA) kits.

    Exploratory analyses will be performed in cord blood plasma, using liquid-chromatography-high resolution combined with mass spectrometry in tandem in order to characterize the umbilical cord blood metabolomic, lipidomic patterns as reflects of neonatal metabolic status in order to characterize the new-born metabolic status. Each variable will be expressed as %.

  11. Fecal microbiota composition and diversity in early and late GDM management group compared to euglycaemic group and, for the early and late GDM groups, analyzed according to GDM management of their own mothers and in regard of colostrum microbiota

    Time frame: at 6 weeks after delivery

    Fecal microbiota in infant feces collected will be analyzed following the French Gut workflow pipeline (https://hal.inrae.fr/hal-04707112v1) combining a large-scale longitudinal dataset of fecal microbiota limited to taxonomic composition of bacteria from 16S rRNA gene sequencing and high-throughput shotgun metagenomics with MetaGenoPolis facilities (https://mgps.eu/) that describe the microbiome at the functional level. A similar workflow will be used for analyze microbiota from colostrum.

    The shotgun sequencing data (expressed in % relative abundance and alpha-diversity using Shannon and Simpson indexes) together with the metadata provided (maternal GDM management, colostrum composition) using innovative statistical tools as path modelling approaches (tools specifically developed in the ANR GDM-MILK program a funder of this ancillary study GDM-MILK) will enable to evaluate both early and late GDM-management and colostrum microbiota impact on infant fecal microbiota.

  12. Breast milk composition (nutrients and bacterial community) in early and late GDM management group compared to euglycaemic group

    Time frame: at 6 weeks after delivery

Study contacts

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

Anne VAMBERGUE, MD,PhD

CONTACT

[email protected]

0320445962

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Late Versus Early Management of Gestational Diabetes Mellitus: a Non Inferiority Randomized Multicenter Trial

Acronym: LEMA_GDM

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2020
Registry last updated
Jun 2, 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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