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Protective Effect of Lactation Against Gestational Diabetes Mellitus in Subsequent Pregnancies: A Prospective Observational Cohort Study (LACGDM)

29. mai 2026 oppdatert av: Burak Deniz Aydoğdu, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Protective Effect of Lactation Against Gestational Diabetes Mellitus in Subsequent Pregnancy: A Prospective Observational Cohort Study

Gestational diabetes mellitus (GDM) is a common metabolic disorder of pregnancy associated with increased maternal and fetal morbidity. Lactation has been suggested to improve maternal glucose metabolism, enhance insulin sensitivity, and reduce the risk of future glucose intolerance. However, evidence regarding the protective effect of lactation on the development of GDM in subsequent pregnancies remains limited.

This prospective observational cohort study aims to evaluate the association between lactation and the risk of gestational diabetes mellitus and related pregnancy complications in women who conceive during the lactation period. Routine glycemic markers including fasting plasma glucose, HbA1c, glycosuria, and 75-g oral glucose tolerance test (OGTT) results will be recorded. Ultrasonographic findings including fetal abdominal circumference percentile, estimated fetal weight percentile, and amniotic fluid index will also be assessed. The study will investigate whether lactation is associated with a reduced risk of GDM, fetal macrosomia, and polyhydramnios in subsequent pregnancies.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

Gestational diabetes mellitus (GDM) is one of the most common metabolic complications of pregnancy and is associated with adverse maternal and neonatal outcomes, including fetal macrosomia, polyhydramnios, cesarean delivery, and future development of type 2 diabetes mellitus. Early identification of women at increased risk of GDM is essential for optimizing antenatal care and improving pregnancy outcomes.

Lactation has been reported to exert beneficial metabolic effects through increased glucose utilization, improved insulin sensitivity, and facilitation of postpartum weight loss. Previous studies have suggested that breastfeeding may reduce the long-term risk of type 2 diabetes in women with a history of GDM. However, evidence regarding the protective effect of lactation on the occurrence of gestational diabetes mellitus in subsequent pregnancies remains limited.

The present prospective observational cohort study aims to evaluate the relationship between lactation and the development of gestational diabetes mellitus in women who become pregnant during the lactation period. Pregnant women aged 18-50 years with singleton pregnancies who attend the participating obstetrics and gynecology clinics will be enrolled. Routine laboratory parameters obtained during antenatal care, including fasting plasma glucose, HbA1c, glycosuria, and 75-g oral glucose tolerance test (OGTT) results, will be recorded.

In addition, routine ultrasonographic measurements, including fetal abdominal circumference percentile (AC), estimated fetal weight percentile (EFW), and amniotic fluid index (AFI), will be collected during the second and third trimesters. Maternal demographic and obstetric characteristics, including age, gravidity, parity, abortion history, and educational status, will also be documented.

The primary objective of the study is to determine whether lactation is associated with a reduced risk of gestational diabetes mellitus. Secondary objectives include evaluating the association between lactation and pregnancy complications related to altered glucose metabolism, including fetal macrosomia and polyhydramnios. The findings of this study may contribute to a better understanding of the metabolic effects of lactation and provide evidence for strategies aimed at reducing the burden of gestational diabetes mellitus in future pregnancy.

Studietype

Observasjonsmessig

Registrering (Antatt)

140

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
      • Istanbul, Tyrkia (Türkiye), 34384
        • Rekruttering
        • Prof. Dr. Cemil Taşcıoğlu City Hospital
        • Ta kontakt med:
      • Istanbul, Tyrkia (Türkiye), 34517
        • Rekruttering
        • Esenyurt Necmi Kadıoğlu State Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Pregnant individuals aged 18-50 years who conceived during the lactation period and are receiving antenatal care at participating obstetrics and gynecology clinics. Participants must have singleton pregnancies and available routine glycemic and ultrasonographic follow-up data. The study population represents women undergoing standard prenatal care in a tertiary care and secondary care hospital setting.

Beskrivelse

Inclusion Criteria:

  • Pregnant individuals aged 18 to 50 years.
  • Singleton pregnancy.
  • Conception during the lactation period.
  • Follow-up at Prof. Dr. Cemil Taşcıoğlu City Hospital or Esenyurt Necmi Kadıoğlu State Hospital.
  • Availability of glycemic parameters including fasting plasma glucose, HbA1c, glycosuria, and 75-g oral glucose tolerance test (OGTT) results.
  • Availability of routine ultrasonographic measurements including fetal abdominal circumference percentile (AC), estimated fetal weight percentile (EFW), and amniotic fluid index (AFI).

Exclusion Criteria:

  • Age below 18 years.
  • Age above 50 years.
  • Multiple pregnancy.
  • Known chronic systemic disease or pre-existing diabetes mellitus.
  • Missing clinical, laboratory, or ultrasonographic data.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Pregnant Women During Lactation Period
Singleton pregnant women aged 18-50 years who conceived during the lactation period and were followed at participating obstetrics and gynecology clinics.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Gestational Diabetes Mellitus
Tidsramme: 24-28 weeks of gestation
Occurrence of gestational diabetes mellitus diagnosed by the 75-g oral glucose tolerance test performed between 24 and 28 weeks of gestation.
24-28 weeks of gestation

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fetal Macrosomia
Tidsramme: From second trimester until delivery
Presence of fetal macrosomia assessed according to routine obstetric ultrasonographic evaluation and/or birth weight.
From second trimester until delivery

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Polyhydramnios
Tidsramme: From second trimester until delivery
Development of polyhydramnios determined by routine ultrasonographic assessment of amniotic fluid volume during pregnancy.
From second trimester until delivery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. januar 2026

Primær fullføring (Antatt)

31. desember 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

29. mai 2026

Først innsendt som oppfylte QC-kriteriene

29. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LAC-GDM-2026-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared because the study involves patient-level clinical data collected from routine medical records. Data sharing is not included in the current study protocol or ethics committee application, and participant confidentiality and institutional data protection policies will be maintained.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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