Validating CGM for GDM
NCT06858787
Diabetes Mellitus, Diabetes, Gestational
New York, United States
View Trial DetailsNCT Number: NCT07624968
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.
Interested in participating?
Request Info18 year–50 year
Female
Observational
Esenyurt Necmi Kadıoğlu State Hospital, Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: From second trimester until delivery
Presence of fetal macrosomia assessed according to routine obstetric ultrasonographic evaluation and/or birth weight.
Time frame: From second trimester until delivery
Development of polyhydramnios determined by routine ultrasonographic assessment of amniotic fluid volume during pregnancy.
Contact information is provided by the study sponsor or research team.
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Other
Protective Effect of Lactation Against Gestational Diabetes Mellitus in Subsequent Pregnancy: A Prospective Observational Cohort Study
Acronym: LACGDM
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