Protective Effect of Lactation Against Gestational Diabetes Mellitus in Subsequent Pregnancies: A Prospective Observational Cohort Study (LACGDM)
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Burak D AYDOGDU, MD, OB/GYN
- 電話番号:+90 5396182228
- メール:burakd.1992@hotmail.com
研究場所
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Istanbul、トルコ(Türkiye)、34384
- 募集
- Prof. Dr. Cemil Taşcıoğlu City Hospital
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コンタクト:
- Burak d AYDOGDU, MD
- 電話番号:90 5396182228
- メール:burakd.1992@hotmail.com
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Istanbul、トルコ(Türkiye)、34517
- 募集
- Esenyurt Necmi Kadıoğlu State Hospital
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コンタクト:
- Burak d AYDOGDU, MD
- 電話番号:+90 5396182228
- メール:burakd.1992@hotmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Gestational Diabetes Mellitus
時間枠:24-28 weeks of gestation
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Occurrence of gestational diabetes mellitus diagnosed by the 75-g oral glucose tolerance test performed between 24 and 28 weeks of gestation.
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24-28 weeks of gestation
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Fetal Macrosomia
時間枠:From second trimester until delivery
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Presence of fetal macrosomia assessed according to routine obstetric ultrasonographic evaluation and/or birth weight.
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From second trimester until delivery
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Polyhydramnios
時間枠:From second trimester until delivery
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Development of polyhydramnios determined by routine ultrasonographic assessment of amniotic fluid volume during pregnancy.
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From second trimester until delivery
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- LAC-GDM-2026-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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