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Completed

NCT Number: NCT07051681

Gestational Diabetes and Human Milk Composition Study

This study aims to compare hormone levels and milk composition in women with and without gestational diabetes through postpartum human milk and blood samples.

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Marmara University

Maltepe, Istanbul, 34722, Turkey (Türkiye)

About this study

Pregnant women with GDM who received medical nutrition therapy and healthy controls were evaluated on postpartum days 14 and 30. Human milk and blood samples, as well as 3-day food consumption records, were collected. Levels of insulin, adiponectin, leptin, ghrelin, chemerin, and dermcidin in blood and milk were measured and compared with macronutrient contents of milk.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Voluntary pregnant women with singleton pregnancies
  • No complications or chronic diseases.

Exclusion criteria

  • With pregnant and post-partum complications or chronic diseases
  • Mothers who feed their babies with formula

Treatment and study plan

Individualized Medical Nutrition Therapy

Other

Pregnant women with GDM received individualized nutrition therapy during pregnancy. No intervention was applied to the control group.

Primary outcomes

  1. Serum hormone levels

    Time frame: Postpartum day 14 and 30

    Measurement of insulin, adiponectin, leptin, ghrelin, chemerin, and dermcidin levels using ELISA in maternal blood serum

  2. Human milk hormone levels

    Time frame: Postpartum day 14 and 30

    Measurement of insulin, adiponectin, leptin, ghrelin, chemerin, and dermcidin levels using ELISA in human milk samples

Secondary outcomes

  1. Human milk energy and macronutrient content

    Time frame: Postpartum day 14 and 30

    Analysis of energy, protein, fat, and lactose content in milk

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Collaborators

  • Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Registry information

Official study title

Effect of Gestational Diabetes Mellitus on Serum Hormone Levels and Human Milk Composition

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 4, 2025
Registry last updated
Dec 30, 2025

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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