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Gestational Diabetes and Human Milk Composition Study

NCT ID: NCT07051681

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Gestational Diabetes Mellitus (GDM)

Keywords

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GDM human milk hormone nutrition therapy postpartum period adiponectin chemerin dermcidin insulin ghrelin leptin

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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GDM

Pregnant women with GDM

Individualized Medical Nutrition Therapy

Intervention Type OTHER

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

Interventions

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Individualized Medical Nutrition Therapy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role collaborator

Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Sule Aktac

Assoc. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marmara University

Maltepe, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BDB-MILK-TRIAL-2025

Identifier Type: -

Identifier Source: org_study_id