Gestational Diabetes and Human Milk Composition Study
Effect of Gestational Diabetes Mellitus on Serum Hormone Levels and Human Milk Composition
1 other identifier
observational
40
1 country
1
Brief Summary
This study aims to compare hormone levels and milk composition in women with and without gestational diabetes through postpartum human milk and blood samples.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedFirst Submitted
Initial submission to the registry
June 26, 2025
CompletedFirst Posted
Study publicly available on registry
July 4, 2025
CompletedDecember 30, 2025
December 1, 2025
8 months
June 26, 2025
December 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Serum hormone levels
Measurement of insulin, adiponectin, leptin, ghrelin, chemerin, and dermcidin levels using ELISA in maternal blood serum
Postpartum day 14 and 30
Human milk hormone levels
Measurement of insulin, adiponectin, leptin, ghrelin, chemerin, and dermcidin levels using ELISA in human milk samples
Postpartum day 14 and 30
Secondary Outcomes (1)
Human milk energy and macronutrient content
Postpartum day 14 and 30
Study Arms (1)
GDM
Pregnant women with GDM
Interventions
Pregnant women with GDM received individualized nutrition therapy during pregnancy. No intervention was applied to the control group.
Eligibility Criteria
Voluntary pregnant women attending Zeynep Kamil Women and Children's Hospital obstetrics clinic.
You may qualify if:
- Voluntary pregnant women with singleton pregnancies
- No complications or chronic diseases.
You may not qualify if:
- With pregnant and post-partum complications or chronic diseases
- Mothers who feed their babies with formula
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Marmara University
Maltepe, Istanbul, 34722, Turkey (Türkiye)
Biospecimen
Human milk Blood sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. Dr.
Study Record Dates
First Submitted
June 26, 2025
First Posted
July 4, 2025
Study Start
December 1, 2023
Primary Completion
August 1, 2024
Study Completion
September 30, 2024
Last Updated
December 30, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
Individual participant data that underlie the results (text, tables, figures, and appendices) will be shared after de-identification. Data will be available beginning 6 months after publication, to researchers who provide a methodologically sound proposal.