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Gestational Diabetes and Human Milk Composition Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07051681
Enrollment
40
Registered
2025-07-04
Start date
2023-12-01
Completion date
2024-09-30
Last updated
2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

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

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.

Detailed description

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.

Interventions

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

Sponsors

Zeynep Kamil Maternity and Pediatric Research and Training Hospital
CollaboratorOTHER
Marmara University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Serum hormone levelsPostpartum day 14 and 30Measurement of insulin, adiponectin, leptin, ghrelin, chemerin, and dermcidin levels using ELISA in maternal blood serum
Human milk hormone levelsPostpartum day 14 and 30Measurement of insulin, adiponectin, leptin, ghrelin, chemerin, and dermcidin levels using ELISA in human milk samples

Secondary

MeasureTime frameDescription
Human milk energy and macronutrient contentPostpartum day 14 and 30Analysis of energy, protein, fat, and lactose content in milk

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026