Gestational Diabetes and Human Milk Composition Study | NCT07051681

Studies
Gestational Diabetes and Human Milk Composition Study

NCT07051681

Sponsor

Marmara University

Status

Completed

Last Update Posted

Dec 30, 2025Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Gestational Diabetes Mellitus (GDM)

Interventions

Individualized Medical Nutrition Therapy

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Actual

Primary Completion Date

Aug 1, 2024Actual

Completion Date

Sep 30, 2024Actual

First Submitted Date

Jun 26, 2025

First Submission Date that Met QC Criteria

Jun 26, 2025

First Posted Date

Jul 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2025

Last Update Posted Date

Dec 30, 2025Actual

Name	Class
Zeynep Kamil Maternity and Pediatric Research and Training Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GDM		Pregnant women with GDM	Other: Individualized Medical Nutrition Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Individualized Medical Nutrition Therapy	Other	Pregnant women with GDM received individualized nutrition therapy during pregnancy. No intervention was applied to the control group.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Human milk energy and macronutrient content	Analysis of energy, protein, fat, and lactose content in milk	Postpartum day 14 and 30

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Voluntary pregnant women attending Zeynep Kamil Women and Children's Hospital obstetrics clinic.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marmara University		Maltepe	Istanbul	34722	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided