Gestational Diabetes Mellitus (GDM)NCT07051681
Gestational Diabetes and Human Milk Composition Study
An observational study of Gestational Diabetes Mellitus (GDM), run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Individualized Medical Nutrition Therapy
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Voluntary pregnant women attending Zeynep Kamil Women and Children's Hospital obstetrics clinic.
Who may be able to join
- Voluntary pregnant women with singleton pregnancies
- No complications or chronic diseases.
Who cannot join
- With pregnant and post-partum complications or chronic diseases
- Mothers who feed their babies with formula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Gestational Diabetes Mellitus on Serum Hormone Levels and Human Milk Composition
This study aims to compare hormone levels and milk composition in women with and without gestational diabetes through postpartum human milk and blood samples.
Read the 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.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Individualized Medical Nutrition Therapy
- Keywords
- GDM, human milk, hormone, nutrition therapy, postpartum period, adiponectin, chemerin, dermcidin, insulin, ghrelin, leptin
- Medical subject headings
- Diabetes, Gestational, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Medical Nutrition TherapyOther
Pregnant women with GDM received individualized nutrition therapy during pregnancy. No intervention was applied to the control group.
| Study group | Role | What they receive |
|---|---|---|
| GDM | Pregnant women with GDM Receives: Other: Individualized Medical Nutrition Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum hormone levels
Measurement of insulin, adiponectin, leptin, ghrelin, chemerin, and dermcidin levels using ELISA in maternal blood serum
Measured: 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
Measured: Postpartum day 14 and 30
Secondary outcomes (1)
Human milk energy and macronutrient content
Analysis of energy, protein, fat, and lactose content in milk
Measured: Postpartum day 14 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Dec 2023
- Primary completion1 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Responsible party
- Principal investigator, Sule Aktac, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051681
- Sponsor's protocol ID
- BDB-MILK-TRIAL-2025
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gestational Diabetes Mellitus on Serum Hormone Levels and Human Milk Composition
- ClinicalTrials.gov ID
- NCT07051681
- Acronym / sponsor ID
- BDB-MILK-TRIAL-2025
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- GDM, human milk, hormone, nutrition therapy, postpartum period, adiponectin, chemerin, dermcidin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GDM | – | Other: Individualized Medical Nutrition TherapyPregnant women with GDM |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Voluntary pregnant women attending Zeynep Kamil Women and Children's Hospital obstetrics clinic.
Key inclusion criteria (2 listed)
- Voluntary pregnant women with singleton pregnancies
- No complications or chronic diseases.
Key exclusion criteria (2 listed)
- With pregnant and post-partum complications or chronic diseases
- Mothers who feed their babies with formula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Medical Nutrition TherapyPregnant women with GDM received individualized nutrition therapy during pregnancy. No intervention was applied to the control group. | Other | GDM |
Primary outcome
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
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
1 secondary outcome
Human milk energy and macronutrient content
Time frame: Postpartum day 14 and 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus (GDM), run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum hormone levels (time frame: Postpartum day 14 and 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.