Gestatiaonl Diabetes MellitusMST1 LevelsNCT07878455
Maternal and Cord Blood MST1 Levels in Gestational Diabetes Mellitus
An observational study of Gestatiaonl Diabetes Mellitus, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
In pregnancies with gestational diabetes (GDM), a protein called MST1 is significantly higher in both mothers and baby cord blood. This suggests MST1 plays a key role in the disease. However, because patients managed their blood sugar well, these high levels did not cause short-term health problems. 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
- Gestatiaonl Diabetes Mellitus
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 1 Dec 2026
- How long will I take part?
- 10 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 18-45 years were included in the study, comprising 31 patients diagnosed with GDM and 44 healthy pregnant women as controls.
Who may be able to join
- 18-45 years gestational diabet and healty pregnant women
Who cannot join
- pre-existing diabetes mellitus, hypertension, renal failure, chronic liver disease, pulmonary or cardiovascular disease, multiple pregnancies, fetal demise, major fetal anomalies (fatal or requiring surgical intervention), chromosomal abnormalities, alcohol use.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal and Cord Blood MST1 Levels Are Elevated in Gestational Diabetes Mellitus
In pregnancies with gestational diabetes (GDM), a protein called MST1 is significantly higher in both mothers and baby cord blood. This suggests MST1 plays a key role in the disease. However, because patients managed their blood sugar well, these high levels did not cause short-term health problems. This is also the very first study to check MST1 in both mothers and babies.
Read the detailed description
Maternal and cord blood MST1 levels are significantly elevated in pregnancies complicated by GDM, suggesting a role in the underlying pathophysiology. However, MST1 does not appear to be associated with short-term clinical outcomes, possibly due to effective glycemic control. To our knowledge, this is the first study to evaluate MST1 in both maternal and fetal sections in pregnancies complicated by gestational diabetes.
- Conditions
- Gestatiaonl Diabetes Mellitus
- Keywords
- Gestational Diabetes Mellitus (GDM), Mammalian sterile 20-like kinase 1 (MST1), cord blood, biomarker, pregnancy
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| gestational diabetes mellitus | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal serum Mst1 and cor blood MST1 levels will be collected
Maternal demographic and clinical data, including age, gravida, parity, gestational age, and body mass index (BMI), will be recorded for all participants. Gestational age was determined based on the last menstrual period and/or first-trimester ultrasound findings. All participants underwent physical examination, obstetric ultrasound, and routine laboratory testing. All participants underwent a 75-g oral glucose tolerance test (OGTT) between 24 and 28 weeks of gestation following an overnight fast of at least 8 hours. Maternal venous blood samples were collected in the morning after an overnight fast under standardized conditions to minimize circadian and metabolic variability. Cord blood samples were obtained immediately after delivery from the umbilical vein using a standardized protocol. Serum MST1 levels will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit. Obstetric and neonatal outcomes will be recorded,
Measured: 1 year
Obstetric and neonatal outcomes will be recorded
Obstetric and neonatal outcomes will be recorded, including gestational age at delivery, mode of delivery, birth weight, 1st- and 5th-minute Apgar scores, and neonatal intensive care unit (NICU) admission, transient tachypnea of the newborn (TTN), respiratory distress syndrome (RDS), and intubated infants. Maternal and perinatal outcomes will be compared with serum and cord blood MST-1 levels.
Measured: 6 month
Maternal characteristics affecting MST1 levels will be determined.
It will be evaluated whether maternal demographic characteristics and blood parameters influence serum and cord MST1 levels.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Jul 2025
- Primary completion1 Jul 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestatiaonl Diabetes MellitusStudies 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
- 75 participants (actual)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878455
- Sponsor's protocol ID
- SamsunUniversit KAEK-2023/5/15
- Acronym
- MST1 Levels
- Status last verified
- Oct 2026
- First submitted
- 18 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal and Cord Blood MST1 Levels Are Elevated in Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07878455
- Acronym / sponsor ID
- MST1 Levels / SamsunUniversit KAEK-2023/5/15
- Conditions
- Gestatiaonl Diabetes Mellitus
- Keywords
- Gestational Diabetes Mellitus (GDM), Mammalian sterile 20-like kinase 1 (MST1), cord blood, biomarker, pregnancy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Oct 2026 (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.
In pregnancies with gestational diabetes (GDM), a protein called MST1 is significantly higher in both mothers and baby cord blood. This suggests MST1 plays a key role in the disease. However, because patients managed their blood sugar well, these high levels did not cause short-term health problems. This is also the very first study to check MST1 in both mothers and babies.
Detailed description
Maternal and cord blood MST1 levels are significantly elevated in pregnancies complicated by GDM, suggesting a role in the underlying pathophysiology. However, MST1 does not appear to be associated with short-term clinical outcomes, possibly due to effective glycemic control. To our knowledge, this is the first study to evaluate MST1 in both maternal and fetal sections in pregnancies complicated by gestational diabetes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gestational diabetes mellitus | – | –control |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 18-45 years were included in the study, comprising 31 patients diagnosed with GDM and 44 healthy pregnant women as controls.
Key inclusion criteria (1 listed)
- 18-45 years gestational diabet and healty pregnant women
Key exclusion criteria (2 listed)
- pre-existing diabetes mellitus, hypertension, renal failure, chronic liver disease, pulmonary or cardiovascular disease, multiple pregnancies, fetal demise, major fetal anomalies (fatal or requiring surgical intervention), chromosomal abnormalities, alcohol use.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maternal serum Mst1 and cor blood MST1 levels will be collected
Time frame: 1 year
Maternal demographic and clinical data, including age, gravida, parity, gestational age, and body mass index (BMI), will be recorded for all participants. Gestational age was determined based on the last menstrual period and/or first-trimester ultrasound findings. All participants underwent physical examination, obstetric ultrasound, and routine laboratory testing. All participants underwent a 75-g oral glucose tolerance test (OGTT) between 24 and 28 weeks of gestation following an overnight fast of at least 8 hours. Maternal venous blood samples were collected in the morning after an overnight fast under standardized conditions to minimize circadian and metabolic variability. Cord blood samples were obtained immediately after delivery from the umbilical vein using a standardized protocol. Serum MST1 levels will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit. Obstetric and neonatal outcomes will be recorded,
Obstetric and neonatal outcomes will be recorded
Time frame: 6 month
Obstetric and neonatal outcomes will be recorded, including gestational age at delivery, mode of delivery, birth weight, 1st- and 5th-minute Apgar scores, and neonatal intensive care unit (NICU) admission, transient tachypnea of the newborn (TTN), respiratory distress syndrome (RDS), and intubated infants. Maternal and perinatal outcomes will be compared with serum and cord blood MST-1 levels.
Maternal characteristics affecting MST1 levels will be determined.
Time frame: 6 months
It will be evaluated whether maternal demographic characteristics and blood parameters influence serum and cord MST1 levels.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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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 Gestatiaonl Diabetes Mellitus, run by Samsun 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 1 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Maternal serum Mst1 and cor blood MST1 levels will be collected (time frame: 1 year). The study lists 3 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 16 Oct 2026.