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
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