An observational study in Gestatiaonl Diabetes Mellitus, sponsored by Samsun University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Samsun University · Observational
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.
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.
857 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.
This study's enrollment of 75 is below the median of 198 across 274 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Samsun University is the lead sponsor of 86 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
18-45 years were included in the study, comprising 31 patients diagnosed with GDM and 44 healthy pregnant women as controls.
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Exclusion Criteria:
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.
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control
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,
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2025 to primary completion in Jul 2026, 12 months.
Of 133 non-industry observational studies under Diabetes, Gestational, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 70. This study's 12 months is below that.
Counting every sponsor, half of 135 studies reached it within 42 months; a quarter within 23 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Samsun University