Newborn MorbidityNCT06880003
Cord Blood Preptin Levels in Infants
A study testing During delivery, blood samples will be collected from the umbilical cord in people with Newborn Morbidity and Newborn Complication, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, cord blood preptin levels in infants with high or low birth weight will be compared to those in infants with normal birth weight. Our aim is to determine whether there is a relationship between birth weight and preptin levels. Read more about this study
- Who is it for?
- Ages 1 minute to 5 minutesHealthy volunteers can take part
- Conditions the study is for
- Newborn Morbidity, Newborn Complication
- What is being tested?
- During delivery, blood samples will be collected from the umbilical cord
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2025to 1 Nov 2025
- Phase
- Interventional
- 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 1 minute to 5 minutes
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Large-for-Gestational-Age (LGA) Infants
- Appropriate-for-Gestational-Age (AGA) Infants
- Small-for-Gestational-Age (SGA) Infants
- Infants of Diabetic Mothers (IDM)
Who cannot join
- Infants with a syndromic appearance or any accompanying disease
- Infants whose families did not provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cord Blood Preptin Levels in Infants With Low and High Birth Weight for Gestational Age and Infants of Diabetic Mothers With Those of Normal Birth Weight Infants
In this study, cord blood preptin levels in infants with high or low birth weight will be compared to those in infants with normal birth weight. Our aim is to determine whether there is a relationship between birth weight and preptin levels. Additionally, we plan to compare the cord blood preptin levels of infants of diabetic mothers with those of normal birth weight infants.
Read the detailed description
Preptin is the youngest identified member of the insulin family. It is a 34-amino acid protein derived from the E-peptide of pro-insulin-like growth factor 2. Preptin was first isolated in 2001 from the β-cell islet granules of the rat pancreas. It is co-secreted with insulin. In vitro studies have shown that preptin enhances insulin secretion in a dose-dependent manner under high glucose conditions; however, this effect is not observed under normal conditions. Nevertheless, the systemic effects of preptin on glucose metabolism are still not fully understood.
Initial clinical studies have found higher plasma preptin concentrations in patients with type 2 diabetes mellitus compared to individuals with impaired glucose tolerance and healthy controls. Moreover, preptin is linked to insulin resistance by enhancing glucose-mediated insulin secretion. Consequently, elevated preptin levels have been observed in insulin resistance-related conditions such as polycystic ovary syndrome, gestational diabetes, and type 2 diabetes mellitus. In a study serum preptin levels in pregnant women with gestational diabetes were found to be significantly higher than in the control group.
Existing studies on preptin in the literature primarily focus on adults, and there is no comprehensive research on preptin levels in newborns. Based on the available literature, the investigator study aims to compare cord blood preptin levels in infants with high or low birth weight for gestational age and infants of diabetic mothers with those of normal birth weight infants. Through this comparison, The investigators seek to determine whether there is a relationship between preptin levels and an infant's birth weight or the presence of gestational diabetes in the mother.
Between March 2025 and November 2025, mothers of infants born at Konya City Hospital who have either high or low birth weight for their gestational age or are infants of diabetic mothers (study group) will be informed about the study. If they agree to participate, written informed consent will be obtained. Similarly, during the same period, mothers of infants estimated to have normal birth weight for their gestational age (control group) will be informed about the study, and written informed consent will be obtained if they agree to participate.
Blood samples collected from the umbilical cord at birth will be processed in the biochemistry laboratory, and the serum will be separated and stored at -80°C. After reaching the target sample size, preptin levels will be analyzed. The cost of the kits used for the preptin test will be covered by the researchers.
The demographic and clinical characteristics of the patients, as well as prenatal and postnatal risk factors, will be recorded in a patient data collection form. In the investigator's study, preptin levels will be examined in infants of diabetic mothers, infants with high birth weight from healthy mothers, normal birth weight infants, and infants with low birth weight for their gestational age.
No invasive procedures or additional blood sampling will be performed on the patients for the study. The blood samples used will be obtained from residual umbilical cord blood collected for routine tests such as blood gas analysis and blood typing.
- Conditions
- Newborn Morbidity, Newborn Complication
- Being tested
- During delivery, blood samples will be collected from the umbilical cord
- Keywords
- NEWBORN, preptin, UMBİLİCAL CORD BLOOD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
During delivery, blood samples will be collected from the umbilical cordOther
During delivery, blood samples will be collected from the umbilical cord of pregnant women who agree to participate in the study.
| Study group | Role | What they receive |
|---|---|---|
| Appropriate for gestational age | Experimental | During delivery, blood samples will be collected from the umbilical cord of pregnant women who agree to participate in the study. Receives: Other: During delivery, blood samples will be collected from the umbilical cord |
| small for gestational age | Experimental | During delivery, blood samples will be collected from the umbilical cord of pregnant women who agree to participate in the study. Receives: Other: During delivery, blood samples will be collected from the umbilical cord |
| large for gestational age | Experimental | During delivery, blood samples will be collected from the umbilical cord of pregnant women who agree to participate in the study. Receives: Other: During delivery, blood samples will be collected from the umbilical cord |
| Baby of mother diagnosed with GDM | Experimental | During delivery, blood samples will be collected from the umbilical cord of pregnant women who agree to participate in the study. Receives: Other: During delivery, blood samples will be collected from the umbilical cord |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum preptin level
The primary outcome variable is the comparison of serum preptin levels between large-for-gestational-age infants and infants of diabetic mothers with those of normal birth weight infants.The other variable is the comparison of serum preptin levels in small-for-gestational-age infants based on gestational age.
Measured: postnatal 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start10 Mar 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Newborn MorbidityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Between March 2025 and November 2025, mothers of infants born at Konya City Hospital who have either high or low birth weight for their gestational age or are infants of diabetic mothers (study group) will be informed about the study. If they agree to participate, written informed consent will be obtained. Similarly, during the same period, mothers of infants estimated to have normal birth weight for their gestational age (control group) will be informed about the study, and written informed consent will be obtained if they agree to participate. Blood samples collected from the umbilical cord at birth will be processed in the biochemistry laboratory, and the serum will be separated and stored at -80°C. After reaching the target sample size, preptin levels will be analyzed. The cost of the kits used for the preptin test will be covered by the researchers.
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Buyukeren, Konya City Hospital
- Investigators
- MELEK BUYUKEREN, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880003
- Sponsor's protocol ID
- KSH_MB_2025_1
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the study is published as a scientific article, it can be shared.
Publications
Ungureanu MC, Bilha SC, Hogas M, Velicescu C, Leustean L, Teodoriu LC, Preda C. Preptin: A New Bone Metabolic Parameter? Metabolites. 2023 Sep 4;13(9):991. doi: 10.3390/metabo13090991.
PubMed 37755271Aydin S. Three new players in energy regulation: preptin, adropin and irisin. Peptides. 2014 Jun;56:94-110. doi: 10.1016/j.peptides.2014.03.021. Epub 2014 Apr 8.
PubMed 24721335Buchanan CM, Phillips AR, Cooper GJ. Preptin derived from proinsulin-like growth factor II (proIGF-II) is secreted from pancreatic islet beta-cells and enhances insulin secretion. Biochem J. 2001 Dec 1;360(Pt 2):431-9. doi: 10.1042/0264-6021:3600431.
PubMed 11716772Cheng KC, Li YX, Asakawa A, Ushikai M, Kato I, Sato Y, Cheng JT, Inui A. Characterization of preptin-induced insulin secretion in pancreatic beta-cells. J Endocrinol. 2012 Oct;215(1):43-9. doi: 10.1530/JOE-12-0176. Epub 2012 Jul 11.
PubMed 22787110Yang G, Li L, Chen W, Liu H, Boden G, Li K. Circulating preptin levels in normal, impaired glucose tolerance, and type 2 diabetic subjects. Ann Med. 2009;41(1):52-6. doi: 10.1080/07853890802244142.
PubMed 18618352Celik O, Celik N, Hascalik S, Sahin I, Aydin S, Ozerol E. An appraisal of serum preptin levels in PCOS. Fertil Steril. 2011 Jan;95(1):314-6. doi: 10.1016/j.fertnstert.2010.08.058.
PubMed 20883990Aslan M, Celik O, Karsavuran N, Celik N, Dogan DG, Botan E, Kafkasli A. Maternal serum and cord blood preptin levels in gestational diabetes mellitus. J Perinatol. 2011 May;31(5):350-5. doi: 10.1038/jp.2010.125. Epub 2010 Dec 16.
PubMed 21164426Kirac UI, Demir E, Ozkan H, Sahtiyanci B, Uzun H, Ekinci I, Buyukkaba M, Durmus S, Akarsu M, Gelisgen R, Tabak O. Maternal serum preptin levels in the pathogenesis and diagnosis of Gestational diabetes mellitus. J Med Biochem. 2023 Mar 15;42(2):311-317. doi: 10.5937/jomb0-36287.
PubMed 36987416
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cord Blood Preptin Levels in Infants With Low and High Birth Weight for Gestational Age and Infants of Diabetic Mothers With Those of Normal Birth Weight Infants
- ClinicalTrials.gov ID
- NCT06880003
- Acronym / sponsor ID
- KSH_MB_2025_1
- Conditions
- Newborn Morbidity, Newborn Complication
- Keywords
- NEWBORN, preptin, UMBİLİCAL CORD BLOOD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 17 Mar 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.
In this study, cord blood preptin levels in infants with high or low birth weight will be compared to those in infants with normal birth weight. Our aim is to determine whether there is a relationship between birth weight and preptin levels. Additionally, we plan to compare the cord blood preptin levels of infants of diabetic mothers with those of normal birth weight infants.
Detailed description
Preptin is the youngest identified member of the insulin family. It is a 34-amino acid protein derived from the E-peptide of pro-insulin-like growth factor 2. Preptin was first isolated in 2001 from the β-cell islet granules of the rat pancreas. It is co-secreted with insulin. In vitro studies have shown that preptin enhances insulin secretion in a dose-dependent manner under high glucose conditions; however, this effect is not observed under normal conditions. Nevertheless, the systemic effects of preptin on glucose metabolism are still not fully understood.
Initial clinical studies have found higher plasma preptin concentrations in patients with type 2 diabetes mellitus compared to individuals with impaired glucose tolerance and healthy controls. Moreover, preptin is linked to insulin resistance by enhancing glucose-mediated insulin secretion. Consequently, elevated preptin levels have been observed in insulin resistance-related conditions such as polycystic ovary syndrome, gestational diabetes, and type 2 diabetes mellitus. In a study serum preptin levels in pregnant women with gestational diabetes were found to be significantly higher than in the control group.
Existing studies on preptin in the literature primarily focus on adults, and there is no comprehensive research on preptin levels in newborns. Based on the available literature, the investigator study aims to compare cord blood preptin levels in infants with high or low birth weight for gestational age and infants of diabetic mothers with those of normal birth weight infants. Through this comparison, The investigators seek to determine whether there is a relationship between preptin levels and an infant's birth weight or the presence of gestational diabetes in the mother.
Between March 2025 and November 2025, mothers of infants born at Konya City Hospital who have either high or low birth weight for their gestational age or are infants of diabetic mothers (study group) will be informed about the study. If they agree to participate, written informed consent will be obtained. Similarly, during the same period, mothers of infants estimated to have normal birth weight for their gestational age (control group) will be informed about the study, and written informed consent will be obtained if they agree to participate.
Blood samples collected from the umbilical cord at birth will be processed in the biochemistry laboratory, and the serum will be separated and stored at -80°C. After reaching the target sample size, preptin levels will be analyzed. The cost of the kits used for the preptin test will be covered by the researchers.
The demographic and clinical characteristics of the patients, as well as prenatal and postnatal risk factors, will be recorded in a patient data collection form. In the investigator's study, preptin levels will be examined in infants of diabetic mothers, infants with high birth weight from healthy mothers, normal birth weight infants, and infants with low birth weight for their gestational age.
No invasive procedures or additional blood sampling will be performed on the patients for the study. The blood samples used will be obtained from residual umbilical cord blood collected for routine tests such as blood gas analysis and blood typing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Between March 2025 and November 2025, mothers of infants born at Konya City Hospital who have either high or low birth weight for their gestational age or are infants of diabetic mothers (study group) will be informed about the study. If they agree to participate, written informed consent will be obtained. Similarly, during the same period, mothers of infants estimated to have normal birth weight for their gestational age (control group) will be informed about the study, and written informed consent will be obtained if they agree to participate. Blood samples collected from the umbilical cord at birth will be processed in the biochemistry laboratory, and the serum will be separated and stored at -80°C. After reaching the target sample size, preptin levels will be analyzed. The cost of the kits used for the preptin test will be covered by the researchers.
| Arm | Type | Receives |
|---|---|---|
| Appropriate for gestational age | Experimental | Other: During delivery, blood samples will be collected from the umbilical cordDuring delivery, blood samples will be collected from the umbilical cord of pregnant women who agree to participate in the study. |
| small for gestational age | Experimental | Other: During delivery, blood samples will be collected from the umbilical cordDuring delivery, blood samples will be collected from the umbilical cord of pregnant women who agree to participate in the study. |
| large for gestational age | Experimental | Other: During delivery, blood samples will be collected from the umbilical cordDuring delivery, blood samples will be collected from the umbilical cord of pregnant women who agree to participate in the study. |
| Baby of mother diagnosed with GDM | Experimental | Other: During delivery, blood samples will be collected from the umbilical cordDuring delivery, blood samples will be collected from the umbilical cord of pregnant women who agree to participate in the study. |
Who may qualify
- Ages
- 1 minute to 5 minutes
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Large-for-Gestational-Age (LGA) Infants
- Appropriate-for-Gestational-Age (AGA) Infants
- Small-for-Gestational-Age (SGA) Infants
- Infants of Diabetic Mothers (IDM)
Key exclusion criteria (2 listed)
- Infants with a syndromic appearance or any accompanying disease
- Infants whose families did not provide consent
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 |
|---|---|---|
| During delivery, blood samples will be collected from the umbilical cordDuring delivery, blood samples will be collected from the umbilical cord of pregnant women who agree to participate in the study. | Other | Appropriate for gestational age, Baby of mother diagnosed with GDM, large for gestational age, small for gestational age |
Primary outcome
serum preptin level
Time frame: postnatal 5 minutes
The primary outcome variable is the comparison of serum preptin levels between large-for-gestational-age infants and infants of diabetic mothers with those of normal birth weight infants.The other variable is the comparison of serum preptin levels in small-for-gestational-age infants based on gestational age.
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 27 Mar 2026.
- Background: PubMed 37755271Ungureanu MC, Bilha SC, Hogas M, Velicescu C, Leustean L, Teodoriu LC, Preda C. Preptin: A New Bone Metabolic Parameter? Metabolites. 2023 Sep 4;13(9):991. doi: 10.3390/metabo13090991.
- Background: PubMed 24721335Aydin S. Three new players in energy regulation: preptin, adropin and irisin. Peptides. 2014 Jun;56:94-110. doi: 10.1016/j.peptides.2014.03.021. Epub 2014 Apr 8.
- Background: PubMed 11716772Buchanan CM, Phillips AR, Cooper GJ. Preptin derived from proinsulin-like growth factor II (proIGF-II) is secreted from pancreatic islet beta-cells and enhances insulin secretion. Biochem J. 2001 Dec 1;360(Pt 2):431-9. doi: 10.1042/0264-6021:3600431.
- Background: PubMed 22787110Cheng KC, Li YX, Asakawa A, Ushikai M, Kato I, Sato Y, Cheng JT, Inui A. Characterization of preptin-induced insulin secretion in pancreatic beta-cells. J Endocrinol. 2012 Oct;215(1):43-9. doi: 10.1530/JOE-12-0176. Epub 2012 Jul 11.
- Background: PubMed 18618352Yang G, Li L, Chen W, Liu H, Boden G, Li K. Circulating preptin levels in normal, impaired glucose tolerance, and type 2 diabetic subjects. Ann Med. 2009;41(1):52-6. doi: 10.1080/07853890802244142.
- Background: PubMed 20883990Celik O, Celik N, Hascalik S, Sahin I, Aydin S, Ozerol E. An appraisal of serum preptin levels in PCOS. Fertil Steril. 2011 Jan;95(1):314-6. doi: 10.1016/j.fertnstert.2010.08.058.
- Background: PubMed 21164426Aslan M, Celik O, Karsavuran N, Celik N, Dogan DG, Botan E, Kafkasli A. Maternal serum and cord blood preptin levels in gestational diabetes mellitus. J Perinatol. 2011 May;31(5):350-5. doi: 10.1038/jp.2010.125. Epub 2010 Dec 16.
- Background: PubMed 36987416Kirac UI, Demir E, Ozkan H, Sahtiyanci B, Uzun H, Ekinci I, Buyukkaba M, Durmus S, Akarsu M, Gelisgen R, Tabak O. Maternal serum preptin levels in the pathogenesis and diagnosis of Gestational diabetes mellitus. J Med Biochem. 2023 Mar 15;42(2):311-317. doi: 10.5937/jomb0-36287.
- Individual participant dataSharing planned: No. Once the study is published as a scientific article, it can be shared.
Related trials for Newborn Morbidity
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Active, not recruitingPhase 2
MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas
Plexiform Neurofibroma, Neurofibromatosis Type 1 (NF1)
RecruitingObservational study
Donor Site Morbidity and Buccinator Muscle Integrity After Buccinator Myomucosal Flap Surgery in Patients With Velopharyngeal Incompetence
Donor Site, Morbidity
Not yet recruitingPhase 3
Gestational Hypertension and Preeclampsia Blood Pressure (BP) Treatment Goals Less Than 140/90 vs. Less Than 160/110 mmHg: The GOALPOST Trial
Hypertension in Pregnancy, Obstetrical Complications
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.
MELEK BUYUKEREN principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing During delivery, blood samples will be collected from the umbilical cord in people with Newborn Morbidity and Newborn Complication, run by Konya City Hospital 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 4 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 27 Mar 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?
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 preptin level (time frame: postnatal 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06880003, which also lists 8 linked publications.
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 27 Mar 2026.