NCT06880003

Brief 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. Additionally, we plan to compare the cord blood preptin levels of infants of diabetic mothers with those of normal birth weight infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 11, 2025

Last Update Submit

March 26, 2026

Conditions

Keywords

NEWBORNpreptinUMBİLİCAL CORD BLOOD

Outcome Measures

Primary Outcomes (1)

  • 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.

    postnatal 5 minutes

Study Arms (4)

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.

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.

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.

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.

Other: During delivery, blood samples will be collected from the umbilical cord

Interventions

During delivery, blood samples will be collected from the umbilical cord of pregnant women who agree to participate in the study.

Appropriate for gestational ageBaby of mother diagnosed with GDMlarge for gestational agesmall for gestational age

Eligibility Criteria

Age1 Minute - 5 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Large-for-Gestational-Age (LGA) Infants
  • Appropriate-for-Gestational-Age (AGA) Infants
  • Small-for-Gestational-Age (SGA) Infants
  • Infants of Diabetic Mothers (IDM)

You may not qualify if:

  • Infants with a syndromic appearance or any accompanying disease
  • Infants whose families did not provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melek Buyukeren

Konya, Karatay, 42020, Turkey (Türkiye)

Location

Related Publications (8)

  • 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.

    PMID: 37755271BACKGROUND
  • Aydin 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.

    PMID: 24721335BACKGROUND
  • Buchanan 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.

    PMID: 11716772BACKGROUND
  • Cheng 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.

    PMID: 22787110BACKGROUND
  • Yang 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.

    PMID: 18618352BACKGROUND
  • Celik 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.

    PMID: 20883990BACKGROUND
  • Aslan 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.

    PMID: 21164426BACKGROUND
  • Kirac 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.

    PMID: 36987416BACKGROUND

Study Officials

  • MELEK BUYUKEREN

    Konya City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

March 10, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

March 27, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Once the study is published as a scientific article, it can be shared.

Locations