Blood Phoenixin-14 Levels and Echocardiographic Findings in Infants of Diabetic Mothers

NCT06891586 | Recruiting

• 1 other identifier: KSH_MB_2025_2
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators hypothesize that echocardiographic pathologies observed in infants of diabetic mothers are associated with elevated serum phoenixin-14 levels.

Conditions

Newborn Morbidity; Newborn Complication

Keywords

NEWBORN; phoenixin-14; Infants of Diabetic Mothers

Outcome Measures

Primary Outcomes (1)

• Correlation between serum phoenixin-14 levels and echocardiographic pathologies in infants of diabetic mothers.

  Measurement Variables: * Serum phoenixin-14 concentration (pg/mL). * Presence of pathologies related to echocardiographic intraventricular septum thickness Analysis Metric: Assessment of the relationship between serum phoenixin-14 levels and echocardiographic intraventricular septum thickness. Data Collection Method: Serum phoenixin-14 levels will be measured using a specific immunoassay, and echocardiographic evaluations will be conducted by a pediatric cardiologist.

  postnatal 5 days

Study Arms (2)

Baby of mother diagnosed with GDM

EXPERIMENTAL

For participants who provide consent, residual blood samples from routine complete blood count tests performed at the 6th postnatal hour will be collected. Additionally, infants included in the study will undergo an echocardiographic evaluation by a pediatric cardiologist between postnatal days 3 and 5.

Diagnostic Test: echocardiographic evaluation and blood phoenixin-14 level

healthy infants

EXPERIMENTAL

For consenting participants, residual blood samples from routine tests (such as complete blood count or jaundice screening) collected at the 6th hour post-birth will be gathered. Additionally, infants included in the study will undergo echocardiographic evaluation by a pediatric cardiologist between the 3rd and 5th days after birth.

Diagnostic Test: echocardiographic evaluation and blood phoenixin-14 level

Interventions

echocardiographic evaluation and blood phoenixin-14 level DIAGNOSTIC_TEST

For participants who provide consent, blood samples will be collected at 6 hours postpartum. Additionally, infants included in the study will undergo an echocardiographic evaluation by a pediatric cardiologist between postnatal days 3 and 5.

Baby of mother diagnosed with GDM; healthy infants

Eligibility Criteria

• Age: 1 Day - 5 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants of diabetic mothers
• Healthy term infants

You may not qualify if:

• Infants whose families did not provide consent
• Infants with a syndromic appearance or congenital heart disease

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Melek Buyukeren

Konya, Karatay, 42020, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• Yosten GL, Lyu RM, Hsueh AJ, Avsian-Kretchmer O, Chang JK, Tullock CW, Dun SL, Dun N, Samson WK. A novel reproductive peptide, phoenixin. J Neuroendocrinol. 2013 Feb;25(2):206-15. doi: 10.1111/j.1365-2826.2012.02381.x.

  PMID: 22963497 BACKGROUND

• Yao B, Lv J, Du L, Zhang H, Xu Z. Phoenixin-14 protects cardiac damages in a streptozotocin-induced diabetes mice model through SIRT3. Arch Physiol Biochem. 2024 Feb;130(1):110-118. doi: 10.1080/13813455.2021.1981946. Epub 2021 Oct 7.

  PMID: 34618648 BACKGROUND

• Yang F, Huang P, Shi L, Liu F, Tang A, Xu S. Phoenixin 14 Inhibits High-Fat Diet-Induced Non-Alcoholic Fatty Liver Disease in Experimental Mice. Drug Des Devel Ther. 2020 Sep 22;14:3865-3874. doi: 10.2147/DDDT.S258857. eCollection 2020.

  PMID: 33061293 BACKGROUND

• Ozdemir-Kumral ZN, Sen E, Yapici HB, Atakul N, Domruk OF, Aldag Y, Sen LS, Kanpalta Mustafaoglu F, Yuksel M, Akakin D, Erzik C, Haklar G, Imeryuz N. Phoenixin 14 ameloriates pancreatic injury in streptozotocin-induced diabetic rats by alleviating oxidative burden. J Pharm Pharmacol. 2022 Nov 4;74(11):1651-1659. doi: 10.1093/jpp/rgac055.

  PMID: 36130115 BACKGROUND

• Yuan T, Sun Z, Zhao W, Wang T, Zhang J, Niu D. Phoenixin: A Newly Discovered Peptide with Multi-Functions. Protein Pept Lett. 2017;24(6):472-475. doi: 10.2174/0929866524666170207154417.

  PMID: 28176660 BACKGROUND

• Billert M, Kolodziejski PA, Strowski MZ, Nowak KW, Skrzypski M. Phoenixin-14 stimulates proliferation and insulin secretion in insulin producing INS-1E cells. Biochim Biophys Acta Mol Cell Res. 2019 Dec;1866(12):118533. doi: 10.1016/j.bbamcr.2019.118533. Epub 2019 Aug 15.

  PMID: 31422055 BACKGROUND

• Wang M, Deng SP, Chen HP, Jiang DN, Tian CX, Yang W, Wu TL, Zhu CH, Zhang Y, Li GL. Phoenixin participated in regulation of food intake and growth in spotted scat, Scatophagus argus. Comp Biochem Physiol B Biochem Mol Biol. 2018 Dec;226:36-44. doi: 10.1016/j.cbpb.2018.07.007. Epub 2018 Aug 13.

  PMID: 30114526 BACKGROUND

• Lende M, Rijhsinghani A. Gestational Diabetes: Overview with Emphasis on Medical Management. Int J Environ Res Public Health. 2020 Dec 21;17(24):9573. doi: 10.3390/ijerph17249573.

  PMID: 33371325 BACKGROUND

Study Officials

• MELEK BUYUKEREN

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MELEK BUYUKEREN

CONTACT

+903323105000; melekbuyukeren@gmail.com

Study Design

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

Model Details: The study will consist of two groups: infants of diabetic mothers and infants of healthy mothers.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 24, 2025
• Study Start: September 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)