Blood Phoenixin-14 Levels and Echocardiographic Findings in Infants of Diabetic Mothers
NCT ID: NCT06891586
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
84 participants
INTERVENTIONAL
2023-09-01
2025-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Phoenixin-14 Levels in Term Babies
NCT06656481
Cord Blood Preptin Levels in Infants
NCT06880003
Fetal Cardiac Function Parameters and HbA1c As Screening for Gestational Diabetes Mellitus
NCT05019508
Serum Vasohibin, Cardiotrophin, Endocan & Perinatal Outcomes
NCT06416995
Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.
NCT04937348
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
So far, two isoforms of phoenixin have been identified: phoenixin-20, which consists of a 20-amino acid peptide, and phoenixin-14, which consists of a 14-amino acid peptide. Both peptides exhibit similar functions.
Maternal diabetes is associated with significant congenital disorders, an increased risk of preterm birth, higher prenatal morbidity, and increased mortality. It can also lead to neonatal hypoglycemia and macrosomia. One of the most concerning effects is its impact on the cardiovascular system, including transient myocardial hypertrophy, which typically resolves within 2-4 weeks after birth. Additionally, it can cause disproportionate septal thickening, left ventricular outflow tract obstruction, transient hypertrophic subaortic stenosis, and heart failure.
Animal studies have shown that phoenixin-14 plays a role in myocardial repair and the regression of cardiac hypertrophy in diabetic mice. Furthermore, phoenixin-14 has been found to significantly reduce severe oxidative stress in diabetic mice.
Existing studies on phoenixin-14 in the literature have focused on adults, and there is currently no research on phoenixin-14 levels in newborns. Based on previous studies, the investigator aim is to investigate whether there is a relationship between blood phoenixin-14 levels and echocardiographic pathologies-particularly myocardial hypertrophy and interventricular septal thickness-in infants of diabetic mothers.
Between September 2023 and October 2025, mothers of infants born to diabetic mothers (study group) at Konya City Hospital will be informed about the study, and written informed consent will be obtained if they agree to participate. Similarly, during the same period, mothers of infants born to healthy mothers (control group) will be informed about the study, and written informed consent will be obtained upon their acceptance.
For participants who provide consent, residual blood samples from routine complete blood count tests performed at the 6th postnatal hour will be collected. These samples will be processed in the biochemistry laboratory, and the serum will be separated and stored at -80°C. Once the target sample size is reached, phoenixin-14 levels will be analyzed in the collected serum samples.
The cost of the kits used for phoenixin-14 testing 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. Additionally, infants included in the study will undergo an echocardiographic evaluation by a pediatric cardiologist between postnatal days 3 and 5.
The study will consist of two groups: infants of diabetic mothers and infants of healthy mothers.
The investigator's study aims to investigate the relationship between phoenixin-14 levels and echocardiographic findings (intraventricular septum thickness) between the study and control groups.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Baby of mother diagnosed with GDM
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.
echocardiographic evaluation and blood phoenixin-14 level
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.
healthy infants
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.
echocardiographic evaluation and blood phoenixin-14 level
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
echocardiographic evaluation and blood phoenixin-14 level
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy term infants
Exclusion Criteria
* Infants with a syndromic appearance or congenital heart disease
1 Day
5 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Konya City Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Melek Buyukeren
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MELEK BUYUKEREN
Role: PRINCIPAL_INVESTIGATOR
Konya City Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Melek Buyukeren
Konya, Karatay, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KSH_MB_2025_2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.