Clinical trial NCT06891586: Blood Phoenixin-14 Levels and Echocardiographic Findings in Infants of Diabetic Mothers
Official title: Investigation of the Relationship Between Phoenixin-14 Levels and Echocardiographic Findings in Infants of Diabetic Mothers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Newborn Morbidity
Newborn Complication
Keywords: NEWBORN
phoenixin-14
Infants of Diabetic Mothers
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 84
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will consist of two groups: infants of diabetic mothers and infants of healthy mothers.
Primary purpose: DIAGNOSTIC

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.

Detailed description: Phoenixin is a neuropeptide that has been discovered in recent years. It was first identified as a reproductive peptide in 2013. However, subsequent studies have demonstrated that phoenixin plays a regulatory role in a wide range of physiological systems, including glucose metabolism, pain perception, appetite, anxiety, and cardiovascular regulation. Phoenixin is highly expressed in various regions of the brain, including the hypothalamus, and has also been detected in circulation and peripheral tissues. Animal studies suggest that phoenixin-14 may have a direct regulatory role in the liver.

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.

Eligibility criteria: Inclusion Criteria:

* Infants of diabetic mothers
* Healthy term infants

Exclusion Criteria:

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

Primary outcomes:
measure: Correlation between serum phoenixin-14 levels and echocardiographic pathologies in infants of diabetic mothers.
timeFrame: postnatal 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Melek Buyukeren
state: Karatay
Study officials:
affiliation: Konya City Hospital
name: MELEK BUYUKEREN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.