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Completed

NCT Number: NCT06891586

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

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

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Key information

Age range

1 day–5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Melek Buyukeren

Konya, Karatay, 42020, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: postnatal 5 days

    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.

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Investigation of the Relationship Between Phoenixin-14 Levels and Echocardiographic Findings in Infants of Diabetic Mothers

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 24, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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