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

March 26, 2026 updated by: Melek Buyukeren, Konya City Hospital

Investigation of the Relationship Between 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: 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.
Experimental: 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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postnatal 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya City Hospital

Investigators

  • Principal Investigator: MELEK BUYUKEREN, Konya City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 24, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSH_MB_2025_2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Newborn Morbidity

Clinical Trials on echocardiographic evaluation and blood phoenixin-14 level

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe