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临床试验/NCT06891586
NCT06891586已完成不适用

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

Konya City Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
84
试验地点
1
主要终点
Correlation between serum phoenixin-14 levels and echocardiographic pathologies in infants of diabetic mothers.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Day 至 5 Days(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Infants of diabetic mothers
  • •Healthy term infants

排除标准

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

研究组 & 干预措施

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.

干预措施: echocardiographic evaluation and blood phoenixin-14 level (Diagnostic Test)

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.

干预措施: echocardiographic evaluation and blood phoenixin-14 level (Diagnostic Test)

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Konya City Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Melek Buyukeren

Associate Professor

Konya City Hospital

研究点 (1)

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