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临床试验/NCT06880003
NCT06880003招募中不适用

Comparison of Cord Blood Preptin Levels in Infants With Low and High Birth Weight for Gestational Age and Infants of Diabetic Mothers With Those of Normal Birth Weight Infants

Konya City Hospital2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年3月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
serum preptin level

研究概览

简要总结

In this study, cord blood preptin levels in infants with high or low birth weight will be compared to those in infants with normal birth weight. Our aim is to determine whether there is a relationship between birth weight and preptin levels. Additionally, we plan to compare the cord blood preptin levels of infants of diabetic mothers with those of normal birth weight infants.

详细描述

Preptin is the youngest identified member of the insulin family. It is a 34-amino acid protein derived from the E-peptide of pro-insulin-like growth factor 2. Preptin was first isolated in 2001 from the β-cell islet granules of the rat pancreas. It is co-secreted with insulin. In vitro studies have shown that preptin enhances insulin secretion in a dose-dependent manner under high glucose conditions; however, this effect is not observed under normal conditions. Nevertheless, the systemic effects of preptin on glucose metabolism are still not fully understood.

Initial clinical studies have found higher plasma preptin concentrations in patients with type 2 diabetes mellitus compared to individuals with impaired glucose tolerance and healthy controls. Moreover, preptin is linked to insulin resistance by enhancing glucose-mediated insulin secretion. Consequently, elevated preptin levels have been observed in insulin resistance-related conditions such as polycystic ovary syndrome, gestational diabetes, and type 2 diabetes mellitus. In a study serum preptin levels in pregnant women with gestational diabetes were found to be significantly higher than in the control group.

Existing studies on preptin in the literature primarily focus on adults, and there is no comprehensive research on preptin levels in newborns. Based on the available literature, the investigator study aims to compare cord blood preptin levels in infants with high or low birth weight for gestational age and infants of diabetic mothers with those of normal birth weight infants. Through this comparison, The investigators seek to determine whether there is a relationship between preptin levels and an infant's birth weight or the presence of gestational diabetes in the mother.

Between March 2025 and November 2025, mothers of infants born at Konya City Hospital who have either high or low birth weight for their gestational age or are infants of diabetic mothers (study group) will be informed about the study. If they agree to participate, written informed consent will be obtained. Similarly, during the same period, mothers of infants estimated to have normal birth weight for their gestational age (control group) will be informed about the study, and written informed consent will be obtained if they agree to participate.

Blood samples collected from the umbilical cord at birth will be processed in the biochemistry laboratory, and the serum will be separated and stored at -80°C. After reaching the target sample size, preptin levels will be analyzed. The cost of the kits used for the preptin test will be covered by the researchers.

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 Minute 至 5 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • Large-for-Gestational-Age (LGA) Infants
  • Appropriate-for-Gestational-Age (AGA) Infants
  • Small-for-Gestational-Age (SGA) Infants
  • Infants of Diabetic Mothers (IDM)

排除标准

  • Infants with a syndromic appearance or any accompanying disease
  • Infants whose families did not provide consent

结局指标

主要结局

serum preptin level

时间窗: postnatal 5 minutes

The primary outcome variable is the comparison of serum preptin levels between large-for-gestational-age infants and infants of diabetic mothers with those of normal birth weight infants.The other variable is the comparison of serum preptin levels in small-for-gestational-age infants based on gestational age.

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 (2)

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