Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656481
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-19
Brief Title:
Comparison of Phoenixin-14 Levels in Term Babies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
COMPARISON OF PHOENIXIN-14 LEVELS IN UMBILICAL CORD BLOOD ACCORDING TO BIRTH WEIGHT IN TERM INFANTS ARE PHOENIXIN-14 LEVELS LINKED TO BIRTH WEIGHT AND MATERNAL DIABETES
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PNX-14
Brief Summary:
INTRODUCTION Birth weight and pregnancy week are determinants of mortality and morbidity of newborn infants Birth weights by gestational week are associated with accompanying diseases in the later stages of life 1 Infants with a birth weight below the 10th percentile by gestational week are defined as small for gestational age SGA those with a birth weight above the 90th percentile are defined as large for gestational age LGA and those with a birth weight between the 10th and 90th percentiles are defined as appropriate for gestational age AGA 2 In LGA and SGA infants problems such as hypoglycemia hypoxia polycythemia and respiratory support may be encountered in the neonatal period These infants may also experience diseases that affect the quality and duration of life at later ages such as metabolic syndrome obesity cardiovascular diseases and diabetes mellitus 1 2 Gestational diabetes mellitus GDM is the most common complication during pregnancy and is defined as any degree of glucose intolerance that begins or is first recognized during pregnancy 3 GDM has long been associated with obstetric and neonatal complications particularly those related to high birth weight and is increasingly recognized as a risk factor for future cardiometabolic disease in the child As the causes of serious health problems can be attributed to maternal illness or changes in birth weight these issues continue to be investigated 4
Phoenixin PNX is a neuropeptide first described by Yosten et al in 2013 5 The most common isoforms of PNX phoenixin-14 PNX-14 and phoenixin-20 PNX-20 exhibit similar biological activities and are peptides composed of 14 and 20 amino acids respectively 5 In the initial characterization of PNX it was reported to be crucial for normal reproductive function through its effects on the hypothalamus-pituitary-gonadal axis The literature provides further evidence for the role of PNX in reproductive functions and suggests that it also plays a role in other aspects of brain-mediated and peripheral physiology In addition there is some evidence demonstrating that PNX affects the heart diet memory and anxiety 6 Animal studies of PNX-14 have shown that PNX-14 has an important role in the central control of feeding behavior and metabolic homeostasis In addition to correlations between PNX-14 and body mass index BMI studies have shown that PNX-14 modulates food intake and feeding behavior 7 PNX-14 is a neuropeptide known to prevent oxidative damage and stimulate insulin secretion Animal studies have shown that PNX-14 treatments prevent pancreatic damage and β-cell loss by reducing oxidative stress 8 A study indicating that PNX-14 plays an important role in the occurrence of diabetes and obesity found that PNX-14 concentrations were significantly lower in patients with type 2 diabetes mellitus than in healthy individuals 9 10
In this study we investigated the relationships between normal AGA low SGA and high LGA birth weight according to gestational week of pregnancy and phoenixin-14 levels in the umbilical cord blood of healthy infants of healthy mothers and infants of mothers diagnosed with GDM regardless of birth weight
Phoenixin PNX is a neuropeptide first described by Yosten et al in 2013 5 The most common isoforms of PNX phoenixin-14 PNX-14 and phoenixin-20 PNX-20 exhibit similar biological activities and are peptides composed of 14 and 20 amino acids respectively 5 In the initial characterization of PNX it was reported to be crucial for normal reproductive function through its effects on the hypothalamus-pituitary-gonadal axis The literature provides further evidence for the role of PNX in reproductive functions and suggests that it also plays a role in other aspects of brain-mediated and peripheral physiology In addition there is some evidence demonstrating that PNX affects the heart diet memory and anxiety 6 Animal studies of PNX-14 have shown that PNX-14 has an important role in the central control of feeding behavior and metabolic homeostasis In addition to correlations between PNX-14 and body mass index BMI studies have shown that PNX-14 modulates food intake and feeding behavior 7 PNX-14 is a neuropeptide known to prevent oxidative damage and stimulate insulin secretion Animal studies have shown that PNX-14 treatments prevent pancreatic damage and β-cell loss by reducing oxidative stress 8 A study indicating that PNX-14 plays an important role in the occurrence of diabetes and obesity found that PNX-14 concentrations were significantly lower in patients with type 2 diabetes mellitus than in healthy individuals 9 10
In this study we investigated the relationships between normal AGA low SGA and high LGA birth weight according to gestational week of pregnancy and phoenixin-14 levels in the umbilical cord blood of healthy infants of healthy mothers and infants of mothers diagnosed with GDM regardless of birth weight
Detailed Description:
INTRODUCTION Birth weight and pregnancy week are determinants of mortality and morbidity of newborn infants Birth weights by gestational week are associated with accompanying diseases in the later stages of life 1 Infants with a birth weight below the 10th percentile by gestational week are defined as small for gestational age SGA those with a birth weight above the 90th percentile are defined as large for gestational age LGA and those with a birth weight between the 10th and 90th percentiles are defined as appropriate for gestational age AGA 2 In LGA and SGA infants problems such as hypoglycemia hypoxia polycythemia and respiratory support may be encountered in the neonatal period These infants may also experience diseases that affect the quality and duration of life at later ages such as metabolic syndrome obesity cardiovascular diseases and diabetes mellitus 1 2 Gestational diabetes mellitus GDM is the most common complication during pregnancy and is defined as any degree of glucose intolerance that begins or is first recognized during pregnancy 3 GDM has long been associated with obstetric and neonatal complications particularly those related to high birth weight and is increasingly recognized as a risk factor for future cardiometabolic disease in the child As the causes of serious health problems can be attributed to maternal illness or changes in birth weight these issues continue to be investigated 4
Phoenixin PNX is a neuropeptide first described by Yosten et al in 2013 5 The most common isoforms of PNX phoenixin-14 PNX-14 and phoenixin-20 PNX-20 exhibit similar biological activities and are peptides composed of 14 and 20 amino acids respectively 5 In the initial characterization of PNX it was reported to be crucial for normal reproductive function through its effects on the hypothalamus-pituitary-gonadal axis The literature provides further evidence for the role of PNX in reproductive functions and suggests that it also plays a role in other aspects of brain-mediated and peripheral physiology In addition there is some evidence demonstrating that PNX affects the heart diet memory and anxiety 6 Animal studies of PNX-14 have shown that PNX-14 has an important role in the central control of feeding behavior and metabolic homeostasis In addition to correlations between PNX-14 and body mass index BMI studies have shown that PNX-14 modulates food intake and feeding behavior 7 PNX-14 is a neuropeptide known to prevent oxidative damage and stimulate insulin secretion Animal studies have shown that PNX-14 treatments prevent pancreatic damage and β-cell loss by reducing oxidative stress 8 A study indicating that PNX-14 plays an important role in the occurrence of diabetes and obesity found that PNX-14 concentrations were significantly lower in patients with type 2 diabetes mellitus than in healthy individuals 9 10
In this study we investigated the relationships between normal AGA low SGA and high LGA birth weight according to gestational week of pregnancy and phoenixin-14 levels in the umbilical cord blood of healthy infants of healthy mothers and infants of mothers diagnosed with GDM regardless of birth weight
MATERIALS AND METHODS We obtained approval for this prospective study from the Karatay University Ethics Committee Ethics Committee Decision No 2022005 and Konya City Hospital We conducted the research between December 2022 and April 2024 at Konya City Hospital in the Department of Obstetrics and Gynecology the Neonatal Intensive Care Unit and the Department of Medical Biochemistry Clinical Trials ID NCT
Patients Infants with multiple congenital anomalies chorioamnionitis and preeclampsia infants who were born after premature rupture of membranes infants who needed intensive care and otherwise ill or premature infants were excluded from the study Infants whose mothers had any disease other than diabetes were also excluded Healthy term infants born between 3707 and 4267 weeks born by spontaneous vaginal delivery or cesarean section were included in the study The demographic and neonatal data and the PNX-14 levels of the patients included in the study were recorded
The sample size was determined with two-way independent-samples t-test power analysis based on previous studies According to previous similar studies phoenixin-14 ratios with an error margin of 005 actual power level of 09554213 and effect size of 141 would require a minimum of 24 deliveries 12 vaginal deliveries and 12 cesarean sections for each pairwise comparison however aiming to reduce the margin of error we planned to include 40 infants in each group Four different groups were considered in this study
1 Infants with low birth weight by gestational week SGA Of the 42 infants in this group whose mothers agreed to participate in the study 2 were excluded due to incomplete laboratory data or hospitalization in the neonatal intensive care unit due to sepsis and 40 SGA infants 20 born by spontaneous vaginal delivery and 20 by cesarean delivery were included in the study
2 Infants with normal birth weight by gestational week AGA Of the 47 infants in this group 7 were excluded due to incomplete laboratory data or mothers declining to participate and 40 AGA infants 20 born by spontaneous vaginal delivery and 20 by cesarean delivery were included in the study
3 Infants with high birth weight by gestational week LGA Of the 44 babies in this group whose mothers agreed to participate in the study 4 were excluded due to suspected sepsis incomplete laboratory data or neonatal intensive care unit hospitalization and 40 LGA infants 20 born by spontaneous vaginal delivery and 20 by cesarean delivery were included in the study
4 Infants whose mothers had gestational diabetes mellitus GDM Of the 41 infants in this group whose mothers agreed to participate in the study 1 was excluded due to missing antenatal demographic data and 40 infants 4 born by spontaneous vaginal delivery and 36 by cesarean delivery were included in the study
Biochemical analysis After obtaining informed consent from their parents umbilical cord blood samples were collected from all infants The obtained blood samples were centrifuged within 6 hours and the serum was separated Following the manufacturers instructions commercial kits BT Lab Bioassay Technology Laboratory Human ELISA Kits Shanghai Korain Biotech Shanghai China were used to perform enzyme immunoassay analyses of serum PNX-14 levels Using an ELx800 Absorbance Microplate Reader Biotech Winooski VT USA the absorbance was measured at 450 nm The concentration values for PNX-14 were expressed in ngL The kits sensitivity was 819 ngL and the standard curve range was 20-3800 ngL Interassay and intraassay differences were less than 10 and 8 respectively
Phoenixin PNX is a neuropeptide first described by Yosten et al in 2013 5 The most common isoforms of PNX phoenixin-14 PNX-14 and phoenixin-20 PNX-20 exhibit similar biological activities and are peptides composed of 14 and 20 amino acids respectively 5 In the initial characterization of PNX it was reported to be crucial for normal reproductive function through its effects on the hypothalamus-pituitary-gonadal axis The literature provides further evidence for the role of PNX in reproductive functions and suggests that it also plays a role in other aspects of brain-mediated and peripheral physiology In addition there is some evidence demonstrating that PNX affects the heart diet memory and anxiety 6 Animal studies of PNX-14 have shown that PNX-14 has an important role in the central control of feeding behavior and metabolic homeostasis In addition to correlations between PNX-14 and body mass index BMI studies have shown that PNX-14 modulates food intake and feeding behavior 7 PNX-14 is a neuropeptide known to prevent oxidative damage and stimulate insulin secretion Animal studies have shown that PNX-14 treatments prevent pancreatic damage and β-cell loss by reducing oxidative stress 8 A study indicating that PNX-14 plays an important role in the occurrence of diabetes and obesity found that PNX-14 concentrations were significantly lower in patients with type 2 diabetes mellitus than in healthy individuals 9 10
In this study we investigated the relationships between normal AGA low SGA and high LGA birth weight according to gestational week of pregnancy and phoenixin-14 levels in the umbilical cord blood of healthy infants of healthy mothers and infants of mothers diagnosed with GDM regardless of birth weight
MATERIALS AND METHODS We obtained approval for this prospective study from the Karatay University Ethics Committee Ethics Committee Decision No 2022005 and Konya City Hospital We conducted the research between December 2022 and April 2024 at Konya City Hospital in the Department of Obstetrics and Gynecology the Neonatal Intensive Care Unit and the Department of Medical Biochemistry Clinical Trials ID NCT
Patients Infants with multiple congenital anomalies chorioamnionitis and preeclampsia infants who were born after premature rupture of membranes infants who needed intensive care and otherwise ill or premature infants were excluded from the study Infants whose mothers had any disease other than diabetes were also excluded Healthy term infants born between 3707 and 4267 weeks born by spontaneous vaginal delivery or cesarean section were included in the study The demographic and neonatal data and the PNX-14 levels of the patients included in the study were recorded
The sample size was determined with two-way independent-samples t-test power analysis based on previous studies According to previous similar studies phoenixin-14 ratios with an error margin of 005 actual power level of 09554213 and effect size of 141 would require a minimum of 24 deliveries 12 vaginal deliveries and 12 cesarean sections for each pairwise comparison however aiming to reduce the margin of error we planned to include 40 infants in each group Four different groups were considered in this study
1 Infants with low birth weight by gestational week SGA Of the 42 infants in this group whose mothers agreed to participate in the study 2 were excluded due to incomplete laboratory data or hospitalization in the neonatal intensive care unit due to sepsis and 40 SGA infants 20 born by spontaneous vaginal delivery and 20 by cesarean delivery were included in the study
2 Infants with normal birth weight by gestational week AGA Of the 47 infants in this group 7 were excluded due to incomplete laboratory data or mothers declining to participate and 40 AGA infants 20 born by spontaneous vaginal delivery and 20 by cesarean delivery were included in the study
3 Infants with high birth weight by gestational week LGA Of the 44 babies in this group whose mothers agreed to participate in the study 4 were excluded due to suspected sepsis incomplete laboratory data or neonatal intensive care unit hospitalization and 40 LGA infants 20 born by spontaneous vaginal delivery and 20 by cesarean delivery were included in the study
4 Infants whose mothers had gestational diabetes mellitus GDM Of the 41 infants in this group whose mothers agreed to participate in the study 1 was excluded due to missing antenatal demographic data and 40 infants 4 born by spontaneous vaginal delivery and 36 by cesarean delivery were included in the study
Biochemical analysis After obtaining informed consent from their parents umbilical cord blood samples were collected from all infants The obtained blood samples were centrifuged within 6 hours and the serum was separated Following the manufacturers instructions commercial kits BT Lab Bioassay Technology Laboratory Human ELISA Kits Shanghai Korain Biotech Shanghai China were used to perform enzyme immunoassay analyses of serum PNX-14 levels Using an ELx800 Absorbance Microplate Reader Biotech Winooski VT USA the absorbance was measured at 450 nm The concentration values for PNX-14 were expressed in ngL The kits sensitivity was 819 ngL and the standard curve range was 20-3800 ngL Interassay and intraassay differences were less than 10 and 8 respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None