Cord Blood Preptin Levels in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2025-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Phoenixin-14 Levels in Term Babies

NCT06656481

Diabetes, Gestational Weight, Fetal

COMPLETED

Vaspin Levels Compared With Serum Insulin and Blood Glucose Levels in Neonates

NCT01363622

Insulin Sensitivity

UNKNOWN

Serum Vasohibin, Cardiotrophin, Endocan & Perinatal Outcomes

NCT06416995

Preeclampsia Gestational Hypertension Gestational Diabetes +2 more

RECRUITING

Cord Blood S100B Protein Concentration in Neonates With Fetal Growth Restriction

NCT06893926

s100b Hypoxia-Ischemia, Brain Fetal Growth Restriction (FGR)

RECRUITING

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

NCT06891586

Newborn Morbidity Newborn Complication

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

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. In the investigator's study, preptin levels will be examined in infants of diabetic mothers, infants with high birth weight from healthy mothers, normal birth weight infants, and infants with low birth weight for their gestational age.

No invasive procedures or additional blood sampling will be performed on the patients for the study. The blood samples used will be obtained from residual umbilical cord blood collected for routine tests such as blood gas analysis and blood typing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Newborn Morbidity Newborn Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.