Cord Blood Alarin Levels in Term Babies

March 28, 2024 updated by: Melek Buyukeren, Konya City Hospital

Comparison of Cord Blood Alarin Levels in Term Babies According to Birth Weight

In this study, alarin levels in the cord blood of babies with large birth weights will be compared with babies of normal weight. Thus, the investigators aimed to find out whether there is a relationship between babies' birth weights and alarin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Studies have shown that the galanin neuropeptide family plays a role in regulating appetite, insulin resistance, obesity, hypertension and metabolism. Alarin is a peptide consisting of 25 amino acids. Current research shows that allerin plays an important role in the emergence and development of diabetes and obesity. There are studies that found that the serum alarin level increased significantly in patients with impaired glucose tolerance and type 2 diabetes mellitus. Additionally, studies have found that both non-obese and obese type 2 diabetes mellitus serum alarin levels increase.

Studies in the literature are related to adults, and there are no studies on alarin levels in newborn babies.

Based on the alarin studies available in the literature, the investigators determined whether there is a relationship between the alarin level and the baby's birth weight by comparing the alarin level in the cord blood of babies with a high birth weight according to their gestational age (both babies of diabetic mothers and babies of non-diabetic mothers) compared to babies whose birth weight is within the normal range. the investigators aimed to find it.

Study Type

Observational

Enrollment (Actual)

87

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 Locations

  • Turkey
    • Sıhhiye
      • Konya, Sıhhiye, Turkey, 06100
        • MELEK

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

No

Sampling Method

Non-Probability Sample

Study Population

Babies born between the planned dates and whose families gave consent for the study were divided into four different groups according to their characteristics:

  1. Babies with normal weight according to gestational age (AGA): 25 babies were included in the study.
  2. Low weight babies for gestational age (SGA): 20 babies were included in the study.
  3. Large-weight babies for gestational age (LGA): 22 babies were included in the study.
  4. Babies whose mothers had gestational diabetes mellitus: 20 babies were included in the study.

Description

Inclusion Criteria:

  • Babies given consent by their families
  • Healthy babies

Exclusion Criteria:

  • Babies with syndromic appearance or any accompanying disease
  • Babies whose family does not give consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Appropriate for gestational age
Diagnostic test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM
No intervention
small for gestational age
Diagnostic test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM
No intervention
large for gestational age
Diagnostic test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM
No intervention
Baby of mother diagnosed with GDM
Baby of mother diagnosed with gestational diabetes mellitus
Diagnostic test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of cord blood alarin levels of babies in different groups according to birth weight (low-appropriate-large) and babies of mothers diagnosed with gestational diabetes regardless of birth weight.
Time Frame: postnatal 5 minutes
umbilical cord blood alarin levels
postnatal 5 minutes

Collaborators and Investigators

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

Sponsor

Konya City Hospital

Investigators

  • Study Director: 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 18, 2023

Primary Completion (Actual)

December 23, 2023

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSH_MB_2024_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol, Statistical Analysis Plan and Clinical Study Report

IPD Sharing Time Frame

6 months after the article was published

IPD Sharing Access Criteria

The data set generated and analyzed in this study are available from corresponding author on a reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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.

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