NCT06333548

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 20, 2024

Last Update Submit

March 28, 2024

Conditions

Keywords

NEWBORNALARİNUMBİLİCAL CORD BLOOD

Outcome Measures

Primary Outcomes (1)

  • 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.

    umbilical cord blood alarin levels

    postnatal 5 minutes

Study Arms (4)

Appropriate for gestational age

Appropriate for gestational age

Diagnostic Test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM

small for gestational age

small for gestational age

Diagnostic Test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM

large for gestational age

large for gestational age

Diagnostic Test: Appropriate for gestational age , small for gestational age, large for gestational age, Baby of mother diagnosed with GDM

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

Interventions

No intervention

Appropriate for gestational ageBaby of mother diagnosed with GDMlarge for gestational agesmall for gestational age

Eligibility Criteria

Age1 Minute - 5 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Babies given consent by their families
  • Healthy babies

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MELEK

Konya, Sıhhiye, 06100, Turkey (Türkiye)

Location

Related Publications (2)

  • Zhou X, Luo M, Zhou S, Cheng Z, Chen Z, Yu X. Plasma Alarin Level and Its Influencing Factors in Obese Newly Diagnosed Type 2 Diabetes Patients. Diabetes Metab Syndr Obes. 2021 Jan 27;14:379-385. doi: 10.2147/DMSO.S290072. eCollection 2021.

  • Hu W, Fan X, Zhou B, Li L, Tian B, Fang X, Xu X, Liu H, Yang G, Liu Y. Circulating alarin concentrations are high in patients with type 2 diabetes and increased by glucagon-like peptide-1 receptor agonist treatment: An Consort-compliant study. Medicine (Baltimore). 2019 Jul;98(28):e16428. doi: 10.1097/MD.0000000000016428.

MeSH Terms

Conditions

Birth Weight

Interventions

Gestational Age

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fetal DevelopmentEmbryonic and Fetal DevelopmentMorphogenesisGrowth and DevelopmentPhysiological PhenomenaReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • MELEK BUYUKEREN

    Konya City Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 20, 2024

First Posted

March 27, 2024

Study Start

September 18, 2023

Primary Completion

December 23, 2023

Study Completion

January 15, 2024

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Study Protocol, Statistical Analysis Plan and Clinical Study Report

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
6 months after the article was published
Access Criteria
The data set generated and analyzed in this study are available from corresponding author on a reasonable request.

Locations