NCT06775990

Brief Summary

Childhood obesity is linked to obesity in adulthood and causes severe problems, particularly due to its relationship with metabolic syndrome, diabetes, cancer, and cardiovascular diseases. The determination of markers and receptor profiles related to parameters contributing to energy homeostasis in healthy children with a normal body mass index and children with obesity will guide the diagnosis and treatment of pediatric obesity. The aim was to determine possible relationships by evaluating markers contributing to energy homeostasis in healthy individuals and children with obesity. Anthropometric measurements of the children were obtained. The serum leptin, leptin receptor (LEPR), ghrelin, acylated ghrelin, deacylated ghrelin, ghrelin receptor (GHSR), kisspeptin (KISS1), kisspeptin receptor (KISS1R), preptin, peroxisome proliferator activated receptor gamma (PPARγ), nod-like receptor pyrin domain-containing 3 (NLRP3), and interleukin-18 (IL-18) levels of thirty children with obesity and thirty healthy children were determined using ELISA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

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

June 4, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

January 4, 2025

Last Update Submit

January 15, 2025

Conditions

Keywords

ChildObesityObesity parameters and receptors

Outcome Measures

Primary Outcomes (1)

  • Obesity BMI values according to WHO criteria accepted by the Ministry of Health

    Two groups were formed from 30 children with obesity BMI values above the 95th percentile according to the WHO criteria accepted by the Ministry of Health and 30 children with healthy BMI values between the 85th and 15th percentiles who constituted the control group. Weight in kilograms Height in meters weight and height will be combined to report BMI in kg/m\^2

    6 months

Study Arms (2)

Healthy control

Children between the ages of 06-18 years without acute or chronic diseases and without major congenital anomalies were included in the study. Two groups were formed from 30 obese children with BMI values above the 95th percentile according to the WHO criteria accepted by the Ministry of Health and 60 healthy children with BMI values between the 85th and 15th percentiles who constituted the control group. Of the 60 children, 35 were girls and 25 were boys. Serum leptin, leptin receptor (LEPR), ghrelin, acylated ghrelin, deacylated ghrelin, ghrelin receptor (GHSR), kisspeptin (KISS1), kisspeptin receptor (KISS1R), preptin, Peroxisome proliferator-activated receptor gamma (PPAR γ), nod-like receptor pyrin domain-containing 3 (NLRP3), interleukin-18 (IL-18) levels were determined by ELISA in thirty obese and thirty healthy children.

Other: Blood sample

Obese children.

Children between the ages of 06-18 years without acute or chronic diseases and without major congenital anomalies were included in the study. Two groups were formed from 30 obese children with BMI values above the 95th percentile according to the WHO criteria accepted by the Ministry of Health and 60 healthy children with BMI values between the 85th and 15th percentiles who constituted the control group. Of the 60 children, 35 were girls and 25 were boys. Serum leptin, leptin receptor (LEPR), ghrelin, acylated ghrelin, deacylated ghrelin, ghrelin receptor (GHSR), kisspeptin (KISS1), kisspeptin receptor (KISS1R), preptin, Peroxisome proliferator-activated receptor gamma (PPAR γ), nod-like receptor pyrin domain-containing 3 (NLRP3), interleukin-18 (IL-18) levels were determined by ELISA in thirty obese and thirty healthy children.

Other: Blood sample

Interventions

Children were not given any medication in the study. Peripheral blood samples from the children were collected, centrifuged and stored in the biochemistry laboratory in deep freezers at -80 degree celcius. From stored serum samples leptin, leptin receptor (LEPR), ghrelin, acylated ghrelin, deacylated ghrelin, ghrelin receptor (GHSR), kisspeptin (KISS1), kisspeptin receptor (KISS1R), preptin, Peroxisome proliferator-activated receptor gamma (PPAR γ), nod-like receptor pyrin domain-containing 3 (NLRP3), interleukin-18 (IL-18) levels were determined by ELISA in thirty obese and thirty healthy children.

Healthy controlObese children.

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children between the ages of 6 and 18 years without acute or chronic diseases and without major congenital anomalies were included in the study. Peripheral blood samples were collected from children admitted to Tekirdağ Namık Kemal University Faculty of Medicine, Department of Pediatrics after 8-12 hours of fasting. Two groups were formed from 30 children with obesity BMI values above the 95th percentile according to the WHO criteria accepted by the Ministry of Health and 30 children with healthy BMI values between the 85th and 15th percentiles who constituted the control group. Of the 60 children, 35 were girls and 25 were boys.

You may qualify if:

  • Children aged 6-18 years were included in the study
  • obese children with BMI values above the 95th percentile according to WHO criteria and 30 healthy children with BMI values between the 85th and 15th percentiles and 60 healthy children with anorexia were included in the study
  • Children without acute or chronic diseases and without major congenital anomalies were included in the study.

You may not qualify if:

  • Be over 18 years of age
  • Presence of conditions that may cause secondary obesity, such as hypothyroidism or polycystic ovary syndrome
  • Children with previous bariatric surgery or repeated diet attempts;
  • Children with a serious acute or chronic illness (active infection, heart failure, cardiovascular disease, cerebrovascular disease, acute renal failure, chronic renal failure, chronic lung disease, malignancy) were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Namik Kemal University

Tekirdağ, Tekirdağ, 59010, Turkey (Türkiye)

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples were stored at -80 degrees Celsius.

MeSH Terms

Conditions

Obesity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ezgi Kürkçü Kahraman, Assist Prof.

    Istanbul Beykent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof.

Study Record Dates

First Submitted

January 4, 2025

First Posted

January 15, 2025

Study Start

June 4, 2020

Primary Completion

September 6, 2021

Study Completion

June 8, 2022

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations