Clinical trial NCT06775990: Molecules Associated with Pediatric Obesity
Official title: The Evaluation of Current Molecules and Receptor Profiles Associated with Pediatric Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: OBESITY
Keywords: Child
Obesity
Obesity parameters and receptors
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Scientific Research Project Coordination Unit of Istanbul University-Cerrahpasa
First posted: 2025-01-15
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.

Detailed description: 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.

Before the study, Ethics Committee approval documents numbered 2020.01.01.01 were obtained from Tekirdağ Namık Kemal University where the study was conducted. The families of the children, especially their parents, were informed. After a detailed pediatric physical examination and informing them about their inclusion in the study, signed consent forms from the consenting parents were obtained, and the children were informed verbally. Peripheral blood samples obtained from the children were collected, centrifuged, and stored in the biochemistry laboratory in deep freezers at -80°C.

The weights, heights, and waist, hip, head, and neck circumferences (Cs) of all the children were measured and recorded. BMI, waist/hip ratios, and other ratios and formulas related to obesity were calculated from anthropometric measurements, and statistical analyses of the anthropometric measurements of controls and children with obesity were performed.

NLRP3, leptin, acylated ghrelin, deacyl ghrelin, preptin, PPAR γ, LEPR, GHSR, KISS1R, and IL-18 were analyzed by the sandwich ELISA method, and ghrelin and KISS1 parameters were analyzed by the competitive ELISA method in the control and obese groups.

In the statistical evaluation of the data, parametric or nonparametric statistical tests appropriate for the distribution characteristics of the data obtained were applied. The Shapiro-Wilk test was used to determine whether the values of the parameters conformed to a normal distribution. Independent samples t tests, Mann-Whitney U tests, and Kruskal-Wallis tests were used to evaluate the differences between the groups, and Pearson and Spearman correlation analyses were performed to examine whether the values of the parameters changed together. In addition, the Mann-Whitney U test was applied with the Bonferroni correction in the evaluation of subgroups.

Statistical analyses were performed with SPSS (Statistical Package for the Social Sciences) Version 26. The means, standard deviations, standard errors, and medians were compared between the control and obese groups. The statistically significant difference between them was evaluated according to whether the values showed a parametric or nonparametric distribution. P values less than 0.05 were considered significant.

Eligibility criteria: Inclusion Criteria:

* Children aged 6-18 years were included in the study
* 30 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Obesity BMI values according to WHO criteria accepted by the Ministry of Health
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Teki̇rdağ
country: Turkey
facility: Namik Kemal University
Study officials:
affiliation: Istanbul Beykent University
name: Ezgi Kürkçü Kahraman, Assist Prof.
role: PRINCIPAL_INVESTIGATOR
References: