- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06775990
Molecules Associated with Pediatric Obesity (Thesis)
The Evaluation of Current Molecules and Receptor Profiles Associated with Pediatric Obesity
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.
Study Overview
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Teki̇rdağ, Turkey, 59010
- Namik Kemal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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. |
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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Obesity BMI values according to WHO criteria accepted by the Ministry of Health
Time Frame: 6 months
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ezgi Kürkçü Kahraman, Assist Prof., Istanbul Beykent University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 34574 (Other Grant/Funding Number: Istanbul University-Cerrahpasa)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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