OBESITYThesisNCT06775990
Molecules Associated with Pediatric Obesity
An observational study of OBESITY, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- OBESITY
- What is being tested?
- Blood sample
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jun 2020to 8 Jun 2022
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Namik Kemal University
Tekirdağ, Tekirdağ, 59010
About this study
Official title: 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.
Read the 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.
- Conditions
- OBESITY
- Being tested
- Blood sample
- Keywords
- Child, Obesity, Obesity parameters and receptors
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start4 Jun 2020
- Primary completion6 Sep 2021
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OBESITYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Scientific Research Project Coordination Unit of Istanbul University-Cerrahpasa
- Responsible party
- Principal investigator, Ezgi Kürkçü Kahraman, Istanbul University - Cerrahpasa
- Investigators
- Ezgi Kürkçü Kahraman, Assist Prof., Principal investigator, Istanbul Beykent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775990
- Sponsor's protocol ID
- 34574
- Other IDs
- 34574
- Acronym
- Thesis
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Current Molecules and Receptor Profiles Associated with Pediatric Obesity
- ClinicalTrials.gov ID
- NCT06775990
- Acronym / sponsor ID
- Thesis / 34574
- Conditions
- OBESITY
- Keywords
- Child, Obesity, Obesity parameters and receptors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Scientific Research Project Coordination Unit of Istanbul University-Cerrahpasa
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | Other: Blood sampleChildren 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. |
| Obese children. | – | Other: Blood sampleChildren 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleChildren 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. | Other | Healthy control, Obese children. |
Primary outcome
Obesity BMI values according to WHO criteria accepted by the Ministry of Health
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- NIH Case Reports Metabolism . 2021 Mar:116:154438. doi: 10.1016/j.metabol.2020.154438. Epub 2020 Nov 19.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezgi Kürkçü Kahraman, Assist Prof. principal investigator
Istanbul Beykent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OBESITY, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obesity BMI values according to WHO criteria accepted by the Ministry of Health (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.