Obesity, AdolescentCIMTNCT06152068
Insulin Resistance, Lipid Profile, CRP, IL-18 and Carotid Intima-Media Thickness (CIMT) Diameter in Obese Adolescents
An observational study of Obesity, Adolescent, run by Universitas Airlangga at 1 site in Indonesia.
Trial summary
Carotid intima-media thickness (CIMT) is a marker for detecting endothelium dysfunction, and has become a non-invasive method that is very useful in detecting and evaluating subclinical atherosclerosis in obese children and adolescents. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Adolescent
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2023to 30 Apr 2024
- How long will I take part?
- 6 Months
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy adolescents
Who may be able to join
- Adolescents (obese and normal)
- Aged 13-18 years old
- Not Smoking
- Not consumed alcohol and drugs
Who cannot join
- Suffering from infections, inflammation, autoimmune diseases, cancer, chronic diseases, and endocrine disorders
- consuming steroids or hormone therapy
Trial locations and contacts
1 site in 1 country.
About this study
Carotid intima-media thickness (CIMT) is a marker for detecting endothelium dysfunction, and has become a non-invasive method that is very useful in detecting and evaluating subclinical atherosclerosis in obese children and adolescents. This method is very useful in visually detecting and monitoring changes in the intima and its medial thickness, and can also evaluate changes within the arterial wall in the absence of localized plaque. Previous research that was conducted found an increase in CIMT diameter in 44 of 59 obese adolescents. Obesity has a risk of increasing the diameter of CIMT which carries the risk of atherosclerosis. Obesity accompanied by insulin resistance, and metabolic syndrome has a greater risk of atherosclerosis. Currently, the prevalence of obesity in adolescents is increasing. Interleukin 18 is a group of interleukin 1 whose levels increase in chronic inflammatory processes such as obesity, metabolic syndrome, and type 2 diabetes mellitus. IL-18 levels increase in obesity with increased CIMT.
Assessment of cardiovascular risk in obese adolescents is still a challenge for health practitioners, to prevent cardiovascular complications in obese adolescents which can cause sudden death at a young age. It is necessary to assess changes in the cardiovascular system that can be identified early by knowing the CIMT diameter. However, there is no definite reference value so the CIMT can be used as a reference for the occurrence of subclinical atherosclerosis in obese adolescents. In the previous study, CIMT was not examined in non-obese adolescents, so the cut-off for CIMT in non-obese was not known. Therefore, we have the opportunity to research to determine the thickness of CIMT and determine the cut-off value of CIMT which is at risk of experiencing early atherosclerosis in the obese adolescent population.
Read the detailed description
This research is a cross-sectional study with an analytical observational to examine Carotid Intima-Media Thickness (CIMT) in normal adolescents compared to obese adolescents. The research population was obese adolescents aged 13-18 years who study in Junior and Senior High School in Surabaya and Sidoarjo. The samples were research subjects, namely obese teenagers who met the inclusion criteria and exclusion criteria. The selection of research samples was carried out randomly. The number of research samples was based on previous research with adolescent subjects, obtaining a minimum sample size of 50.
- Conditions
- Obesity, Adolescent
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obesity | Subjects with obesity were assessed with body mass index or BMI (calculated with body weight in kg divided by body height square in m). The subjects were determined to be obese if BMI value z-score > +2 SD of WHO child growth standard (assessed with WHO Anthroplus). | |
| non-obesity | Subjects non-obesity were assessed with body mass index or BMI (calculated with body weight in kg divided by body height square in m). The subjects were determined to be non-obesity if BMI value z-score < +2 SD of WHO child growth standard (assessed with WHO Anthroplus). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
The data will be presented as mean +/- SD (standard deviation). The body weight will be measure with Seca electronic flat scale 813, in kg.
(in grams) for subjects >24 months age.
Measured: 5 months
Body height
The data will be presented as mean +/- SD (standard deviation). The body height was measured using stadiometer Seca 213 (in cm).
Measured: 5 months
Body Mass Index (BMI)
BMI was calculated by dividing body weight (in kg) by body height square (in m) [body weight (kg)/body height2 (m2)], in kg/m2 unit. The data will be presented as mean +/- standard deviation (SD)
Measured: 5 months
Blood pressure
blood pressure was measure using Omron Automatic Blood Pressure Monitor (Omron Health Care Co., Ltd, Japan) (in mmHg), by placing the cuff on the right arm, then pull and tighten it according to the size if the arm. After it was installed correctly (fasten and did not move), the power button on the digital tension tool was pressed, and then the microprocessor started to drive air pressure into the cuff, and then the value of blood pressures will appear in the manometer tube column. Systolic blood pressure measurement was performed in a sitting position after the subject had rested for 10 minutes. The data will be presented as mean +/- standard deviation (SD)
Measured: 5 months
Fasting insulin
Blood samples were collected at 08.00-09.00 after the subject fasted for 12 hours through the median cubital vein. Ten ml of blood was taken. The blood sample collection was done by a laboratory's employers or a nurse who had been hired by the researchers. After the blood was taken, it was placed into a tube containing ethylenediaminetetraacetic acid (EDTA) for further analysis of Fasting insulin (FI). After that, the tube containing blood samples was placed in a cooling box for transport to the lab. The data will be presented as mean +/- SD, in μU/mL.
Measured: 5 months
Secondary outcomes (1)
Carotid Intima Media Thickness
A CIMT test uses ultrasound technology to create images of your artery layers.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Oct 2023
- Primary completion31 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AdolescentStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universitas Airlangga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andy Darma, MD, Universitas Airlangga
- Investigators
- Nur Aisiyah Widjaja, Ph.D, Principal investigator, Child Health Department, Faculty of Medicine, Universitas Airlangga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152068
- Sponsor's protocol ID
- Forth ID
- Acronym
- CIMT
- Status last verified
- May 2024
- First submitted
- 21 Nov 2023
- Last updated
- 3 Jun 2024
- 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 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance, Lipid Profile, CRP, IL-18 and Carotid Intima-Media Thickness (CIMT) Diameter in Obese Adolescents
- ClinicalTrials.gov ID
- NCT06152068
- Acronym / sponsor ID
- CIMT / Forth ID
- Conditions
- Obesity, Adolescent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitas AirlanggaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 30 Nov 2023 (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.
Carotid intima-media thickness (CIMT) is a marker for detecting endothelium dysfunction, and has become a non-invasive method that is very useful in detecting and evaluating subclinical atherosclerosis in obese children and adolescents. This method is very useful in visually detecting and monitoring changes in the intima and its medial thickness, and can also evaluate changes within the arterial wall in the absence of localized plaque. Previous research that was conducted found an increase in CIMT diameter in 44 of 59 obese adolescents. Obesity has a risk of increasing the diameter of CIMT which carries the risk of atherosclerosis. Obesity accompanied by insulin resistance, and metabolic syndrome has a greater risk of atherosclerosis. Currently, the prevalence of obesity in adolescents is increasing. Interleukin 18 is a group of interleukin 1 whose levels increase in chronic inflammatory processes such as obesity, metabolic syndrome, and type 2 diabetes mellitus. IL-18 levels increase in obesity with increased CIMT.
Assessment of cardiovascular risk in obese adolescents is still a challenge for health practitioners, to prevent cardiovascular complications in obese adolescents which can cause sudden death at a young age. It is necessary to assess changes in the cardiovascular system that can be identified early by knowing the CIMT diameter. However, there is no definite reference value so the CIMT can be used as a reference for the occurrence of subclinical atherosclerosis in obese adolescents. In the previous study, CIMT was not examined in non-obese adolescents, so the cut-off for CIMT in non-obese was not known. Therefore, we have the opportunity to research to determine the thickness of CIMT and determine the cut-off value of CIMT which is at risk of experiencing early atherosclerosis in the obese adolescent population.
Detailed description
This research is a cross-sectional study with an analytical observational to examine Carotid Intima-Media Thickness (CIMT) in normal adolescents compared to obese adolescents. The research population was obese adolescents aged 13-18 years who study in Junior and Senior High School in Surabaya and Sidoarjo. The samples were research subjects, namely obese teenagers who met the inclusion criteria and exclusion criteria. The selection of research samples was carried out randomly. The number of research samples was based on previous research with adolescent subjects, obtaining a minimum sample size of 50.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity | – | –Subjects with obesity were assessed with body mass index or BMI (calculated with body weight in kg divided by body height square in m). The subjects were determined to be obese if BMI value z-score > +2 SD of WHO child growth standard (assessed with WHO Anthroplus). |
| non-obesity | – | –Subjects non-obesity were assessed with body mass index or BMI (calculated with body weight in kg divided by body height square in m). The subjects were determined to be non-obesity if BMI value z-score < +2 SD of WHO child growth standard (assessed with WHO Anthroplus). |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy adolescents
Key inclusion criteria (4 listed)
- Adolescents (obese and normal)
- Aged 13-18 years old
- Not Smoking
- Not consumed alcohol and drugs
Key exclusion criteria (2 listed)
- Suffering from infections, inflammation, autoimmune diseases, cancer, chronic diseases, and endocrine disorders
- consuming steroids or hormone therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body weight
Time frame: 5 months
The data will be presented as mean +/- SD (standard deviation). The body weight will be measure with Seca electronic flat scale 813, in kg. (in grams) for subjects >24 months age.
Body height
Time frame: 5 months
The data will be presented as mean +/- SD (standard deviation). The body height was measured using stadiometer Seca 213 (in cm).
Body Mass Index (BMI)
Time frame: 5 months
BMI was calculated by dividing body weight (in kg) by body height square (in m) [body weight (kg)/body height2 (m2)], in kg/m2 unit. The data will be presented as mean +/- standard deviation (SD)
Blood pressure
Time frame: 5 months
blood pressure was measure using Omron Automatic Blood Pressure Monitor (Omron Health Care Co., Ltd, Japan) (in mmHg), by placing the cuff on the right arm, then pull and tighten it according to the size if the arm. After it was installed correctly (fasten and did not move), the power button on the digital tension tool was pressed, and then the microprocessor started to drive air pressure into the cuff, and then the value of blood pressures will appear in the manometer tube column. Systolic blood pressure measurement was performed in a sitting position after the subject had rested for 10 minutes. The data will be presented as mean +/- standard deviation (SD)
Fasting insulin
Time frame: 5 months
Blood samples were collected at 08.00-09.00 after the subject fasted for 12 hours through the median cubital vein. Ten ml of blood was taken. The blood sample collection was done by a laboratory's employers or a nurse who had been hired by the researchers. After the blood was taken, it was placed into a tube containing ethylenediaminetetraacetic acid (EDTA) for further analysis of Fasting insulin (FI). After that, the tube containing blood samples was placed in a cooling box for transport to the lab. The data will be presented as mean +/- SD, in μU/mL.
1 secondary outcome
Carotid Intima Media Thickness
Time frame: 5 months
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 3 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Obesity, Adolescent
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
Improving Sleep Health and Circadian Timing to Support Cardiometabolic Health in Adolescents
Overweight Adolescents, Sleep
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.
Nur Aisiyah Widjaja, Ph.D principal investigator
Child Health Department, Faculty of Medicine, Universitas Airlangga
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, Adolescent, run by Universitas Airlangga at 1 site in Indonesia.
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 4 inclusion and 2 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 3 Jun 2024. 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 Indonesia. 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?
Body weight (time frame: 5 months). The study lists 5 primary outcomes in all. 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 3 Jun 2024.