Clinical trial NCT06152068: Insulin Resistance, Lipid Profile, CRP, IL-18 and Carotid Intima-Media Thickness (CIMT) Diameter in Obese Adolescents
Official title: Insulin Resistance, Lipid Profile, CRP, IL-18 and Carotid Intima-Media Thickness (CIMT) Diameter in Obese Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Adolescent
Lead sponsor: Universitas Airlangga
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adolescents

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Adolescents (obese and normal)
* Aged 13-18 years old
* Not Smoking
* Not consumed alcohol and drugs

Exclusion Criteria:

* Suffering from infections, inflammation, autoimmune diseases, cancer, chronic diseases, and endocrine disorders
* consuming steroids or hormone therapy

Primary outcomes:
measure: Body weight
timeFrame: 5 months
measure: Body height
timeFrame: 5 months
measure: Body Mass Index (BMI)
timeFrame: 5 months
measure: Blood pressure
timeFrame: 5 months
measure: Fasting insulin
timeFrame: 5 months
Secondary outcomes:
measure: Carotid Intima Media Thickness
timeFrame: 5 months
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: RS Bhayangkara Surabaya
state: East Java
Study officials:
affiliation: Child Health Department, Faculty of Medicine, Universitas Airlangga
name: Nur Aisiyah Widjaja, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: