Insulin Resistance, Lipid Profile, CRP, IL-18 and Carotid Intima-Media Thickness (CIMT) Diameter in Obese Adolescents

NCT ID: NCT06152068

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-04-30

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.

Conditions

Obesity, Adolescent

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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).

No interventions assigned to this group

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).

No interventions assigned to this group

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitas Airlangga

OTHER

Sponsor Role: lead

Responsible Party

Andy Darma, MD

Principal Investigator and Medical Staf in Pediatric Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nur Aisiyah Widjaja, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Child Health Department, Faculty of Medicine, Universitas Airlangga

Locations

RS Bhayangkara Surabaya

Surabaya, East Java, Indonesia

Countries

Indonesia

Other Identifiers

Forth ID

Identifier Type: -

Identifier Source: org_study_id