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NCT06152068Completed

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

Source: ClinicalTrials.gov · Last updated 3 Jun 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
50 (actual)
First submitted
21 Nov 2023
Start date
1 Oct 2023
Primary completion date
31 Mar 2024
Lead sponsor
Universitas Airlangga
Diseases
Obesity
NCT number
NCT06152068

What you commit to

  • Study type: Observational
  • Participants enrolled: 50
  • From 1 Oct 2023 to the primary completion date, 31 Mar 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • consuming steroids or hormone therapy

Other illness

  • Suffering from infections, inflammation, autoimmune diseases, cancer, chronic diseases, and endocrine disorders

Who the study is looking for

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

Age in the registry: 13 years to 18 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
RS Bhayangkara Surabaya
Coordinator of this site? Confirm its status
SurabayaIndonesiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.