Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT05951894
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2023-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flow-mediated Arterial Dilatation, Hypertension, Endothelin-1 and sICAM-1 in Obese Adolescents
Sponsor:
Universitas Airlangga
Organization:
Study Overview
Official Title:
Flow-mediated Arterial Dilatation, Hypertension, Endothelin-1 (ET-1) and Soluble Intercellular Adhesion Molecule (sICAM-1) in Obese Adolescents
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
sICAM-1
Brief Summary:
Obesity in adolescents is associated with the development of cardiovascular disease and type 2 diabetes mellitus. In order to detect early development of cardiovascular disease, early detection of the endothelium of obese adolescents is needed. Endothelium dysfunction is an early stage of developing atherosclerosis, which can be a predictor of cardiovascular disease development in the future. Flow mediated dilatation (FMD) is a non-invasive method that can measure endothelium function and predict the risk of cardiovascular disease, which is not only able to measure artery diameter, but also provides function index of nitric oxide (NO) in the endothelium. FMD is negatively related to BMI. Meanwhile, Endothelin-1 (ET-1) is thought to play a role in the pathogenesis of insulin resistance, because when its levels increase, ET-1 can cause a condition of hyperinsulinemia. ET-1 was found to be high in patients with cardiovascular disorders, as well as in obese and diabetic subjects. Alternative methods for assessing endothelial function by measurement of biomarkers of activation and endothelial dysfunction such as soluble intercellular adhesion molecule-1 (sICAM-1). Levels of sICAM-1 have been found to be related positively to age, systolic and diastolic blood pressure, hypercholesterolemia, hypertriglyceridemia and inversely to estrogen. Furthermore, associations have been found between sICAM-1 and cardiovascular mortality in both healthy individuals and populations at high risk.
The aim of the study was to evaluate FMD, concentrations of ET-1 and sICAM-1 in adolescents with a presence of obesity and hypertension and to compare these with controls (obesity and non hypertension), as well as to analyze the correlations between FMD, ET-1, sICAM-1 and blood pressure values.
The aim of the study was to evaluate FMD, concentrations of ET-1 and sICAM-1 in adolescents with a presence of obesity and hypertension and to compare these with controls (obesity and non hypertension), as well as to analyze the correlations between FMD, ET-1, sICAM-1 and blood pressure values.
Detailed Description:
This study is cross sectional study with observational analytic that evaluates FMD, ET-1 dan sICAM-1 in obese adolescents with hypertension compared to obese adolescents without hypertension and normal adolescents. The subjects are 70 adolescents (obese and normal) aged 13-18 years, healthy, not undergoing any medication, not smoking and not drinking alcohol, which are further divided into 3 groups: obesity with hypertension, obesity without hypertension and normal. Examination includes blood pressure examination, brachial ultrasound and blood sampling to measure levels of profile lipid, blood glucose, ET-1, and sICAM-1. Blood sample of subjects were taken by laboratory employee of the general hospital in Surabaja, Indonesia.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UA number | OTHER | Airlangga University | View |