Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05685017 |
| Other study ID # |
Secondary ID |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2019 |
| Est. completion date |
June 30, 2020 |
Study information
| Verified date |
January 2023 |
| Source |
Universitas Airlangga |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Adipose tissue secreting a number of adipokines which regulate insulin sensitivity, energy
metabolism and vascular homeostasis, so the dysfunction of adipose tissue is linked with the
incidence of obesity accompanied with insulin resistance, hypertension and cardiovascular
disease (1). Obesity is known to alters the expression of adipokines due to the adipose
tissue hypertrophy (2), including adiponectin, in which able to exert a potent
anti-inflammatory and vascular protective effect (2).
It has been proposed that adiponectin acts to prevent the vascular dysfunction due to obesity
and diabetes by improves insulin sensitivity and metabolic profiles to reduce the risk
factors for cardiovascular disease and protects the vasculature through its pleiotropic
actions on endothelial cells, endothelial progenitor cells, smooth muscle cells and
macrophages (1). The concentrations of adiponectin of 5 to 25 mg/mL had a significant
inhibitory effect on the expression of monocyte adhesion and adhesion molecule induced by
TNF-α in vitro. Atherosclerosis is an inflammatory disease in which adhesion molecules on
arterial endothelial cells are responsible for the accumulation of monocytes/macrophages and
T lymphocytes. While obesity is low-grade inflammation in which make a contribution on
endothelial dysfunction by increasing the oxygen-derived free radicals (ROS) due to adipocyte
hypertrophy, leads to an endoplasmic reticulum (ER) stress and mitochondrial dysfunction (3).
Adiponectin is accumulated in the vasculature, and it reduced on obesity due to suppression
by TNF-α and lead to adiponectin-deficiency which stimulate the significant increases of
Vascular cell adhesion protein 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1) or
known as CD54 in aortic intima (4).
Here we investigate the level of adiponectin, ICAM-1, VCAM-1 with the incidence of MetS in
obese adolescents.
Description:
A cross sectional study with healthy obese adolescents aged 13 until 18 years old were
conducted during October 2019 to January 2020. Obesity was determined based on body mass
index (BMI) for age based on gender > percentile 95th of CDC growth chart 2000.
Body weight was measured using Seca Robusta 813 digital scale in standing position, by
stepping on the scale. While Body height was measured using Seca 206 Body Meter. Height was
measured from the vertex of the head to the heel in standing position. Waist circumference
and hip circumference were measured using Seca 201 measuring tape. Waist circumference was
measured by wrapping the measuring tape around the subject's stomach, at the midpoint between
the lowest rib and the endpoint of the iliac crest upon expiration, in line with the navel.
Hip circumference was measured by asking the subjects to keep the feet together, then
wrapping the measuring tape around the widest part of hips, at the point of the greatest
gluteal protuberance. The subjects were measured using light cloth without food wear and
other accessories such as belt, hat, or hair accessories, etc.
Blood pressure was measure using Omron Automatic Blood Pressure Monitor HEM-8712 (Omron
Health Care Co., Ltd, Japan) 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.
Metabolic syndrome criteria were determined using The International Diabetic Federation
criteria18:
1. For adolescent aged 10-16 years old: if there was a central obesity (waist circumference
> 90th percentile based on WHO waist circumference table. For boys at the circumference
of > 88 cm, and ≥ 85 cm for girls) accompanied with at least 2 other signs below:
- Blood pressure > 90th percentile (systole ≥130/diastole ≥ 85 mmHg).
- Hypertriglyceridemia, if the triglyceride levels > 110 mg/dl.
- Low level HDL-c, if the HDL-c levels < 40 mg/dl, and < 50 mg/dl for girls.
- Hyperglycaemia, if fasting blood glucose (FBG) levels was > 110 mg/dl.
2. For adolescent aged more than 16 years old: if there was a central obesity (waist
circumference > 90th percentile based on WHO waist circumference table. For boys at the
circumference of > 94 cm, and ≥ 80 cm for girls) accompanied with at least 2 other signs
below:
- Blood pressure > 90th percentile (systole ≥130/diastole ≥ 85 mmHg).
- Hypertriglyceridemia, if the triglyceride levels ≥ 150 mg/dl.
- Low level HDL-c, if the HDL-c levels <40 mg/dl for boys, and < 50 mg/dl for girls.
- Hyperglycaemia, if fasting blood glucose (FBG) levels was ≥ 100 mg/dl19. Blood
samples were withdrawn via vena cubitus as much as 5 ml by the trained analysts,
and placed on vacutainer with EDTA. After that, the vacutainer was replaced in
icebox to transport to the laboratory. Blood analysis include: lipid profile,
fasting blood glucose, fasting insulin and adiponectin using the ELISA method in
the laboratory. Intercellular Adhesion Molecule-1 (ICAM-1) was analyzed using Human
intercellular adhesion molecule 1 Elisa kit (Bioassay Technology Laboratory). while
sVCAM-1 was analysed using Human vascular cell adhesion molecule-1 Elisa kit
(Bioassay Technology Laboratory).
Statistical analysis conducted were test of normality and homogeneity test, Anova/
Kruskal-Wallis, Independent sample T-test/Mann-Whitney U test, and Spearman correlation, and
determined as significant if p value<0.05.
