AzTrials
AzTrials

ObesityICAM; VCAMNCT05685017

Adiponectin, ICAM-1, VCAM-1 Levels and Metabolic Syndrome in Obese Adolescents

An observational study of Obesity and Abdominal Obesity, run by Universitas Airlangga at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 13 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Abdominal Obesity, Metabolic Syndrome
What is being tested?
Nur Aisiyah Widjaja
How many people
125 participants
Where
1 siteIndonesia
Study dates
1 Oct 2019to 30 Jun 2020
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Study population: The subjects were obese adolescents who were studied at Junior and Senior High School in Surabaya and Sidoarjo, East Java, Indonesia

Who may be able to join

  • Obesity
  • Healthy (no medication treatment)

Who cannot join

  • Taking corticosteroids or dyslipidemia medication
  • Smoking or drinking (consuming alcohol)
  • Taking antibiotics or hormonal therapy
  • Autoimmune disease
  • Endocrinology disorders

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Institute of Tropical Disease (ITD) Airlangga University, Campus C

    Surabaya, East Java, 60286

Other trials in Indonesia

About this study

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.

Read the detailed 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.
  1. 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.

Being tested
Nur Aisiyah Widjaja
Medical subject headings
Obesity, Obesity, Abdominal, Metabolic Syndrome, Hypertension, Hypertriglyceridemia, Hypoalphalipoproteinemias, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nur Aisiyah WidjajaDiagnostic test

    Also called Suhasta Nova, Leonardo Alexander Caesar

    Blood analysis for ICAM-1, VCAM-1, blood fasting insulin, lipid profile, fasting blood glucose and adiponectin investigation

Study groups in NCT05685017
Study groupRoleWhat they receive
Metablic syndrome vs. non-metabolic syndromeObese adolescents were grouped on MetS vs. non-MetS based on The International Diabetic Federation criteria
Receives: Diagnostic Test: Nur Aisiyah Widjaja

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ICAM-1 levels

    Intercellular Adhesion Molecule 1 also known as CD54 was measured Human intercellular adhesion molecule 1 Elisa kit (Bioassay Technology Laboratory), stated as pg/ml (mean +/- SD)

    Measured: 4 months

  2. VCAM-1

    Vascular cell adhesion molecule 1 was measured using Human vascular cell adhesion molecule-1 Elisa kit (Bioassay Technology Laboratory), stated as pg/ml (mean +/- SD)

    Measured: 4 months

  3. Adiponectin

    For Adiponectin, ICAM-1 and VCAM-1 analysis, the blood that has been taken was not immediately analysed. The blood was centrifuged to remove the serum, and then stored at -70°C until the analysis was performed in the laboratory. Adiponectin was analysed using using Human Adiponectin Elisa kit (Bioassay Technology Laboratory), stated as ng/ml (mean +/- SD)

    Measured: 4 months

Secondary outcomes (2)
  1. Physical Measurements: Body weight

    body weight was measured using Seca Robusta 813 digital scale in standing position by stepping on the scale. The subjects were asked to use light clothes without footwear or accessories. Stated as kg (mean +/- SD)

    Measured: 4 months

  2. Physical Measurements: Body height

    Body height was measured using Seca 206 Body Meter. Height was measured from the vertex of the head to the heel in standing position without footwear or accessories such as hat

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2023
  2. Study start1 Oct 2019
  3. Primary completion30 Jan 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
125 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT05685017
Sponsor's protocol ID
Secondary ID
Acronym
ICAM; VCAM
Status last verified
Jan 2023
First submitted
1 Jan 2023
Last updated
13 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Abdominal Obesity, run by Universitas Airlangga at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICAM-1 levels (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in