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.
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
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:
- 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.
- 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.
- Conditions
- Obesity, Abdominal Obesity, Metabolic Syndrome, Hypertension, Hypertriglyceridemia, HDL Cholesterol, Low Serum
- 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 group | Role | What they receive |
|---|---|---|
| Metablic syndrome vs. non-metabolic syndrome | Obese 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.
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
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
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)
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
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.
- First posted13 Jan 2023
- Study start1 Oct 2019
- Primary completion30 Jan 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Universitas Airlangga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andy Darma, MD, Universitas Airlangga
- Investigators
- Andy Darma, Paediatrician, Principal investigator, Child Health Departement Airlangga University
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiponectin, ICAM-1, VCAM-1 Levels and Metabolic Syndrome in Obese Adolescents
- ClinicalTrials.gov ID
- NCT05685017
- Acronym / sponsor ID
- ICAM; VCAM / Secondary ID
- Conditions
- Obesity, Abdominal Obesity, Metabolic Syndrome, Hypertension, Hypertriglyceridemia, HDL Cholesterol, Low Serum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Universitas AirlanggaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metablic syndrome vs. non-metabolic syndrome | – | Diagnostic Test: Nur Aisiyah WidjajaObese adolescents were grouped on MetS vs. non-MetS based on The International Diabetic Federation criteria |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- Obesity
- Healthy (no medication treatment)
Key exclusion criteria (5 listed)
- Taking corticosteroids or dyslipidemia medication
- Smoking or drinking (consuming alcohol)
- Taking antibiotics or hormonal therapy
- Autoimmune disease
- Endocrinology disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nur Aisiyah WidjajaAlso: Suhasta Nova, Leonardo Alexander CaesarBlood analysis for ICAM-1, VCAM-1, blood fasting insulin, lipid profile, fasting blood glucose and adiponectin investigation | Diagnostic test | Metablic syndrome vs. non-metabolic syndrome |
Primary outcome
ICAM-1 levels
Time frame: 4 months
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)
VCAM-1
Time frame: 4 months
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)
Adiponectin
Time frame: 4 months
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)
2 secondary outcomes
Physical Measurements: Body weight
Time frame: 4 months
Physical Measurements: Body height
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andy Darma, Paediatrician principal investigator
Child Health Departement Airlangga University
1 site in 1 country: see every site and its status.
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.