NCT05685017

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 1, 2023

Last Update Submit

January 6, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

    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)

    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)

    4 months

Secondary Outcomes (2)

  • Physical Measurements: Body weight

    4 months

  • Physical Measurements: Body height

    4 months

Other Outcomes (7)

  • Physical Measurements: Waist Circumference

    4 months

  • Physical Measurements: Hip Circumference

    4 months

  • Blood Pressure: Systole and diastole

    4 months

  • +4 more other outcomes

Study Arms (1)

Metablic syndrome vs. non-metabolic syndrome

Obese adolescents were grouped on MetS vs. non-MetS based on The International Diabetic Federation criteria

Diagnostic Test: Nur Aisiyah Widjaja

Interventions

Nur Aisiyah WidjajaDIAGNOSTIC_TEST

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

Also known as: Suhasta Nova, Leonardo Alexander Caesar
Metablic syndrome vs. non-metabolic syndrome

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Obesity
  • Healthy (no medication treatment)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Surabaya, East Java, 60286, Indonesia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples were withdrawn via vena cubitus as much as 5 ml by the trained analyst, and placed on vacutainer with EDTA. After that, the vacutainer was replaced in icebox to transport to the laboratory. Blood analysis including: 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).

MeSH Terms

Conditions

ObesityObesity, AbdominalMetabolic SyndromeHypertensionHypertriglyceridemiaHypoalphalipoproteinemiasHyperglycemia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesVascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersHypolipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Andy Darma, Paediatrician

    Child Health Departement Airlangga University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator on Gastroenterology

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 13, 2023

Study Start

October 1, 2019

Primary Completion

January 30, 2020

Study Completion

June 30, 2020

Last Updated

January 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations