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ObesitysICAM-1NCT05951894

Flow-mediated Arterial Dilatation, Hypertension, Endothelin-1 and sICAM-1 in Obese Adolescents

An observational study of Obesity and Hypertension, 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
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Hypertension, Adolescent Obesity
How many people
70 participants
Where
1 siteIndonesia
Study dates
1 Aug 2023to 31 Oct 2023
How long will I take part?
5 Months
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: Obese adolescents aged 13-18 years old

Who may be able to join

  • Obesity
  • Healthy
  • Study in Junior or Senior High School in Surabaja city

Who cannot join

  • Smoking or consuming alcohol
  • Suffering from infections, inflammation, autoimmune diseases, cancer, chronic diseases, and endocrine disorders
  • consuming steroids or hormone therapy

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • RS Bhayangkara Surabaya

    Surabaya, East Java, 61318

Other trials in Indonesia

About this study

Official title: Flow-mediated Arterial Dilatation, Hypertension, Endothelin-1 (ET-1) and Soluble Intercellular Adhesion Molecule (sICAM-1) in Obese Adolescents

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.

Read the 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.

Keywords
Obesity, Flow-mediated Arterial Dilatation, Hypertension, sICAM-1
Medical subject headings
Obesity, Hypertension, Pediatric Obesity

What participants receive

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

Study groups in NCT05951894
Study groupRoleWhat they receive
HypertensionThis group consists of obese adolescents with hypertension, defined as systole blood pressure >130 mmHg or diastole blood pressure >85 mmHg, or both
Non-hypertensionThis group consists of obese adolescents without hypertension
Normal (non-obese)This group consist of normal subjects (non-obese)

What is being measured

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

  1. Body height

    Body height will be measured using Seca 213 stadiometer. The subjects were asked to step at the stadiometer base in an upright state, with the heel, the buttock, and the shoulder blade touching the scale pool. The chin up, look straight ahead. The head slider was lowered until it touches the cranium. Noted the body height in the data collection sheet (presenting in mean +/- SD, in cm). The subject must use light clothes without accessories or footwear, such as hats or hair ponytail.

    Measured: 5 months

  2. Body weight

    Body weight will be measured using Tanita RD 953-BK digital scale (presenting in mean +/- SD, in kg). The subjects were asked to step at the scale in an upright state. The body weight appears on the screen and is then noted in the data collection sheet. The subject must use light clothes without accessories or footwear

    Measured: 5 months

  3. Hip circumference (HC)

    Hip circumference will be measured using Seca 201 measuring tape (in cm), by asking the subjects to keep the feet together, then wrapping the measuring tape around the widest part of the hips, at the point of the greatest gluteal protuberance. The subjects were measured using light cloth without food wear and other accessories such as belts, hats, hair accessories, etc. The data will be presented as mean +/- SD

    Measured: 5 months

  4. Waist circumference (WC)

    Waist circumference will be measured using Seca 201 measuring tape (in cm), 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. The subjects were measured using light cloth without food wear and other accessories such as belts, hats, hair accessories, etc. The data will be presented as mean +/- standard deviation (SD)

    Measured: 5 months

  5. Flow-mediated Arterial Dilatation diameter

    FMD was calculated as the maximum percentage increase in diameter of the brachial artery after ischemia of the forearm. The measurements were performed in supine position at the elbow of the right arm. The cuff was placed on the forearm, distally to the measurement site. The duration of ischemia of the forearm was 5 min. All lumen diameter measurements were done at end diastole by the use of the R-wave of the electrocardiogram. The ultrasound images were made by one technician with a 7.5 megahertz (MHz) linear array transducer of an Ultramark duplex scanner. All images were stored on flash-disk for off-line analysis. Measurement of the endothelium-independent vasodilatation using nitroglycerine, was not performed.

    Measured: 5 months

  6. Endothelin-1

    Endothelin-1 will be analyzed using the Human Endothelin-1 Elisa kit (Bioassay Technology Laboratory) (in ng/ml). The data will be presented as mean +/- standard deviation (SD)

    Measured: 5 months

  7. sICAM-1

    sICAM-1 will be analyzed using Human intercellular adhesion molecule 1 Elisa kit (Bioassay Technology Laboratory) (in ng/ml). The data will be presented as mean +/- standard deviation (SD)

    Measured: 5 months

Secondary outcomes (9)

  1. Body Mass Index (BMI)

    BMI was calculated by dividing body weight (in kg) by body height square (in m) [body weight (kg)/body height2 (m2)], in kg/m2 unit. The data will be presented as mean +/- standard deviation (SD)

    Measured: 5 months

  2. Systolic blood pressure

    Systolic blood pressure was measure using Omron Automatic Blood Pressure Monitor (Omron Health Care Co., Ltd, Japan) (in mmHg), 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. Systolic blood pressure measurement was performed in a sitting position after the subject had rested for 10 minutes. The data will be presented as mean +/- standard deviation (SD)

    Measured: 5 months

  3. Diastolic blood pressure

    Diastolic blood pressure was measure using Omron Automatic Blood Pressure Monitor (Omron Health Care Co., Ltd, Japan) (in mmHg), 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. Diastolic blood pressure measurement was performed in a sitting position after the subject had rested for 10 minutes. The data will be presented as mean +/- standard deviation (SD)

    Measured: 5 months

  4. Fasting blood glucose

    Blood samples were collected at 08.00-09.00 after the subject fasted for 12 hours through the median cubital vein. Ten ml of blood was taken. The blood sample collection was done by a laboratory's employers or a nurse who had been hired by the researchers. After the blood was taken, it was placed into a tube containing ethylenediaminetetraacetic acid (EDTA) for further analysis of fasting blood glucose (FBG). After that, the tube containing blood samples was placed in a cooling box for transport to the lab. The data will be presented as mean +/- SD, in mg/dL.

    Measured: 5 months

  5. Total cholesterol

    Blood samples were collected at 08.00-09.00 after the subject fasted for 12 hours through the median cubital vein. Ten ml of blood was taken. The blood sample collection was done by a laboratory's employers or a nurse who had been hired by the researchers. After the blood was taken, it was placed into a tube containing ethylenediaminetetraacetic acid (EDTA) for further analysis of Total cholesterol. After that, the tube containing blood samples was placed in a cooling box for transport to the lab. The data will be presented as mean +/- SD, in mg/dL.

    Measured: 5 months

  6. HDL-c

    Blood samples were collected at 08.00-09.00 after the subject fasted for 12 hours through the median cubital vein. Ten ml of blood was taken. The blood sample collection was done by a laboratory's employers or a nurse who had been hired by the researchers. After the blood was taken, it was placed into a tube containing ethylenediaminetetraacetic acid (EDTA) for further analysis of High-density lipoprotein cholesterol (HDL-c). After that, the tube containing blood samples was placed in a cooling box for transport to the lab. The data will be presented as mean +/- SD, in mg/dL.

    Measured: 5 months

  7. LDL-c

    Blood samples were collected at 08.00-09.00 after the subject fasted for 12 hours through the median cubital vein. Ten ml of blood was taken. The blood sample collection was done by a laboratory's employers or a nurse who had been hired by the researchers. After the blood was taken, it was placed into a tube containing ethylenediaminetetraacetic acid (EDTA) for further analysis of Low-density lipoprotein cholesterol (LDL-c). After that, the tube containing blood samples was placed in a cooling box for transport to the lab. The data will be presented as mean +/- SD, in mg/dL.

    Measured: 5 months

  8. Triglyceride

    Blood samples were collected at 08.00-09.00 after the subject fasted for 12 hours through the median cubital vein. Ten ml of blood was taken. The blood sample collection was done by a laboratory's employers or a nurse who had been hired by the researchers. After the blood was taken, it was placed into a tube containing ethylenediaminetetraacetic acid (EDTA) for further analysis of Triglycerides After that, the tube containing blood samples was placed in a cooling box for transport to the lab. The data will be presented as mean +/- SD, in mg/dL.

    Measured: 5 months

  9. Fasting insulin

    Blood samples were collected at 08.00-09.00 after the subject fasted for 12 hours through the median cubital vein. Ten ml of blood was taken. The blood sample collection was done by a laboratory's employers or a nurse who had been hired by the researchers. After the blood was taken, it was placed into a tube containing ethylenediaminetetraacetic acid (EDTA) for further analysis of Fasting insulin (FI). After that, the tube containing blood samples was placed in a cooling box for transport to the lab. The data will be presented as mean +/- SD, in μU/mL.

    Measured: 5 months

Timeline

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

  1. First posted19 Jul 2023
  2. Study start1 Aug 2023
  3. Primary completion31 Oct 2023
  4. Study completion31 Oct 2023

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
Case-control
Time perspective
Cross-sectional
Enrolment
70 participants (actual)
Target duration
5 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05951894
Sponsor's protocol ID
A Number
Other IDs
UA number
Acronym
sICAM-1
Status last verified
Nov 2023
First submitted
19 Jun 2023
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhao W, Mo L, Pang Y. Hypertension in adolescents: The role of obesity and family history. J Clin Hypertens (Greenwich). 2021 Dec;23(12):2065-2070. doi: 10.1111/jch.14381. Epub 2021 Nov 16.

    PubMed 34783422

  • Koenen M, Hill MA, Cohen P, Sowers JR. Obesity, Adipose Tissue and Vascular Dysfunction. Circ Res. 2021 Apr 2;128(7):951-968. doi: 10.1161/CIRCRESAHA.121.318093. Epub 2021 Apr 1.

    PubMed 33793327

  • Bellamkonda K, Williams M, Handa A, Lee R. Flow Mediated Dilatation as a Biomarker in Vascular Surgery Research. J Atheroscler Thromb. 2017 Aug 1;24(8):779-787. doi: 10.5551/jat.40964. Epub 2017 Jul 1.

    PubMed 28674324

  • Weissgerber TL. Flow-mediated dilation: can new approaches provide greater mechanistic insight into vascular dysfunction in preeclampsia and other diseases? Curr Hypertens Rep. 2014 Nov;16(11):487. doi: 10.1007/s11906-014-0487-z.

    PubMed 25182159

  • Green DJ, Jones H, Thijssen D, Cable NT, Atkinson G. Flow-mediated dilation and cardiovascular event prediction: does nitric oxide matter? Hypertension. 2011 Mar;57(3):363-9. doi: 10.1161/HYPERTENSIONAHA.110.167015. Epub 2011 Jan 24.

    PubMed 21263128

  • Maruhashi T, Kajikawa M, Kishimoto S, Hashimoto H, Takaeko Y, Yamaji T, Harada T, Han Y, Aibara Y, Mohamad Yusoff F, Hidaka T, Kihara Y, Chayama K, Nakashima A, Goto C, Tomiyama H, Takase B, Kohro T, Suzuki T, Ishizu T, Ueda S, Yamazaki T, Furumoto T, Kario K, Inoue T, Koba S, Watanabe K, Takemoto Y, Hano T, Sata M, Ishibashi Y, Node K, Maemura K, Ohya Y, Furukawa T, Ito H, Ikeda H, Yamashina A, Higashi Y. Diagnostic Criteria of Flow-Mediated Vasodilation for Normal Endothelial Function and Nitroglycerin-Induced Vasodilation for Normal Vascular Smooth Muscle Function of the Brachial Artery. J Am Heart Assoc. 2020 Jan 21;9(2):e013915. doi: 10.1161/JAHA.119.013915. Epub 2020 Jan 8.

    PubMed 31910779

  • Jenkins HN, Rivera-Gonzalez O, Gibert Y, Speed JS. Endothelin-1 in the pathophysiology of obesity and insulin resistance. Obes Rev. 2020 Dec;21(12):e13086. doi: 10.1111/obr.13086. Epub 2020 Jul 6.

    PubMed 32627269

  • Yang L, Magnussen CG, Yang L, Bovet P, Xi B. Elevated Blood Pressure in Childhood or Adolescence and Cardiovascular Outcomes in Adulthood: A Systematic Review. Hypertension. 2020 Apr;75(4):948-955. doi: 10.1161/HYPERTENSIONAHA.119.14168. Epub 2020 Mar 2.

    PubMed 32114851

  • Dulskiene V, Kuciene R, Medzioniene J, Benetis R. Association between obesity and high blood pressure among Lithuanian adolescents: a cross-sectional study. Ital J Pediatr. 2014 Dec 10;40:102. doi: 10.1186/s13052-014-0102-6.

    PubMed 25492217

  • Widjaja NA, Irawan R, Prihaningtyas RA, Ardiana M, Hanindita MH. Carotid intima-media thickness, hypertension, and dyslipidemia in obese adolescents. Pan Afr Med J. 2019 Nov 7;34:134. doi: 10.11604/pamj.2019.34.134.18309. eCollection 2019.

    PubMed 33708303

  • Rundek T, Gardener H, Della-Morte D, Dong C, Cabral D, Tiozzo E, Roberts E, Crisby M, Cheung K, Demmer R, Elkind MS, Sacco RL, Desvarieux M. The relationship between carotid intima-media thickness and carotid plaque in the Northern Manhattan Study. Atherosclerosis. 2015 Aug;241(2):364-70. doi: 10.1016/j.atherosclerosis.2015.05.027. Epub 2015 Jun 3.

    PubMed 26071659

  • Rivera-Gonzalez O, Wilson NA, Coats LE, Taylor EB, Speed JS. Endothelin receptor antagonism improves glucose handling, dyslipidemia, and adipose tissue inflammation in obese mice. Clin Sci (Lond). 2021 Jul 30;135(14):1773-1789. doi: 10.1042/CS20210549.

    PubMed 34278410

  • Busjahn A, Knoblauch H, Knoblauch M, Bohlender J, Menz M, Faulhaber HD, Becker A, Schuster H, Luft FC. Angiotensin-converting enzyme and angiotensinogen gene polymorphisms, plasma levels, cardiac dimensions. A twin study. Hypertension. 1997 Jan;29(1 Pt 2):165-70. doi: 10.1161/01.hyp.29.1.165.

    PubMed 9039097

  • Giannini C, de Giorgis T, Scarinci A, Cataldo I, Marcovecchio ML, Chiarelli F, Mohn A. Increased carotid intima-media thickness in pre-pubertal children with constitutional leanness and severe obesity: the speculative role of insulin sensitivity, oxidant status, and chronic inflammation. Eur J Endocrinol. 2009 Jul;161(1):73-80. doi: 10.1530/EJE-09-0042. Epub 2009 May 7.

    PubMed 19423560

  • Witte DR, Broekmans WM, Kardinaal AF, Klopping-Ketelaars IA, van Poppel G, Bots ML, Kluft C, Princen JM. Soluble intercellular adhesion molecule 1 and flow-mediated dilatation are related to the estimated risk of coronary heart disease independently from each other. Atherosclerosis. 2003 Sep;170(1):147-53. doi: 10.1016/s0021-9150(03)00253-3.

    PubMed 12957693

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Hypertension, 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 3 inclusion and 3 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 21 Nov 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?

Body height (time frame: 5 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05951894, which also lists 17 linked publications.

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 21 Nov 2023.

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