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

NCT ID: NCT05951894

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2023-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Hypertension Adolescent Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hypertension

This group consists of obese adolescents with hypertension, defined as systole blood pressure \>130 mmHg or diastole blood pressure \>85 mmHg, or both

No interventions assigned to this group

Non-hypertension

This group consists of obese adolescents without hypertension

No interventions assigned to this group

Normal (non-obese)

This group consist of normal subjects (non-obese)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Smoking or consuming alcohol
* Suffering from infections, inflammation, autoimmune diseases, cancer, chronic diseases, and endocrine disorders
* consuming steroids or hormone therapy
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitas Airlangga

OTHER

Sponsor Role lead

Responsible Party

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Nur Aisiyah Widjaja

Principal Investigator on Nutrition and Metabolic Disease

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Budi Santoso, Professor

Role: STUDY_CHAIR

Universitas Airlangga

Achmad Tri Ludfy Avianto, MD

Role: STUDY_CHAIR

Universitas Airlangga

Locations

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RS Bhayangkara Surabaya

Surabaya, East Java, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 34783422 (View on PubMed)

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.

Reference Type RESULT
PMID: 33793327 (View on PubMed)

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.

Reference Type RESULT
PMID: 28674324 (View on PubMed)

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.

Reference Type RESULT
PMID: 25182159 (View on PubMed)

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.

Reference Type RESULT
PMID: 21263128 (View on PubMed)

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.

Reference Type RESULT
PMID: 31910779 (View on PubMed)

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.

Reference Type RESULT
PMID: 32627269 (View on PubMed)

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.

Reference Type RESULT
PMID: 32114851 (View on PubMed)

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.

Reference Type RESULT
PMID: 25492217 (View on PubMed)

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.

Reference Type RESULT
PMID: 33708303 (View on PubMed)

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.

Reference Type RESULT
PMID: 26071659 (View on PubMed)

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.

Reference Type RESULT
PMID: 34278410 (View on PubMed)

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.

Reference Type RESULT
PMID: 9039097 (View on PubMed)

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.

Reference Type RESULT
PMID: 19423560 (View on PubMed)

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.

Reference Type RESULT
PMID: 12957693 (View on PubMed)

Dzikowska-Diduch O, Domienik-Karlowicz J, Gorska E, Demkow U, Pruszczyk P, Kostrubiec M. E-selectin and sICAM-1, biomarkers of endothelial function, predict recurrence of venous thromboembolism. Thromb Res. 2017 Sep;157:173-180. doi: 10.1016/j.thromres.2017.07.027. Epub 2017 Jul 26.

Reference Type RESULT
PMID: 28780342 (View on PubMed)

Glowinska B, Urban M, Peczynska J, Florys B. Soluble adhesion molecules (sICAM-1, sVCAM-1) and selectins (sE selectin, sP selectin, sL selectin) levels in children and adolescents with obesity, hypertension, and diabetes. Metabolism. 2005 Aug;54(8):1020-6. doi: 10.1016/j.metabol.2005.03.004.

Reference Type RESULT
PMID: 16092051 (View on PubMed)

Other Identifiers

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UA number

Identifier Type: OTHER

Identifier Source: secondary_id

A Number

Identifier Type: -

Identifier Source: org_study_id