- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06049641
Hypertension in High School Students (HYGEF)
Hypertension in High School Students: Genetic and Environmental Factors
Study Overview
Status
Conditions
Detailed Description
Pediatric hypertension is associated with cardiovascular organ damage, which in turn may lead to cardiovascular disease (CVD) and acute events in adulthood.1 Over the past few decades, the prevalence of hypertension has progressively increased in children and adolescents, generating a significant public health issue and considerable amount of research. BP values among adolescents tend to be less heterogeneous than in adults, and the impact of genetic factors, even if small, may be the expression of pathogenic mechanisms that have been present since birth.
With this study, named HYGEF (Hypertension in high school students: Genetic and Environmental Factors), authors wanted to: 1. determine the prevalence of obesity and hypertension (HT) in a cohort of adolescents, 2. perform genetic analyses to determine a link between specific polymorphisms and/or mutations of genes involved in the development of HT in adults like the Adducin genes and Endogenous Ouabain (EO) and HT and 3. explore whether urine Na+/K+ excretion and urinary markers of inflammation and oxidative stress are linked to HT and cardiovascular risk in participants with the selected genotypes.
Adolescents will be enrolled for the study in high schools in the north (Milan), center (Livorno) and south (Grottaglie) of Italy, to obtain a sample that could be representative of the italian adolescents. During the visit at the high school investigators obtain questionnaires to have some information about eating habits, lifestyle and family history, two (or three in they were very discordant) blood pressure measurements, weight and height of the students, a sample of urine and a sample of saliva to extract DNA.
Genotyping: On the basis of our previous genetic studies carried out in adult patients with hypertension and cardiovascular and renal related diseases, 15 SNPs located in 13 candidate genes have been selected: rs1045642 in ABCB1, rs4343 in ACE (angiotensin converting enzyme), rs4961 in ADD1 (alpha-adducin), rs4984 in ADD2 (beta-adducin), rs3731566 in ADD3 (gamma-adducin), rs11638442 in CYP11A1 (cytochrome P450 family 11 subfamily A member 1), rs1799998 in CYP11B2 (aldosterone synthase), rs2236780, rs6203 and rs10923835 in HSD3B1 genetic region, rs9536314 in KL, rs2254524 in LSS, rs4149601 in neural precursor cell expressed, developmentally down-regulated 4-like, NEDD4L (E3 ubiquitin-protein ligase), PRKG1 (protein kinase, rs1904694 in cGMP-dependent, type I), rs4238595 in UMOD (uromodulin).
Analysis of Urines: Na+, K+, albumin, and creatinine were measured on a first fasting morning urine sample. The Kawasaki formula was used to estimate 24-hour urinary sodium (24h UNa) excretion expressed as mEq/24 h. In a subgroup a urine spot sample for each student will be immediately frozen for protein analysis. Investigators plan to measure simultaneously IL1β, IL6, IL10, IL12p70, TNF-α, MCP1 (monocyte chemoattractant protein), PTX3 (pentraxin-3) by ELISA test using LXSAHM Human Magnetic Luminex Screening Assay. Soluble α- Klotho, 8-Oxo-2'-deoxyguanosine will be measured by Elisa kit assay. Nitric oxide (NO) was measured by the colorimetric Nitric Oxide Assay kit. Advanced Oxidation Protein Products will be measured using the colorimetric OxiSelect Advanced Oxidation Protein Products Assay Kit.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Milan, Italy, 20132
- IRCCS Ospedale San Raffaele
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 13 and 19 years old
- Caucasian
Exclusion Criteria:
- Age more than 19 years old
- Not Caucasian
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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13 to 15 Year-Old
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16 to 19 Year-Old
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The aim of the study was to establish a link of specific polymorphisms of Adducins and EO-related genes with selected phenotypes (hypertension, Na+ and K+ intake).
Time Frame: 2 years
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2 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004 Aug;114(2 Suppl 4th Report):555-76. No abstract available.
- Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, Obarzanek E, Conlin PR, Miller ER 3rd, Simons-Morton DG, Karanja N, Lin PH; DASH-Sodium Collaborative Research Group. Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet. DASH-Sodium Collaborative Research Group. N Engl J Med. 2001 Jan 4;344(1):3-10. doi: 10.1056/NEJM200101043440101.
- Purcell S, Neale B, Todd-Brown K, Thomas L, Ferreira MA, Bender D, Maller J, Sklar P, de Bakker PI, Daly MJ, Sham PC. PLINK: a tool set for whole-genome association and population-based linkage analyses. Am J Hum Genet. 2007 Sep;81(3):559-75. doi: 10.1086/519795. Epub 2007 Jul 25.
- Appel LJ, Brands MW, Daniels SR, Karanja N, Elmer PJ, Sacks FM; American Heart Association. Dietary approaches to prevent and treat hypertension: a scientific statement from the American Heart Association. Hypertension. 2006 Feb;47(2):296-308. doi: 10.1161/01.HYP.0000202568.01167.B6.
- Staessen JA, Wang JG, Brand E, Barlassina C, Birkenhager WH, Herrmann SM, Fagard R, Tizzoni L, Bianchi G. Effects of three candidate genes on prevalence and incidence of hypertension in a Caucasian population. J Hypertens. 2001 Aug;19(8):1349-58. doi: 10.1097/00004872-200108000-00002. Erratum In: J Hypertens 2001 Oct;19(10):1921.
- Intersalt: an international study of electrolyte excretion and blood pressure. Results for 24 hour urinary sodium and potassium excretion. Intersalt Cooperative Research Group. BMJ. 1988 Jul 30;297(6644):319-28. doi: 10.1136/bmj.297.6644.319.
- Polonia J, Lobo MF, Martins L, Pinto F, Nazare J. Estimation of populational 24-h urinary sodium and potassium excretion from spot urine samples: evaluation of four formulas in a large national representative population. J Hypertens. 2017 Mar;35(3):477-486. doi: 10.1097/HJH.0000000000001180.
- Tripodi G, Citterio L, Kouznetsova T, Lanzani C, Florio M, Modica R, Messaggio E, Hamlyn JM, Zagato L, Bianchi G, Staessen JA, Manunta P. Steroid biosynthesis and renal excretion in human essential hypertension: association with blood pressure and endogenous ouabain. Am J Hypertens. 2009 Apr;22(4):357-63. doi: 10.1038/ajh.2009.3. Epub 2009 Feb 5.
- Citterio L, Lanzani C, Manunta P, Bianchi G. Genetics of primary hypertension: the clinical impact of adducin polymorphisms. Biochim Biophys Acta. 2010 Dec;1802(12):1285-98. doi: 10.1016/j.bbadis.2010.03.014. Epub 2010 Apr 8.
- Liu M, Li Y, Citterio L, Huang QF, Zeng WF, Sheng CS, Wei FF, Dong Q, Li GL, Kang YY, Zhang L, Xu TY, Li JJ, Song J, Manunta P, Wang JG. A functional common polymorphism of the ABCB1 gene is associated with chronic kidney disease and hypertension in Chinese. Am J Hypertens. 2013 Dec;26(12):1428-36. doi: 10.1093/ajh/hpt126. Epub 2013 Aug 7.
- de Simone G, Devereux RB, Daniels SR, Koren MJ, Meyer RA, Laragh JH. Effect of growth on variability of left ventricular mass: assessment of allometric signals in adults and children and their capacity to predict cardiovascular risk. J Am Coll Cardiol. 1995 Apr;25(5):1056-62. doi: 10.1016/0735-1097(94)00540-7.
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- Efendiev R, Krmar RT, Ogimoto G, Zwiller J, Tripodi G, Katz AI, Bianchi G, Pedemonte CH, Bertorello AM. Hypertension-linked mutation in the adducin alpha-subunit leads to higher AP2-mu2 phosphorylation and impaired Na+,K+-ATPase trafficking in response to GPCR signals and intracellular sodium. Circ Res. 2004 Nov 26;95(11):1100-8. doi: 10.1161/01.RES.0000149570.20845.89. Epub 2004 Nov 4.
- Manunta P, Maillard M, Tantardini C, Simonini M, Lanzani C, Citterio L, Stella P, Casamassima N, Burnier M, Hamlyn JM, Bianchi G. Relationships among endogenous ouabain, alpha-adducin polymorphisms and renal sodium handling in primary hypertension. J Hypertens. 2008 May;26(5):914-20. doi: 10.1097/HJH.0b013e3282f5315f.
- Ferrari P. Rostafuroxin: an ouabain-inhibitor counteracting specific forms of hypertension. Biochim Biophys Acta. 2010 Dec;1802(12):1254-8. doi: 10.1016/j.bbadis.2010.01.009. Epub 2010 Jan 18.
- Blaustein MP, Chen L, Hamlyn JM, Leenen FH, Lingrel JB, Wier WG, Zhang J. Pivotal role of alpha2 Na+ pumps and their high affinity ouabain binding site in cardiovascular health and disease. J Physiol. 2016 Nov 1;594(21):6079-6103. doi: 10.1113/JP272419. Epub 2016 Jul 31.
- Manunta P, Iacoviello M, Forleo C, Messaggio E, Hamlyn JM, Lucarelli K, Guida P, Romito R, De Tommasi E, Bianchi G, Rizzon P, Pitzalis MV. High circulating levels of endogenous ouabain in the offspring of hypertensive and normotensive individuals. J Hypertens. 2005 Sep;23(9):1677-81. doi: 10.1097/01.hjh.0000177049.38417.67.
- Nzietchueng R, El Shamieh S, Benachour H, Labat C, Herbeth B, Ndiaye NC, Masson C, Visvikis-Siest S, Benetos A. Klotho KL-VS genotype is involved in blood pressure regulation. Clin Chim Acta. 2011 Sep 18;412(19-20):1773-7. doi: 10.1016/j.cca.2011.05.032. Epub 2011 Jun 1.
- Zhou X, Chen K, Lei H, Sun Z. Klotho gene deficiency causes salt-sensitive hypertension via monocyte chemotactic protein-1/CC chemokine receptor 2-mediated inflammation. J Am Soc Nephrol. 2015 Jan;26(1):121-32. doi: 10.1681/ASN.2013101033. Epub 2014 Jun 5.
- Manunta P, Lavery G, Lanzani C, Braund PS, Simonini M, Bodycote C, Zagato L, Delli Carpini S, Tantardini C, Brioni E, Bianchi G, Samani NJ. Physiological interaction between alpha-adducin and WNK1-NEDD4L pathways on sodium-related blood pressure regulation. Hypertension. 2008 Aug;52(2):366-72. doi: 10.1161/HYPERTENSIONAHA.108.113977. Epub 2008 Jun 30.
- Citterio L, Simonini M, Zagato L, Salvi E, Delli Carpini S, Lanzani C, Messaggio E, Casamassima N, Frau F, D'Avila F, Cusi D, Barlassina C, Manunta P. Genes involved in vasoconstriction and vasodilation system affect salt-sensitive hypertension. PLoS One. 2011 May 9;6(5):e19620. doi: 10.1371/journal.pone.0019620.
- Trudu M, Janas S, Lanzani C, Debaix H, Schaeffer C, Ikehata M, Citterio L, Demaretz S, Trevisani F, Ristagno G, Glaudemans B, Laghmani K, Dell'Antonio G; SKIPOGH team; Loffing J, Rastaldi MP, Manunta P, Devuyst O, Rampoldi L. Common noncoding UMOD gene variants induce salt-sensitive hypertension and kidney damage by increasing uromodulin expression. Nat Med. 2013 Dec;19(12):1655-60. doi: 10.1038/nm.3384. Epub 2013 Nov 3.
- Kuznetsova T, Staessen JA, Thijs L, Kunath C, Olszanecka A, Ryabikov A, Tikhonoff V, Stolarz K, Bianchi G, Casiglia E, Fagard R, Brand-Herrmann SM, Kawecka-Jaszcz K, Malyutina S, Nikitin Y, Brand E; European Project On Genes in Hypertension (EPOGH) Investigators. Left ventricular mass in relation to genetic variation in angiotensin II receptors, renin system genes, and sodium excretion. Circulation. 2004 Oct 26;110(17):2644-50. doi: 10.1161/01.CIR.0000145541.63406.BA. Epub 2004 Oct 18.
- Munshi A, Sharma V, Kaul S, Rajeshwar K, Babu MS, Shafi G, Anila AN, Balakrishna N, Alladi S, Jyothy A. Association of the -344C/T aldosterone synthase (CYP11B2) gene variant with hypertension and stroke. J Neurol Sci. 2010 Sep 15;296(1-2):34-8. doi: 10.1016/j.jns.2010.06.013. Epub 2010 Jul 3. Erratum In: J Neurol Sci. 2012 Oct 15;321(1-2):122.
- Tanase DM, Gosav EM, Radu S, Ouatu A, Rezus C, Ciocoiu M, Costea CF, Floria M. Arterial Hypertension and Interleukins: Potential Therapeutic Target or Future Diagnostic Marker? Int J Hypertens. 2019 May 2;2019:3159283. doi: 10.1155/2019/3159283. eCollection 2019.
- Li Y, Thijs L, Kuznetsova T, Zagato L, Struijker-Boudier H, Bianchi G, Staessen JA. Cardiovascular risk in relation to alpha-adducin Gly460Trp polymorphism and systolic pressure: a prospective population study. Hypertension. 2005 Sep;46(3):527-32. doi: 10.1161/01.HYP.0000174988.81829.72. Epub 2005 Jul 25.
- Manunta P, Ferrandi M, Cusi D, Ferrari P, Staessen J, Bianchi G. Personalized Therapy of Hypertension: the Past and the Future. Curr Hypertens Rep. 2016 Mar;18(3):24. doi: 10.1007/s11906-016-0632-y.
- Seidlerova J, Staessen JA, Bochud M, Nawrot T, Casamassima N, Citterio L, Kuznetsova T, Jin Y, Manunta P, Richart T, Struijker-Boudier HA, Fagard R, Filipovsky J, Bianchi G. Arterial properties in relation to genetic variations in the adducin subunits in a white population. Am J Hypertens. 2009 Jan;22(1):21-6. doi: 10.1038/ajh.2008.261. Epub 2008 Sep 11.
- Iatrino R, Lanzani C, Bignami E, Casamassima N, Citterio L, Meroni R, Zagato L, Zangrillo A, Alfieri O, Fontana S, Macrina L, Delli Carpini S, Messaggio E, Brioni E, Dell'Antonio G, Manunta P, Hamlyn JM, Simonini M. Lanosterol Synthase Genetic Variants, Endogenous Ouabain, and Both Acute and Chronic Kidney Injury. Am J Kidney Dis. 2019 Apr;73(4):504-512. doi: 10.1053/j.ajkd.2018.10.012. Epub 2019 Jan 16.
- Citterio L, Ferrandi M, Delli Carpini S, Simonini M, Kuznetsova T, Molinari I, Dell' Antonio G, Lanzani C, Merlino L, Brioni E, Staessen JA, Bianchi G, Manunta P. cGMP-dependent protein kinase 1 polymorphisms underlie renal sodium handling impairment. Hypertension. 2013 Dec;62(6):1027-33. doi: 10.1161/HYPERTENSIONAHA.113.01628. Epub 2013 Sep 23.
- Kawasaki T, Itoh K, Uezono K, Sasaki H. A simple method for estimating 24 h urinary sodium and potassium excretion from second morning voiding urine specimen in adults. Clin Exp Pharmacol Physiol. 1993 Jan;20(1):7-14. doi: 10.1111/j.1440-1681.1993.tb01496.x. Erratum In: Clin Exp Pharmacol Physiol 1993 Mar;20(3):199.
- Cappuccio FP, Ji C, Donfrancesco C, Palmieri L, Ippolito R, Vanuzzo D, Giampaoli S, Strazzullo P. Geographic and socioeconomic variation of sodium and potassium intake in Italy: results from the MINISAL-GIRCSI programme. BMJ Open. 2015 Sep 10;5(9):e007467. doi: 10.1136/bmjopen-2014-007467.
- Welsh CE, Welsh P, Jhund P, Delles C, Celis-Morales C, Lewsey JD, Gray S, Lyall D, Iliodromiti S, Gill JMR, Sattar N, Mark PB. Urinary Sodium Excretion, Blood Pressure, and Risk of Future Cardiovascular Disease and Mortality in Subjects Without Prior Cardiovascular Disease. Hypertension. 2019 Jun;73(6):1202-1209. doi: 10.1161/HYPERTENSIONAHA.119.12726.
- Andrukhova O, Slavic S, Smorodchenko A, Zeitz U, Shalhoub V, Lanske B, Pohl EE, Erben RG. FGF23 regulates renal sodium handling and blood pressure. EMBO Mol Med. 2014 Jun;6(6):744-59. doi: 10.1002/emmm.201303716. Epub 2014 Apr 6.
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- Taylor WR. Hypertensive vascular disease and inflammation: mechanical and humoral mechanisms. Curr Hypertens Rep. 1999 Feb-Mar;1(1):96-101. doi: 10.1007/s11906-999-0079-5.
- Libby P. Interleukin-1 Beta as a Target for Atherosclerosis Therapy: Biological Basis of CANTOS and Beyond. J Am Coll Cardiol. 2017 Oct 31;70(18):2278-2289. doi: 10.1016/j.jacc.2017.09.028.
- Li QZ, Deng Q, Li JQ, Yi GH, Zhao SP. Valsartan reduces interleukin-1beta secretion by peripheral blood mononuclear cells in patients with essential hypertension. Clin Chim Acta. 2005 May;355(1-2):131-6. doi: 10.1016/j.cccn.2004.12.006.
- Elijovich F, Weinberger MH, Anderson CA, Appel LJ, Bursztyn M, Cook NR, Dart RA, Newton-Cheh CH, Sacks FM, Laffer CL; American Heart Association Professional and Public Education Committee of the Council on Hypertension; Council on Functional Genomics and Translational Biology; and Stroke Council. Salt Sensitivity of Blood Pressure: A Scientific Statement From the American Heart Association. Hypertension. 2016 Sep;68(3):e7-e46. doi: 10.1161/HYP.0000000000000047. Epub 2016 Jul 21. No abstract available. Erratum In: Hypertension. 2016 Oct;68(4):e62.
- Lin RC, Morris BJ. Association analysis of polymorphisms at the interleukin-1 locus in essential hypertension. Am J Med Genet. 2002 Feb 1;107(4):311-6. doi: 10.1002/ajmg.10177.
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- Jin Y, Kuznetsova T, Citterio L, Thijs L, Messaggio E, Casamassima N, Manunta P, Fagard R, Bianchi G, Staessen JA. Left ventricular structure and function in relation to steroid biosynthesis genes in a white population. Am J Hypertens. 2012 Sep;25(9):986-93. doi: 10.1038/ajh.2012.69. Epub 2012 Jun 7.
- Tentori S, Messaggio E, Brioni E, Casamassima N, Simonini M, Zagato L, Hamlyn JM, Manunta P, Lanzani C. Endogenous ouabain and aldosterone are coelevated in the circulation of patients with essential hypertension. J Hypertens. 2016 Oct;34(10):2074-80. doi: 10.1097/HJH.0000000000001042.
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYGEF STUDY
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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