FGF21 Can Help Predicting Arterial Stiffness Measured by Cardio-ankle Vascular Index in Renal Transplant Patients

NCT02704468 | Completed DMC

• 1 other identifier: 085/58
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic kidney disease(CKD) patients have high incidence of coronary artery problems event after renal transplantation. And remain a major cause of mortality. The major risk marker is arterial stiffness. The cardio-ankle vascular index (CAVI) is a new index of overall stiffness and can estimated the risk of atherosclerosis. Fibroblast growth factor 21 (FGF-21) is a metabolic regulator that plays important role in cardiac remodeling elevated FGF-21 have been reported in coronary heart disease or carotid artery plaque and could be biomarkers for atherosclerosis disease Investigators aimed to study the association between CAVI and FGF-21 and their relations to various parameters that can contribute to cardiovascular disease eg. homocysteine Echocardiogram findings and other traditional basic factors.

Conditions

Vascular Stiffness

Keywords

CAVI; FGF-21; arterial stiffness; renal transplant

Outcome Measures

Primary Outcomes (1)

• association between CAVI and FGF-21 with arterial stiffness in renal transplant patients

  cross sectional study

  1 month

Secondary Outcomes (1)

• association between Hs-CRP,Homocystein with CAVI

  1 month

Study Arms (1)

CAVI and FGF-21

renal transplant patients for more than 1 month measured FGF-21 and CAVI

Other: CAVI and FGF-21

Interventions

CAVI and FGF-21 OTHER

FGf-21 and CAVI was measured in renal transplant patients group and study correlation with arterial stiffness

CAVI and FGF-21

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

renal transplant pateints for more than 1 month

You may qualify if:

• renal transplant patients patients for more than 1 month

You may not qualify if:

• who had contraindication for CAVI
• current smoker
• eGFR \<15 ml/min/173
• cardiac arrthymia

Sponsors & Collaborators

• Bangkok Metropolitan Administration Medical College and Vajira Hospital: lead

Study Sites (1)

Bangkok metropolitan administraiton of vajira hospital

Bangkok, Bangkok, 10170, Thailand

Location

Related Publications (27)

• Sarnak MJ, Levey AS, Schoolwerth AC, Coresh J, Culleton B, Hamm LL, McCullough PA, Kasiske BL, Kelepouris E, Klag MJ, Parfrey P, Pfeffer M, Raij L, Spinosa DJ, Wilson PW; American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Circulation. 2003 Oct 28;108(17):2154-69. doi: 10.1161/01.CIR.0000095676.90936.80. No abstract available.

  PMID: 14581387 BACKGROUND

• An SY, Lee MS, Yi SA, Ha ES, Han SJ, Kim HJ, Kim DJ, Lee KW. Serum fibroblast growth factor 21 was elevated in subjects with type 2 diabetes mellitus and was associated with the presence of carotid artery plaques. Diabetes Res Clin Pract. 2012 May;96(2):196-203. doi: 10.1016/j.diabres.2012.01.004. Epub 2012 Jan 30.

  PMID: 22293928 BACKGROUND

• Verbeke F, Marechal C, Van Laecke S, Van Biesen W, Devuyst O, Van Bortel LM, Jadoul M, Vanholder R. Aortic stiffness and central wave reflections predict outcome in renal transplant recipients. Hypertension. 2011 Nov;58(5):833-8. doi: 10.1161/HYPERTENSIONAHA.111.176594. Epub 2011 Sep 6.

  PMID: 21896935 BACKGROUND

• Khoshdel AR, Carney SL. Arterial stiffness in kidney transplant recipients: an overview of methodology and applications. Urol J. 2008 Winter;5(1):3-14.

  PMID: 18454420 BACKGROUND

• Stehouwer CD, Henry RM, Ferreira I. Arterial stiffness in diabetes and the metabolic syndrome: a pathway to cardiovascular disease. Diabetologia. 2008 Apr;51(4):527-39. doi: 10.1007/s00125-007-0918-3. Epub 2008 Feb 1.

  PMID: 18239908 BACKGROUND

• Sun CK. Cardio-ankle vascular index (CAVI) as an indicator of arterial stiffness. Integr Blood Press Control. 2013 Apr 30;6:27-38. doi: 10.2147/IBPC.S34423. Print 2013.

  PMID: 23667317 BACKGROUND

• Kim KJ, Lee BW, Kim HM, Shin JY, Kang ES, Cha BS, Lee EJ, Lim SK, Lee HC. Associations between cardio-ankle vascular index and microvascular complications in type 2 diabetes mellitus patients. J Atheroscler Thromb. 2011;18(4):328-36. doi: 10.5551/jat.5983. Epub 2011 Jan 6.

  PMID: 21224525 BACKGROUND

• Takaki A, Ogawa H, Wakeyama T, Iwami T, Kimura M, Hadano Y, Matsuda S, Miyazaki Y, Matsuda T, Hiratsuka A, Matsuzaki M. Cardio-ankle vascular index is a new noninvasive parameter of arterial stiffness. Circ J. 2007 Nov;71(11):1710-4. doi: 10.1253/circj.71.1710.

  PMID: 17965489 BACKGROUND

• Hayashi K, Sato M, Niimi H, Handa H, Moritake K. [Analysis of the constitutive laws of the vascular wall by finite deformation theory]. Iyodenshi To Seitai Kogaku. 1975 Oct;13(5):293-8. No abstract available. Japanese.

  PMID: 1240535 BACKGROUND

• KOTANI, K.; REMALEY, A. T. Cardio-AnkleVascular Index (CAVI) and its Potential Clinical Implications for Cardiovascular Disease. CardiolPharmacol, 2013, 2: 108.

  BACKGROUND

• Otsuka K, Fukuda S, Shimada K, Suzuki K, Nakanishi K, Yoshiyama M, Yoshikawa J. Serial assessment of arterial stiffness by cardio-ankle vascular index for prediction of future cardiovascular events in patients with coronary artery disease. Hypertens Res. 2014 Nov;37(11):1014-20. doi: 10.1038/hr.2014.116. Epub 2014 Jul 10.

  PMID: 25007768 BACKGROUND

• Dobsak P, Soska V, Sochor O, Jarkovsky J, Novakova M, Homolka M, Soucek M, Palanova P, Lopez-Jimenez F, Shirai K. Increased cardio-ankle vascular index in hyperlipidemic patients without diabetes or hypertension. J Atheroscler Thromb. 2015;22(3):272-83. doi: 10.5551/jat.24851. Epub 2014 Oct 22.

  PMID: 25342382 BACKGROUND

• Shirai K, Hiruta N, Song M, Kurosu T, Suzuki J, Tomaru T, Miyashita Y, Saiki A, Takahashi M, Suzuki K, Takata M. Cardio-ankle vascular index (CAVI) as a novel indicator of arterial stiffness: theory, evidence and perspectives. J Atheroscler Thromb. 2011;18(11):924-38. doi: 10.5551/jat.7716. Epub 2011 May 31.

  PMID: 21628839 BACKGROUND

• Cheng HM, Chuang SY, Sung SH, Yu WC, Pearson A, Lakatta EG, Pan WH, Chen CH. Derivation and validation of diagnostic thresholds for central blood pressure measurements based on long-term cardiovascular risks. J Am Coll Cardiol. 2013 Nov 5;62(19):1780-7. doi: 10.1016/j.jacc.2013.06.029. Epub 2013 Jul 10.

  PMID: 23850921 BACKGROUND

• Jin K, LaFevre-Bernt M, Sun Y, Chen S, Gafni J, Crippen D, Logvinova A, Ross CA, Greenberg DA, Ellerby LM. FGF-2 promotes neurogenesis and neuroprotection and prolongs survival in a transgenic mouse model of Huntington's disease. Proc Natl Acad Sci U S A. 2005 Dec 13;102(50):18189-94. doi: 10.1073/pnas.0506375102. Epub 2005 Dec 2.

  PMID: 16326808 BACKGROUND

• Kharitonenkov A, Shiyanova TL, Koester A, Ford AM, Micanovic R, Galbreath EJ, Sandusky GE, Hammond LJ, Moyers JS, Owens RA, Gromada J, Brozinick JT, Hawkins ED, Wroblewski VJ, Li DS, Mehrbod F, Jaskunas SR, Shanafelt AB. FGF-21 as a novel metabolic regulator. J Clin Invest. 2005 Jun;115(6):1627-35. doi: 10.1172/JCI23606. Epub 2005 May 2.

  PMID: 15902306 BACKGROUND

• Coskun T, Bina HA, Schneider MA, Dunbar JD, Hu CC, Chen Y, Moller DE, Kharitonenkov A. Fibroblast growth factor 21 corrects obesity in mice. Endocrinology. 2008 Dec;149(12):6018-27. doi: 10.1210/en.2008-0816. Epub 2008 Aug 7.

  PMID: 18687777 BACKGROUND

• Kharitonenkov A, Wroblewski VJ, Koester A, Chen YF, Clutinger CK, Tigno XT, Hansen BC, Shanafelt AB, Etgen GJ. The metabolic state of diabetic monkeys is regulated by fibroblast growth factor-21. Endocrinology. 2007 Feb;148(2):774-81. doi: 10.1210/en.2006-1168. Epub 2006 Oct 26.

  PMID: 17068132 BACKGROUND

• Ong KL, Januszewski AS, O'Connell R, Jenkins AJ, Xu A, Sullivan DR, Barter PJ, Hung WT, Scott RS, Taskinen MR, Keech AC, Rye KA. The relationship of fibroblast growth factor 21 with cardiovascular outcome events in the Fenofibrate Intervention and Event Lowering in Diabetes study. Diabetologia. 2015 Mar;58(3):464-73. doi: 10.1007/s00125-014-3458-7. Epub 2014 Nov 26.

  PMID: 25425220 BACKGROUND

• Lin Z, Wu Z, Yin X, Liu Y, Yan X, Lin S, Xiao J, Wang X, Feng W, Li X. Serum levels of FGF-21 are increased in coronary heart disease patients and are independently associated with adverse lipid profile. PLoS One. 2010 Dec 29;5(12):e15534. doi: 10.1371/journal.pone.0015534.

  PMID: 21206918 BACKGROUND

• Mirza MA, Hansen T, Johansson L, Ahlstrom H, Larsson A, Lind L, Larsson TE. Relationship between circulating FGF23 and total body atherosclerosis in the community. Nephrol Dial Transplant. 2009 Oct;24(10):3125-31. doi: 10.1093/ndt/gfp205. Epub 2009 May 9.

  PMID: 19429932 BACKGROUND

• Lee Y, Lim S, Hong ES, Kim JH, Moon MK, Chun EJ, Choi SI, Kim YB, Park YJ, Park KS, Jang HC, Choi SH. Serum FGF21 concentration is associated with hypertriglyceridaemia, hyperinsulinaemia and pericardial fat accumulation, independently of obesity, but not with current coronary artery status. Clin Endocrinol (Oxf). 2014 Jan;80(1):57-64. doi: 10.1111/cen.12134. Epub 2013 May 6.

  PMID: 23278761 BACKGROUND

• Mahabadi AA, Massaro JM, Rosito GA, Levy D, Murabito JM, Wolf PA, O'Donnell CJ, Fox CS, Hoffmann U. Association of pericardial fat, intrathoracic fat, and visceral abdominal fat with cardiovascular disease burden: the Framingham Heart Study. Eur Heart J. 2009 Apr;30(7):850-6. doi: 10.1093/eurheartj/ehn573. Epub 2009 Jan 9.

  PMID: 19136488 BACKGROUND

• Chow WS, Xu A, Woo YC, Tso AW, Cheung SC, Fong CH, Tse HF, Chau MT, Cheung BM, Lam KS. Serum fibroblast growth factor-21 levels are associated with carotid atherosclerosis independent of established cardiovascular risk factors. Arterioscler Thromb Vasc Biol. 2013 Oct;33(10):2454-9. doi: 10.1161/ATVBAHA.113.301599. Epub 2013 Jul 25.

  PMID: 23887638 BACKGROUND

• Semba RD, Crasto C, Strait J, Sun K, Schaumberg DA, Ferrucci L. Elevated serum fibroblast growth factor 21 is associated with hypertension in community-dwelling adults. J Hum Hypertens. 2013 Jun;27(6):397-9. doi: 10.1038/jhh.2012.52. Epub 2012 Nov 29.

  PMID: 23190795 BACKGROUND

• Chen YC, Lee MC, Lee CJ, Ho GJ, Yin WY, Chang YJ, Hsu BG. N-terminal pro-B-type natriuretic peptide is associated with arterial stiffness measured using the cardio-ankle vascular index in renal transplant recipients. J Atheroscler Thromb. 2013;20(7):646-53. doi: 10.5551/jat.17780. Epub 2013 May 10.

  PMID: 23665842 BACKGROUND

• Deo R, Shou H, Soliman EZ, Yang W, Arkin JM, Zhang X, Townsend RR, Go AS, Shlipak MG, Feldman HI. Electrocardiographic Measures and Prediction of Cardiovascular and Noncardiovascular Death in CKD. J Am Soc Nephrol. 2016 Feb;27(2):559-69. doi: 10.1681/ASN.2014101045. Epub 2015 Jul 9.

  PMID: 26160896 BACKGROUND

MeSH Terms

Interventions

fibroblast growth factor 21

Study Officials

• Thananda Trakarnvanich, M.D.

  Bangkok metropolitan administration medical college of vajira hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 10, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 19, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)