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  • Diverging effects of diabetes mellitus in patients with peripheral artery disease and abdominal aortic aneurysm and the role of advanced glycation end-products: ARTERY study — protocol for a multicentre cross-sectional study

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Cardiovascular medicine
Protocol
Diverging effects of diabetes mellitus in patients with peripheral artery disease and abdominal aortic aneurysm and the role of advanced glycation end-products: ARTERY study — protocol for a multicentre cross-sectional study
  1. L C de Vos1,
  2. J Boersema1,
  3. J L Hillebrands2,
  4. C G Schalkwijk3,
  5. R Meerwaldt4,
  6. J C Breek5,
  7. A J Smit1,
  8. C J Zeebregts6,
  9. J D Lefrandt1
  1. 1Department of Internal Medicine, Division of Vascular Medicine, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands
  2. 2Department of Pathology and Medical Biology, Division of Pathology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands
  3. 3Department of Internal Medicine, Laboratory for Metabolism and Vascular Medicine, Maastricht University, Maastricht, the Netherlands
  4. 4Department of Vascular Surgery, Medisch Spectrum Twente, Enschede, the Netherlands
  5. 5Department of Vascular Surgery, Martini Hospital, Groningen, the Netherlands
  6. 6Department of Surgery, Division of Vascular Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands
  1. Correspondence to Professor AJ Smit; a.j.smit{at}umcg.nl

Abstract

Introduction Diabetes mellitus is a well-defined risk factor for peripheral artery disease (PAD), but protects against the development and growth of abdominal aortic aneurysm (AAA). Diabetes mellitus is associated with arterial stiffening and peripheral arterial media sclerosis. Advanced glycation end-products (AGEs) are increased in diabetes mellitus and cardiovascular disease. AGEs are known to form cross-links between proteins and are associated with arterial stiffness. Whether AGEs contribute to the protective effects of diabetes mellitus in AAA is unknown. Therefore, the ARTERY (Advanced glycation end-pRoducts in patients with peripheral arTery disEase and abdominal aoRtic aneurYsm) study is designed to evaluate the role of AGEs in the diverging effects of diabetes mellitus on AAA and PAD.

Methods and analysis This cross-sectional multicentre study will compare the amount, type and location of AGEs in the arterial wall in a total of 120 patients with AAA or PAD with and without diabetes mellitus (n=30 per subgroup). Also, local and systemic vascular parameters, including pulse wave velocity, will be measured to evaluate the association between arterial stiffness and AGEs. Finally, AGEs will be measured in serum, urine, and assessed in skin with skin autofluorescence using the AGE Reader.

Ethics and dissemination This study is approved by the Medical Ethics committees of University Medical Center Groningen, Martini Hospital and Medisch Spectrum Twente, the Netherlands. Study results will be disseminated through peer-reviewed journals and scientific events.

Trial registration number trialregister.nl NTR 5363.

  • Advanced glycation end products
  • Peripheral artery disease
  • Abdominal aortic aneurysm
  • Diabetes mellitus

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-012584

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    Footnotes

    • Contributors LCdV, CJZ and JDL conceived the ARTERY study. LCdV drafted the first version of this manuscript. LCdV and JB are responsible for the management of the study. All authors read, revised and approved the final manuscript and also contributed to the design of the ARTERY study.

    • Funding This study is partly funded from bench fee provided for PhD students from the Junior Scientific Masterclass, University Medical Center Groningen. Additionally, an unrestricted grant from Sanofi-Aventis Nederland B.V. (grant number 13375000007024/R1/TP) and a financial contribution from the Jan Kornelis de Cock-Hadders foundation was provided.

    • Competing interests AJS is a founder and shareholder of DiagnOptics BV, the Netherlands, manufacturing autofluorescence readers (http://www.diagnoptics.com). All other authors have nothing to disclose related to this paper.

    • Ethics approval Ethical approval was obtained from the Medical Ethics committee, University Medical Center Groningen, Groningen, the Netherlands (METc 2014/269). Local approval for the ARTERY study was given by the Medical Ethics committee and the board of directors of the Martini Hospital (METc 2014/269) and MST (METc H15-076).

    • Provenance and peer review Not commissioned; externally peer reviewed.