Artery Research

Volume 12, Issue C, December 2015, Pages 48 - 53

Design and progress of a factorial trial testing the effect of spironolactone and inorganic nitrate on arterial function in people at risk of or with type 2 diabetes

Authors
Charlotte E. Millsa, b, *, Virginia Govonia, b, Maria Linda Casagrandea, b, Luca Facontia, b, Andrew J. Webbb, c, J. Kennedy Cruickshanka, b
aCardiovascular Medicine Group, Division of Diabetes and Nutritional Sciences, King’s College, 4th Floor Franklin Wilkins Building, London, UK
bBiomedical Research Centre, Clinical Research Facility, 4th Floor, North Wing, St Thomas’ Hospital, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
cDepartment of Clinical Pharmacology, British Heart Foundation Centre, Cardiovascular Division, 4th Floor, North Wing, St Thomas’ Hospital, King’s College London, UK
*Corresponding author. King’s College London, 4th Floor Franklin Wilkins Building, Stamford Street, London SE1 0NH, UK. Tel.: +44 (0) 207 848 4301. E-mail address: charlotte.1.mills@kcl.ac.uk (C.E. Mills).
Corresponding Author
Charlotte E. Mills
Received 8 September 2015, Revised 8 October 2015, Accepted 9 October 2015, Available Online 6 November 2015.
DOI
10.1016/j.artres.2015.10.194How to use a DOI?
Keywords
Arterial stiffness; Pulse wave velocity (PWV); Cardio-ankle vascular index (CAVI); Spironolactone; Beetroot; Nitrate
Abstract

Background: Arterial stiffness (AS), as pulse wave velocity (PWV), is a powerful independent predictor of cardiovascular events and commonly complicates type 2 diabetes (T2D). This trial aims to test if AS, measured by the VaSera machine as cardio-ankle vascular index (CAVI) and by Arteriograph measuring central PWV, can be reduced by spironolactone and/or inorganic nitrate from beetroot juice independently of blood pressure (BP) in those with or at risk of T2D.

Methods: A factorial design, double blind, randomised controlled trial in 18–80 year old men and women clinically diagnosed with T2D or at risk of it (body mass index (BMI) ≥ 27 kg m−2, positive family history or glucose intolerance). The study lasts up to 36 weeks with daily intervention of either ≤50 mg spironolactone (intervention) or ≤16 mg doxazosin (control), and beetroot juice with ≤400 mg (9 mmol) inorganic nitrate (intervention) or placebo beetroot juice, 0 mg nitrate (control). Non-invasive AS measurements are carried out at baseline and then at 12-week intervals thereafter.

Results: To date, 95 participants have been consented and screened, 19 of these were not suitable or not willing to participate so that 73 have been randomised with 9 participants screened as eligible and awaiting randomisation. 53 participants have completed the study. Mean baseline and follow up measures of cardiac-ankle and cardiac-aortic bifurcation PWV and BP have been straightforward.

Conclusion: This is a proof-of-principle trial to alter AS independent of BP in a patient sample at high cardiovascular risk.

Clinical trial registration information: UK Clinical Research Network Portfolio Database: 25003627.

Copyright
© 2015 Association for Research into Arterial Structure and Physiology. Published by Elsevier B.V. All rights reserved.
Open Access
This is an open access article distributed under the CC BY-NC license.

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Journal
Artery Research
Volume-Issue
12 - C
Pages
48 - 53
Publication Date
2015/11/06
ISSN (Online)
1876-4401
ISSN (Print)
1872-9312
DOI
10.1016/j.artres.2015.10.194How to use a DOI?
Copyright
© 2015 Association for Research into Arterial Structure and Physiology. Published by Elsevier B.V. All rights reserved.
Open Access
This is an open access article distributed under the CC BY-NC license.

Cite this article

TY  - JOUR
AU  - Charlotte E. Mills
AU  - Virginia Govoni
AU  - Maria Linda Casagrande
AU  - Luca Faconti
AU  - Andrew J. Webb
AU  - J. Kennedy Cruickshank
PY  - 2015
DA  - 2015/11/06
TI  - Design and progress of a factorial trial testing the effect of spironolactone and inorganic nitrate on arterial function in people at risk of or with type 2 diabetes
JO  - Artery Research
SP  - 48
EP  - 53
VL  - 12
IS  - C
SN  - 1876-4401
UR  - https://doi.org/10.1016/j.artres.2015.10.194
DO  - 10.1016/j.artres.2015.10.194
ID  - Mills2015
ER  -