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
- 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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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 -