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

Charlotte E. Mills; Virginia Govoni; Maria Linda Casagrande; Luca Faconti; Andrew J. Webb; J. Kennedy Cruickshank

doi:10.1016/j.artres.2015.10.194

<Previous Article In Issue

Next Article In Issue>

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. Mills^a^{, b}^{, *}, Virginia Govoni^a^{, b}, Maria Linda Casagrande^a^{, b}, Luca Faconti^a^{, b}, Andrew J. Webb^b^{, c}, J. Kennedy Cruickshank^a^{, 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.2015.10.194 How 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.
Open Access: This is an open access article distributed under the CC BY-NC license.

Download article (PDF)
View full text (HTML)

<Previous Article In Issue

Next Article In Issue>

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.2015.10.194 How to use a DOI?
Open Access: This is an open access article distributed under the CC BY-NC license.

Cite this article

ris enw bib

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  -

download .riscopy to clipboard