Reversibility of cerebrovascular endothelial dysfunction in patients with diabetes

ISRCTN	ISRCTN15728912
DOI	https://doi.org/10.1186/ISRCTN15728912
Clinical Trials Information System (CTIS)	2005-001670-27
Protocol serial number	N/A
Sponsor	University of Glasgow (UK)
Funder	University of Glasgow (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Matthew Walters
Scientific

Department of Medicine & Therapeutics
Western Infirmary
44 Church Street
Glasgow
G11 6NT
United Kingdom

Phone	+44 (0)141 211 2821
Email	gcl203@clinmed.gla.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The purpose of the study is to investigate the effect of both losartan and atenolol upon impaired cerebrovascular reactivity in diabetic patients.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Diabetes
Intervention	Patients will undergo baseline assessment of cerebrovascular reactivity, mean flow velocity (MFV) in the middle cerebral artery (MCA) will be measured using transcranial Doppler. Each subject will then receive an intravenous infusion of L-NMMA after which MFV will be measured as before. Mean flow velocity in the internal carotid artery and peripheral arterial stiffness using Sphygmocor will also be assessed pre- and post-infusion for comparison. Patients then receive a supply of either losartan or atenolol tablets for 2 weeks after which they will undergo the same protocol as before. A 2-week washout period of no medication will follow, then the protocol repeated with the alternate tablet.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Losartan and atenolol
Primary outcome measure(s)	The aim of the study is to investigate the potential reversibility of the observed impairment of endothelial function.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/07/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	18
Key inclusion criteria	1. Type II diabetes <5 years duration 2. Age >40 years 3. Normal full Bruce protocol exercise tolerance test
Key exclusion criteria	1. >70% internal carotid artery (ICA) stenosis 2. Significant comorbidity 3. Contra-indication to administration of angiotensin II receptor blocker (ARB)/angiotensin converting enzyme (ACE)-1/beta-blocker 4. Ongoing treatment with ARB/ACE1/beta-blocker unless can be withdrawn 4 weeks prior to randomisation
Date of first enrolment	01/07/2005
Date of final enrolment	01/07/2006

Department of Medicine & Therapeutics

Glasgow
G11 6NT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2009		Yes	No