Contact information
Type
Scientific
Primary contact
Dr Matthew Walters
ORCID ID
Contact details
Department of Medicine & Therapeutics
Western Infirmary
44 Church Street
Glasgow
G11 6NT
United Kingdom
+44 (0)141 211 2821
gcl203@clinmed.gla.ac.uk
Additional identifiers
EudraCT number
2005-001670-27
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The purpose of the study is to investigate the effect of both losartan and atenolol upon impaired cerebrovascular reactivity in diabetic patients.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Losartan and atenolol
Primary outcome measure
The aim of the study is to investigate the potential reversibility of the observed impairment of endothelial function.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/2005
Overall trial end date
01/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Type II diabetes <5 years duration
2. Age >40 years
3. Normal full Bruce protocol exercise tolerance test
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
18
Participant 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 Ongoing treatment with ARB/ACE1/beta-blocker unless can be withdrawn 4 weeks prior to randomisation
Recruitment start date
01/07/2005
Recruitment end date
01/07/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medicine & Therapeutics
Glasgow
G11 6NT
United Kingdom
Sponsor information
Organisation
University of Glasgow (UK)
Sponsor details
University Avenue
Glasgow
G11 6NT
United Kingdom
+44 (0)141 339 8855
pcn1w@clinmed.gla.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Glasgow (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18945924
Publication citations
-
Results
Dawson J, Quinn T, Harrow C, Lees KR, Weir CJ, Cleland SJ, Walters MR, Allopurinol and nitric oxide activity in the cerebral circulation of those with diabetes: a randomized trial., Diabetes Care, 2009, 32, 1, 135-137, doi: 10.2337/dc08-1179.