Reversibility of cerebrovascular endothelial dysfunction in patients with diabetes

ISRCTN	ISRCTN15728912
DOI	https://doi.org/10.1186/ISRCTN15728912
EudraCT/CTIS number	2005-001670-27
Secondary identifying numbers	N/A

Submission date: 08/09/2005
Registration date: 27/10/2005
Last edited: 23/08/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	01/07/2005
Completion date	01/07/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Department of Medicine & Therapeutics

Glasgow
G11 6NT
United Kingdom

Sponsor information

University of Glasgow (UK)
University/education

University Avenue
Glasgow
G11 6NT
Scotland
United Kingdom

Phone	+44 (0)141 339 8855
Email	pcn1w@clinmed.gla.ac.uk
"ROR"	https://ror.org/00vtgdb53

Funders

Funder type

University/education

University of Glasgow (UK)
Private sector organisation / Universities (academic only)

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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