Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/09/2005
Date assigned
27/10/2005
Last edited
23/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18945924

Publication citations

  1. 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.

Additional files

Editorial Notes