Reversibility of cerebrovascular endothelial dysfunction in diabetes: the role of allopurinol.

Conditions: Type Two Diabetes Mellitus

Registration Number: EUCTR2005-001670-27-GB

Lead Sponsor: Greater Glasgow NHS Health Board / University of Glasgow co-sponsorship

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 24

Inclusion Criteria

Type II diabetes of less than 5 years' duration treated with diet, metformin, thiazolidinediones or a combination of above
Age > 40 years
Normal full Bruce protocol exercise tolerance test
Favourable temporal bony window
Stable glycaemic control (HbA1c < 9.0%)
Stable cholesterol (total cholesterol < 7.5
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

>70% extra-cranial internal carotid artery stenosis
Known coronary arterial disease
Significant co-morbidity
Contra-indication to or indication for administration of allopurinol
Concurrent azathioprine or 6-mercaptopurine therapy
Insulin or sulphonylurea therapy
Serum creatinine concentration greater than 250 micromoles per litre

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the proposed program is to explore the mechanistic basis of impaired cerebrovascular nitric oxide bioavailability in patients with diabetes and to identify whether the observed abnormality can be reversed with pharmacological intervention using the xanthine oxidase inhibitor allopurinol.;Secondary Objective: ;Primary end point(s): The variable used for comparison between treatments will be the change in ICA flow (area under flow / time curve) induced by the L-NMMA infusion.

Secondary Outcome Measures