Effects of Different Doses of Aspirin on Pathophysiological Markers in Type 2 Diabetes

University of Portsmouth21 enrolled

Overview

This study was set up to assess the effects of different doses of aspirin when compared with placebo (dummy drug), used sequentially over a 2 week study period with a 2 week wash-out (rest period) in between, in people with type-2 diabetes and high cardiovascular risk. Specifically, its effects on different factors which are thought to contribute to diabetes such as insulin resistance (body's ability to effectively use insulin), dysglycaemia (excess glucose in the blood), oxidative stress (effects from accumulation of by-products of metabolism), endothelial function (function of lining of blood vessels) and inflammation were studied.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Type 2

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * diabetes type 2 * age \> 18 and \< 70 * high cardiovascular risk Exclusion Criteria: * presence of active/established cardiovascular disease (ischaemic heart disease, cerebrovascular disease or peripheral vascular disease) * insulin treatment * patients with known peptic ulcer disease or those on anti-coagulation * significant renal impairment * aspirin intolerance * use of anticoagulants * significant liver disease

Locations (2)

School of Pharmacy and Biomedical Sciences, University of Posrtmouth

Portsmouth, Hampshire, United Kingdom

Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, United Kingdom

Outcomes

Primary Outcomes

Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance

Time frame: 2 weeks

Secondary Outcomes

Change in inflammatory markers

Time frame: 2 weeks