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

University of Portsmouth

Status: Completed

Conditions: Diabetes Type 2

Treatments: Drug: Aspirin; Other: placebo tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT00898950

2004-001418-14

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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21 participants in 4 patient groups, including a placebo group

Aspirin low dose

Experimental group

Description:

Effects of using aspirin 75 mgs/day for 2 weeks.

Treatment:

Drug: Aspirin

Drug: Aspirin

Drug: Aspirin

Aspirin medium dose

Experimental group

Description:

Effects of using aspirin 300 mgs/day

Treatment:

Drug: Aspirin

Drug: Aspirin

Drug: Aspirin

aspirin high dose

Experimental group

Description:

aspirin 900mgs QID orally for 2 weeks

Treatment:

Drug: Aspirin

Drug: Aspirin

Drug: Aspirin

placebo

Placebo Comparator group

Treatment:

Other: placebo tablet