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

Not Applicable

Completed

• Conditions: Diabetes Type 2
• Interventions: Other: placebo tablet; Drug: Aspirin

• Registration Number: NCT00898950
• Lead Sponsor: University of Portsmouth

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2009-05
• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-11
• Last Update Submitted: 2009-05-11
• Study First Posted: 2009-05-12
• Last Update Posted: 2009-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	placebo tablet	-
Aspirin low dose	Aspirin	Effects of using aspirin 75 mgs/day for 2 weeks.
Aspirin medium dose	Aspirin	Effects of using aspirin 300 mgs/day
aspirin high dose	Aspirin	aspirin 900mgs QID orally for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance	2 weeks

Secondary Outcome Measures

Name	Time	Method
Change in inflammatory markers	2 weeks

Trial Locations

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