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

Information source: University of Portsmouth
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Type 2

Intervention: Aspirin (Drug); Aspirin (Drug); Aspirin (Drug); placebo tablet (Other)

Phase: N/A

Status: Completed

Sponsored by: University of Portsmouth

Official(s) and/or principal investigator(s):
Rajeev P Raghavan, MBBS, MRCP, Principal Investigator, Affiliation: Portsmouth Hospitals NHS Trust
Michael H Cummings, MD, FRCP, Study Director, Affiliation: Portsmouth Hospitals NHS TRust & University of Portsmouth

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.

Clinical Details

Official title: The Links Between Dysglycaemia, Insulin Resistance, Endothelial Function, Inflammation and Oxidative Stress: Effect of Different Doses of Aspirin in Subjects With Type-2 Diabetes and High Cardiovascular Risk

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

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

Secondary outcome: Change in inflammatory markers

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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 and Contacts

Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, Hampshire PO6 3LY, United Kingdom

School of Pharmacy and Biomedical Sciences, University of Posrtmouth, Portsmouth, Hampshire PO1 2DT, United Kingdom

Additional Information

Starting date: August 2004
Last updated: May 11, 2009

Page last updated: August 20, 2015

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