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

May 11, 2009 updated by: University of Portsmouth

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO1 2DT
        • School of Pharmacy and Biomedical Sciences, University of Posrtmouth
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Other: placebo tablet
placebo tablet with lactose and excipients.
Experimental: Aspirin low dose
Effects of using aspirin 75 mgs/day for 2 weeks.
Drug: Aspirin
Aspirin 75mgs/day orally for 2 weeks.
Other Names:
  • acetyl salicylic acid
Drug: Aspirin
300mgs/day orally for 2 weeks
Other Names:
  • acetyl salicylic acid
Drug: Aspirin
aspirin 900mgs QID orally for 2 weeks
Other Names:
  • acetyl salicylic acid
Experimental: Aspirin medium dose
Effects of using aspirin 300 mgs/day
Drug: Aspirin
Aspirin 75mgs/day orally for 2 weeks.
Other Names:
  • acetyl salicylic acid
Drug: Aspirin
300mgs/day orally for 2 weeks
Other Names:
  • acetyl salicylic acid
Drug: Aspirin
aspirin 900mgs QID orally for 2 weeks
Other Names:
  • acetyl salicylic acid
Experimental: aspirin high dose
aspirin 900mgs QID orally for 2 weeks
Drug: Aspirin
Aspirin 75mgs/day orally for 2 weeks.
Other Names:
  • acetyl salicylic acid
Drug: Aspirin
300mgs/day orally for 2 weeks
Other Names:
  • acetyl salicylic acid
Drug: Aspirin
aspirin 900mgs QID orally for 2 weeks
Other Names:
  • acetyl salicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in inflammatory markers
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Portsmouth

Investigators

  • Principal Investigator: Rajeev P Raghavan, MBBS, MRCP, Portsmouth Hospitals NHS Trust
  • Study Director: Michael H Cummings, MD, FRCP, Portsmouth Hospitals NHS TRust & University of Portsmouth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

May 12, 2009

Last Update Submitted That Met QC Criteria

May 11, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-001418-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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