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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00898950
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 12, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Drug: Aspirin Other: placebo tablet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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 Start Date : August 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin low dose
Effects of using aspirin 75 mgs/day for 2 weeks.
Drug: Aspirin
Aspirin 75mgs/day orally for 2 weeks.
Other Name: acetyl salicylic acid

Experimental: Aspirin medium dose
Effects of using aspirin 300 mgs/day
Drug: Aspirin
300mgs/day orally for 2 weeks
Other Name: acetyl salicylic acid

Experimental: aspirin high dose
aspirin 900mgs QID orally for 2 weeks
Drug: Aspirin
aspirin 900mgs QID orally for 2 weeks
Other Name: acetyl salicylic acid

Placebo Comparator: placebo Other: placebo tablet
placebo tablet with lactose and excipients.

Primary Outcome Measures :
  1. Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Change in inflammatory markers [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00898950

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United Kingdom
School of Pharmacy and Biomedical Sciences, University of Posrtmouth
Portsmouth, Hampshire, United Kingdom, PO1 2DT
Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Sponsors and Collaborators
University of Portsmouth
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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 automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr MH Cummings, Portsmouth Hospitals NHS Trust & University of Portsmouth Identifier: NCT00898950    
Other Study ID Numbers: 2004-001418-14
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: May 12, 2009
Last Verified: May 2009
Keywords provided by University of Portsmouth:
oxidative stress
insulin resistance
endothelial function
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Salicylic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents