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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00898950
First Posted: May 12, 2009
Last Update Posted: May 12, 2009
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.
Information provided by:
University of Portsmouth
  Purpose
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 Intervention
Diabetes Type 2 Drug: Aspirin Other: placebo tablet

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Portsmouth:

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

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

Enrollment: 21
Study Start Date: August 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00898950


Locations
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
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr MH Cummings, Portsmouth Hospitals NHS Trust & University of Portsmouth
ClinicalTrials.gov Identifier: NCT00898950     History of Changes
Other Study ID Numbers: 2004-001418-14
First Submitted: May 11, 2009
First Posted: May 12, 2009
Last Update Posted: May 12, 2009
Last Verified: May 2009

Keywords provided by University of Portsmouth:
diabetes
aspirin
oxidative stress
insulin resistance
endothelial function
inflammation
photoplethysmography
dysglycaemia

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Aspirin
Salicylates
Salicylic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antipyretics
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents