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

This study has been completed.
Sponsor:
Information provided by:
University of Portsmouth
ClinicalTrials.gov Identifier:
NCT00898950
First received: May 11, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in inflammatory markers [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898950

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

No publications provided

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
Study First Received: May 11, 2009
Last Updated: May 11, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Inflammation
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013