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

May 11, 2009
May 11, 2009
August 2004
July 2006   (final data collection date for primary outcome measure)
Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Change in inflammatory markers [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Different Doses of Aspirin on Pathophysiological Markers in Type 2 Diabetes
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Diabetes Type 2
  • Drug: Aspirin
    Aspirin 75mgs/day orally for 2 weeks.
    Other Name: acetyl salicylic acid
  • Drug: Aspirin
    300mgs/day orally for 2 weeks
    Other Name: acetyl salicylic acid
  • Drug: Aspirin
    aspirin 900mgs QID orally for 2 weeks
    Other Name: acetyl salicylic acid
  • Other: placebo tablet
    placebo tablet with lactose and excipients.
  • Experimental: Aspirin low dose
    Effects of using aspirin 75 mgs/day for 2 weeks.
    Intervention: Drug: Aspirin
  • Experimental: Aspirin medium dose
    Effects of using aspirin 300 mgs/day
    Intervention: Drug: Aspirin
  • Experimental: aspirin high dose
    aspirin 900mgs QID orally for 2 weeks
    Intervention: Drug: Aspirin
  • Placebo Comparator: placebo
    Intervention: Other: placebo tablet
Raghavan RP, Laight DW, Cummings MH. Aspirin in type 2 diabetes, a randomised controlled study: effect of different doses on inflammation, oxidative stress, insulin resistance and endothelial function. Int J Clin Pract. 2014 Feb;68(2):271-7. doi: 10.1111/ijcp.12310. Epub 2013 Dec 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00898950
2004-001418-14
No
Dr MH Cummings, Portsmouth Hospitals NHS Trust & University of Portsmouth
University of Portsmouth
Not Provided
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
University of Portsmouth
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP