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Completed

NCT Number: NCT00898950

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

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.

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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, Hampshire, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

Aspirin 75mgs/day orally for 2 weeks.

Other names: acetyl salicylic acid

Placebo tablet

Other

placebo tablet with lactose and excipients.

Primary outcomes

  1. Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance

    Time frame: 2 weeks

Secondary outcomes

  1. Change in inflammatory markers

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

University of Portsmouth

Other

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
May 12, 2009
Registry last updated
May 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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