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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Type 2

Intervention / Treatment
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* Drug: Aspirin
* Drug: Aspirin
* Drug: Aspirin
* Other: placebo tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin low dose<br>Effects of using aspirin 75 mgs/day for 2 weeks. | Drug: Aspirin<br>* Aspirin 75mgs/day orally for 2 weeks.<br>* Other names: acetyl salicylic acid;|
| Experimental: Aspirin medium dose<br>Effects of using aspirin 300 mgs/day | Drug: Aspirin<br>* 300mgs/day orally for 2 weeks<br>* Other names: acetyl salicylic acid;|
| Experimental: aspirin high dose<br>aspirin 900mgs QID orally for 2 weeks | Drug: Aspirin<br>* aspirin 900mgs QID orally for 2 weeks<br>* Other names: acetyl salicylic acid;|
| Placebo Comparator: placebo<br> | Other: placebo tablet<br>* placebo tablet with lactose and excipients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammatory markers |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, aspirin, oxidative stress, insulin resistance, endothelial function, inflammation, photoplethysmography, dysglycaemia