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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin low dose | Experimental | Effects of using aspirin 75 mgs/day for 2 weeks. |
|
| Aspirin medium dose | Experimental | Effects of using aspirin 300 mgs/day |
|
| aspirin high dose | Experimental | aspirin 900mgs QID orally for 2 weeks |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Aspirin 75mgs/day orally for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory markers | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajeev P Raghavan, MBBS, MRCP | Portsmouth Hospitals NHS Trust | Principal Investigator |
| Michael H Cummings, MD, FRCP | Portsmouth Hospitals NHS TRust & University of Portsmouth | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Pharmacy and Biomedical Sciences, University of Posrtmouth | Portsmouth | Hampshire | PO1 2DT | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24372992 | Derived | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007333 | Insulin Resistance |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Aspirin | Drug | 300mgs/day orally for 2 weeks |
|
|
| Aspirin | Drug | aspirin 900mgs QID orally for 2 weeks |
|
|
| placebo tablet | Other | placebo tablet with lactose and excipients. |
|
| Diabetes Centre, Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust |
| Portsmouth |
| Hampshire |
| PO6 3LY |
| United Kingdom |
| D006946 | Hyperinsulinism |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |