Diabetes Type 2
Conditions
Keywords
diabetes, aspirin, oxidative stress, insulin resistance, endothelial function, inflammation, photoplethysmography, dysglycaemia
Brief summary
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.
Interventions
DRUGAspirin
Aspirin 75mgs/day orally for 2 weeks.
OTHERplacebo tablet
placebo tablet with lactose and excipients.
Sponsors
University of Portsmouth
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in inflammatory markers | 2 weeks |
Countries
United Kingdom
Outcome results
None listed