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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diabetes type 2
- •age > 18 and < 70
- •high cardiovascular risk
排除标准
- •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
研究组 & 干预措施
placebo
干预措施: placebo tablet (Other)
Aspirin low dose
Effects of using aspirin 75 mgs/day for 2 weeks.
干预措施: Aspirin (Drug)
Aspirin medium dose
Effects of using aspirin 300 mgs/day
干预措施: Aspirin (Drug)
aspirin high dose
aspirin 900mgs QID orally for 2 weeks
干预措施: Aspirin (Drug)
结局指标
主要结局
Change in markers of oxidative stress, endothelial function, glycaemic control, and insulin resistance
时间窗: 2 weeks
次要结局
- Change in inflammatory markers(2 weeks)