NCT01053234已完成不适用
Effects of Standardised Meals on Postprandial Coagulation Activation in Patients With Type 2 Diabetes Treated With Two Different Insulin Regimens
Esbjerg Hospital - University Hospital of Southern Denmark2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2007年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Prothrombin fragment 1+2
研究概览
简要总结
The purpose of this study in patients with type 2 diabetes was to investigate the acute effect of postprandial blood glucose levels modified by two different insulin treatment regimens on coagulation activation, inflammation and endothelial cell function. The investigators hypothesized that the rapid-acting insulin analogue aspart has a beneficial postprandial effect on coagulation, endothelial dysfunction and inflammation compared with the intermediate-acting insulin NPH due to its ability to lower postprandial glycaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 30-75 years
- •BMI > 25 kg/m2
- •type 2 diabetes for more than 4 years
- •pharmacological anti-diabetic treatment with insulin NPH at bedtime or insulin aspart at meals for more than 24 months
- •metformin with stable dose >1000 mg/d for more than 12 weeks
- •acetylsalicylic acid (75 mg/d) for more than 2 weeks
- •no other anti-diabetic treatment 3 month previously
- •HbA1c<8.5% at recruitment.
排除标准
- •creatinine > 120 µmol/l
- •ALAT /ASAT > 2.5 x upper reference limit
- •use of anticoagulants within 1 month previously
- •any changes in dose of statins within 1 month previously
- •night work
- •present or planned pregnancy
- •mental sickness or alcohol abuse
- •clinically relevant major organ or systemic illness
- •uncontrolled hypertension >180/110 mmHg
- •steroid treatment
- •known or suspected allergy to trial medications.
结局指标
主要结局
Prothrombin fragment 1+2
时间窗: 7.40; 9.30; 11.30; 13.30; 15.30
次要结局
- C-reactive protein(7.40; 9.30; 11.30; 13.30; 15.30)
研究者
研究点 (2)
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