Stockholm Diabetes Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Cardiovascular Mortality
研究概览
简要总结
To investigate long-term effects on cardiovascular mortality/morbidity and renal failure in type 1 diabetes patients former randomized to intensive insulin treatment
详细描述
The Stockholm Diabetes Intervention Study (SDIS) aimed to determine whether intensified insulin treatment were feasible and led to less serious diabetic complications. 102 patients with type 1 diabetes mellitus were randomized (October 1982 to March 1984) to intensified conventional treatment (ICT; n=48) or standard treatment (ST; n=54). The randomized SDIS study lasted for 7.5 years, whereas 96 patients were fully evaluated. Thereafter patients were assigned to their regular clinical visits.
In the present interventional study we wanted to study all-cause mortality and cardiovascular outcomes (i.e. myocardial infarction and stroke), and renal failure in the SDIS cohort until december 31 2011.
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
- 18 Years 至 52 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born 1930 or later
- •Type 1 diabetes
- •Nonproliferative retinopathy
- •Normal serum creatinine
- •Unsatisfactory blood glucose control
排除标准
- •Alcohol/drug abuse
- •Proliferative retinopathy
研究组 & 干预措施
Intensive insulin treatment
Intensive insulin treatment
干预措施: Intensive insulin treatment (Drug)
Standard insulin treatment
Standard insulin treatment
干预措施: Standard insulin treatment (Drug)
结局指标
主要结局
Cardiovascular Mortality
时间窗: Up to 28 years
All cause mortality and composite mortality from myocardial infarction, stroke and renal failure
次要结局
- Morbidity of Cardiovascular Complications(Up to 28 years)
研究者
Thomas Nystrom
dr
Karolinska Institutet