The ADDITION Study. Anglo-Danish-Dutch Study of Intensive Treatment In PeOple With screeN Detected Diabetes in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,057
- 试验地点
- 6
- 主要终点
- Stroke (non fatal)
研究概览
简要总结
The ADDITION study comprise 2 parts: screening for Type 2 diabetes and intensive treatment compared to standard treatment.
- In the screening study, the feasibility and results of country specific models to identify undiagnosed individuals with Type 2 diabetes will be evaluated.
- In the treatment study the effects of routine care in general practice according to local and national guidelines will be compared with an intensive ADDITION protocol, including structured lifestyle education (dietary modification, increased physical activity and smoking cessation) and intensive treatment of blood glucose, blood pressure and lipids, and prophylactic aspirin with or without motivational interviewing, on mortality, macrovascular and microvascular disease. Furthermore the impact of treatment on health status, treatment satisfaction and health service costs will also be assessed.
详细描述
Aims:
- To develop and evaluate strategies for early detection of type 2 diabetes in different countries and different populations.
- To study whether a multifactorial treatment strategy can reduce CVD-mortality and reduce the incidence of macro- and microvascular complications. The treatment strategy consists of motivational interviewing, encouraging behavioural changes (dietary advises, physical activity, smoking cessation) and intensive pharmacological treatment of blood pressure, blood glucose, and serum lipids
- To identify genetic markers predicting development of diabetic complications
- To evaluate health economical consequences of screening and early intervention for type 2 diabetes
Design and methods:
The study is an investigator initiated and designed study, initiated in Denmark by the two principal investigators, planned and conducted in collaboration between the four centers in Denmark, UK and the Netherlands. The study has two elements: a screening study and a subsequent intervention study.
In the screening study, the feasibility and results of country specific models to identify undiagnosed individuals with Type 2 diabetes will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screening study: Every one aged 40-69 years (UK and DK) or 50-69 years(NL). Treatment study: All with screen detected type 2 diabetes.
排除标准
- •Participants are excluded if they already have diabetes at time of screening, are pregnant or lactating or have a severe psychotic illness, are house bound or have an illness with a likely survival of less than one year.
研究组 & 干预措施
Intervention
The 334 general practices in Denmark, United Kingdom and the Netherlands have been randomised to screening for diabetes followed by routine care (RC group) according to national guidelines, or screening followed by multifactorial treatment (IT group).
干预措施: optimised treatment (Procedure)
结局指标
主要结局
Stroke (non fatal)
时间窗: Sept 2010
MI (non fatal)
时间窗: Sept 2010
Cardiovascular mortality
时间窗: Sept 2010
Revascularisation (operating procedures)
时间窗: Sept 2010
Amputations, non traumatic
时间窗: Sept 2010
次要结局
- Perceived health, SF36, AddQol(2010)
- Progression of retinopathy(2010)
- Neuropathy, periphery and autonomy(2011)
- Development of renal impairment(2010)
- All cause mortality(2010)
- Health economy, patient and health service costs and gains(2010)