Intensified Multifactorial Intervention in Patients With Type 2 Diabetes and Microalbuminuria
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Diabetic nephropathy
研究概览
简要总结
The purpose of this study is to determine whether intensified multifactorial intervention comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic complications compared to standard treatment in patients with type 2 diabetes and microalbuminuria.
详细描述
The overall description of the Steno-2 Study is stated in four protocols approved by the regulatory authorities in Denmark. The protocol identification numbers are KA 92071gm (4 years intervention ), KA-99035g (8 years intervention ), KA-99035-GS (13 years follow-up since intervention start) and H-KA-99035-GS (21 year follow-up since intervention start).
The aim of the study was to determine whether intensified multifactorial intervention comprising both behaviour modification and polypharmacy can reduce the risk for late diabetic complications compared to standard treatment in patients with type 2 diabetes and microalbuminuria. The primary end point after four years of intervention was to progression to diabetic nephropathy with other microvascular complications as secondary end points. The primary end point after eight years of intervention was a composite CVD endpoint with microvascular complications as secondary end points.
The interventional part of the study was ended in December 2001 after a total of eight years of intervention. From that time on, all patients were followed in a post-trial study. Also, during post-trial period all patients in both original treatment arms received similar treatment resembling the treatment given in the original intensive arm of the study. The aim of the post-trial follow-up was to investigate the effect of intensified multifactorial intervention on i) mortality and ii) years of life gained, respectively, with such an interventional approach.
Endpoints in the two parts of the post-trial follow-up:
Part one at 13 years since start of intervention:
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •Microalbuminuria
排除标准
- •Stimulated serum C-peptide concentration less than 600 pmol/L
- •Pancreatic insufficiency or diabetes secondary to pancreatitis
- •Alcohol abuse
- •Non-diabetic kidney disease
- •Life-threatening disease with death probable within 4 years of study start
研究组 & 干预措施
Standard Treatment Arm
This arm will at any time during the active intervention period follow treatment guidelines by the Danish Medical Association for the treatment of type 2 diabetes.
干预措施: Diet (Behavioral)
Standard Treatment Arm
This arm will at any time during the active intervention period follow treatment guidelines by the Danish Medical Association for the treatment of type 2 diabetes.
干预措施: Exercise (Behavioral)
Standard Treatment Arm
This arm will at any time during the active intervention period follow treatment guidelines by the Danish Medical Association for the treatment of type 2 diabetes.
干预措施: Stop smoking (Behavioral)
Standard Treatment Arm
This arm will at any time during the active intervention period follow treatment guidelines by the Danish Medical Association for the treatment of type 2 diabetes.
干预措施: Glucose lowering therapy (Drug)
Standard Treatment Arm
This arm will at any time during the active intervention period follow treatment guidelines by the Danish Medical Association for the treatment of type 2 diabetes.
干预措施: Blood pressure lowering therapy (Drug)
Standard Treatment Arm
This arm will at any time during the active intervention period follow treatment guidelines by the Danish Medical Association for the treatment of type 2 diabetes.
干预措施: Lipid lowering therapy (Drug)
Intensive Treatment Arm
This arm will during the active intervention period be treated according to intensified multiple risk factor intervention following strict guidelines set out by the study protocol.
干预措施: Diet (Behavioral)
Intensive Treatment Arm
This arm will during the active intervention period be treated according to intensified multiple risk factor intervention following strict guidelines set out by the study protocol.
干预措施: Exercise (Behavioral)
Intensive Treatment Arm
This arm will during the active intervention period be treated according to intensified multiple risk factor intervention following strict guidelines set out by the study protocol.
干预措施: Stop smoking (Behavioral)
Intensive Treatment Arm
This arm will during the active intervention period be treated according to intensified multiple risk factor intervention following strict guidelines set out by the study protocol.
干预措施: Glucose lowering therapy (Drug)
Intensive Treatment Arm
This arm will during the active intervention period be treated according to intensified multiple risk factor intervention following strict guidelines set out by the study protocol.
干预措施: Blood pressure lowering therapy (Drug)
Intensive Treatment Arm
This arm will during the active intervention period be treated according to intensified multiple risk factor intervention following strict guidelines set out by the study protocol.
干预措施: Lipid lowering therapy (Drug)
结局指标
主要结局
Diabetic nephropathy
时间窗: Four years
Combined cardiovascular endpoint
时间窗: Eight years
Total mortality
时间窗: 13 years
Years of life years gained
时间窗: 21 years
次要结局
- All cause mortality(22 years)
- Cardiovascular disease mortality(22 years)
- Stroke(22 years)
- Myocardial infarction(22 years)
- Coronary interventions(22 years)
- Amputations(22 years)
- Vascular surgery(22 years)
- Diabetic retinopathy(22 years)
- Diabetic nephropathy(22 years)
- Diabetic neuropathy(22 years)
研究者
Peter Gæde
Associate Professor
Steno Diabetes Center Copenhagen