Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Progression of albuminuria
研究概览
简要总结
The purpose of this study is to determine whether a structured stress relief management program can prevent the progression of late diabetic complications in patients with type 2 diabetes.
详细描述
Patients with type 2 diabetes and increased albumin excretion have an increased risk of renal failure and cardiovascular events. It has recently been shown, that psychosocial stress is an additional major risk factor contributing to the increased risk of cardiac events. However, it is not clear, whether a structured stress-relief training of patients reduces the risk of micro- and macrovascular damage in type 2 diabetes.
Comparisons: Conventional treatment of diabetes according to national guidelines is compared to conventional treatment plus structured stress relief management training.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Type 2
- •Albuminuria
- •Age 30-70
排除标准
- •Diabetes duration < 3 years
- •Preexisting non-diabetic kidney
- •Psychiatric disorders
- •Alcohol or drug abuse
- •Malignant tumors or hematologic disorders
- •Heart failure NYHA III-IV
- •Acute coronary syndrome
结局指标
主要结局
Progression of albuminuria
时间窗: 1,2,3,4 and 5 year
次要结局
- Mortality(3,4 and 5 years)
- Late diabetic complications (micro-macrovascular)(1,2,3,4 and 5 years)
- Cardiovascular Events(1, 2,3,4 and 5 years)
- Nuclear Factor kappa B as marker of psychosocial stress(1,2,3,4 and 5 years)
- Quality of life(post intervention, 1,2,3,4 and 5 years)
- Psychological symptoms(post intervention, 1,2,3,4 and 5 years)
- Cardiovascular risk factors(post intervention, 1,2,3,4 and 4 years)
研究者
Stefan Kopf MD
Prof. P.P. Nawroth & Dr. med S. Kopf
Heidelberg University