Stress-relief Management for Treatment of Late Complications in Type 2 Diabetes (HEIDIS)
Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Heidelberg、德国、69120
- Department of Medicine, University of Heidelberg
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diabetes Type 2
- Albuminuria
- Age 30-70
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Progression of albuminuria
大体时间:1,2,3,4 and 5 year
|
1,2,3,4 and 5 year
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Mortality
大体时间:3,4 and 5 years
|
3,4 and 5 years
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Late diabetic complications (micro-macrovascular)
大体时间:1,2,3,4 and 5 years
|
1,2,3,4 and 5 years
|
Cardiovascular Events
大体时间:1, 2,3,4 and 5 years
|
1, 2,3,4 and 5 years
|
Nuclear Factor kappa B as marker of psychosocial stress
大体时间:1,2,3,4 and 5 years
|
1,2,3,4 and 5 years
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Quality of life
大体时间:post intervention, 1,2,3,4 and 5 years
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post intervention, 1,2,3,4 and 5 years
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Psychological symptoms
大体时间:post intervention, 1,2,3,4 and 5 years
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post intervention, 1,2,3,4 and 5 years
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Cardiovascular risk factors
大体时间:post intervention, 1,2,3,4 and 4 years
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post intervention, 1,2,3,4 and 4 years
|
合作者和调查者
调查人员
- 首席研究员:Peter P Nawroth, MD、University of Heidelberg, Dept. Medicine 1, Germany
出版物和有用的链接
一般刊物
- Kopf S, Oikonomou D, Hartmann M, Feier F, Faude-Lang V, Morcos M, Haring HU, Herzog W, Bierhaus A, Humpert PM, Nawroth PP. Effects of stress reduction on cardiovascular risk factors in type 2 diabetes patients with early kidney disease - results of a randomized controlled trial (HEIDIS). Exp Clin Endocrinol Diabetes. 2014 Jun;122(6):341-9. doi: 10.1055/s-0034-1372583. Epub 2014 May 5.
- Kopf S, Oikonomou D, von Eynatten M, Kieser M, Zdunek D, Hess G, Morcos M, Forsblom C, Bierhaus A, Groop PH, Nawroth PP, Humpert PM. Urinary excretion of high molecular weight adiponectin is an independent predictor of decline of renal function in type 2 diabetes. Acta Diabetol. 2014;51(3):479-89. doi: 10.1007/s00592-013-0542-2. Epub 2013 Dec 24.
- Hartmann M, Kopf S, Kircher C, Faude-Lang V, Djuric Z, Augstein F, Friederich HC, Kieser M, Bierhaus A, Humpert PM, Herzog W, Nawroth PP. Sustained effects of a mindfulness-based stress-reduction intervention in type 2 diabetic patients: design and first results of a randomized controlled trial (the Heidelberger Diabetes and Stress-study). Diabetes Care. 2012 May;35(5):945-7. doi: 10.2337/dc11-1343. Epub 2012 Feb 14.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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