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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
8 weeks mindfulness based stress reduction (MBSR) based on body and meditation practices that aims at cultivation of openness, awareness of the present moment and acceptance of all internal and external experiences. It is assumed that this allows to act more reflectively rather than impulsively.
Department of Medicine, University of Heidelberg
Heidelberg, Germany
Progression of albuminuria
Time frame: 1,2,3,4 and 5 year
Mortality
Time frame: 3,4 and 5 years
Late diabetic complications (micro-macrovascular)
Time frame: 1,2,3,4 and 5 years
Cardiovascular Events
Time frame: 1, 2,3,4 and 5 years
Nuclear Factor kappa B as marker of psychosocial stress
Time frame: 1,2,3,4 and 5 years
Quality of life
Time frame: post intervention, 1,2,3,4 and 5 years
Psychological symptoms
Time frame: post intervention, 1,2,3,4 and 5 years
Cardiovascular risk factors
Time frame: post intervention, 1,2,3,4 and 4 years
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