Albuminuria, Diabetes Complications, Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Type 2, Late Complications, Stress relief management, psychosocial stress
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMindfulness Based Stress Reduction
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.
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of albuminuria | 1,2,3,4 and 5 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed