Stress-relief Management for Treatment of Late Complications in Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2

Conditions
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Albuminuria, Diabetes Mellitus, Type 2, Diabetes Complications

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Mindfulness 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of albuminuria |  | 1,2,3,4 and 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Type 2, Late Complications, Stress relief management, psychosocial stress