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Sponsored by: |
University of Heidelberg |
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Information provided by: | University of Heidelberg |
ClinicalTrials.gov Identifier: | NCT00263419 |
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.
Condition | Intervention |
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Albuminuria Diabetes Mellitus, Type 2 Diabetes Complications |
Behavioral: Mindfulness Based Stress Reduction |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2 |
Estimated Enrollment: | 440 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | June 2011 |
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.
Ages Eligible for Study: | 30 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Department of Medicine, University of Heidelberg | |
Heidelberg, Germany, 69120 |
Principal Investigator: | Peter P Nawroth, MD | University of Heidelberg, Dept. Medicine 1, Germany |
Study ID Numbers: | HD-Med1-01/05 |
Study First Received: | December 7, 2005 |
Last Updated: | February 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00263419 |
Health Authority: | Germany: Regierungspräsidium Karlsruhe |
Diabetes Type 2 Late Complications Stress relief management psychosocial stress |
Albuminuria Metabolic Diseases Urination Disorders Diabetes Mellitus Stress Endocrine System Diseases Signs and Symptoms |
Proteinuria Urologic Diseases Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Diabetes Complications |
Urological Manifestations |