Stress-Relief Management for Treatment of Late Complications in Type 2 Diabetes - Full Text View

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00263419

Purpose

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
Albuminuria Diabetes Mellitus, Type 2 Diabetes Complications	Behavioral: Mindfulness Based Stress Reduction

MedlinePlus related topics: Diabetes Diabetes Complications

U.S. FDA Resources

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

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Progression of albuminuria

Secondary Outcome Measures:

Mortality
Late diabetic complications (micro-macrovascular)
Cardiovascular Events
Nuclear Factor kappa B as marker of psychosocial stress
Quality of life
Psychological symptoms
Cardiovascular risk factors

Estimated Enrollment:	440
Study Start Date:	January 2005
Estimated Study Completion Date:	June 2011

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.

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263419

Locations

Germany
Department of Medicine, University of Heidelberg
Heidelberg, Germany, 69120

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:

Peter P Nawroth, MD

University of Heidelberg, Dept. Medicine 1, Germany

More Information

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

Keywords provided by University of Heidelberg:

Diabetes Type 2
Late Complications
Stress relief management
psychosocial stress

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009