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

Sponsor:	University of Heidelberg
Information provided by (Responsible Party):	Stefan Kopf MD, 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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Complications Diabetes Type 2

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Progression of albuminuria [ Time Frame: 1,2,3,4 and 5 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mortality [ Time Frame: 3,4 and 5 years ] [ Designated as safety issue: No ]
Late diabetic complications (micro-macrovascular) [ Time Frame: 1,2,3,4 and 5 years ] [ Designated as safety issue: No ]
Cardiovascular Events [ Time Frame: 1, 2,3,4 and 5 years ] [ Designated as safety issue: No ]
Nuclear Factor kappa B as marker of psychosocial stress [ Time Frame: 1,2,3,4 and 5 years ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: post intervention, 1,2,3,4 and 5 years ] [ Designated as safety issue: No ]
Psychological symptoms [ Time Frame: post intervention, 1,2,3,4 and 5 years ] [ Designated as safety issue: No ]
Cardiovascular risk factors [ Time Frame: post intervention, 1,2,3,4 and 4 years ] [ Designated as safety issue: No ]

Enrollment:	110
Study Start Date:	January 2005
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Other Name: Heidelberger Diabetes and Stress (HEIDIS) - Study

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

No publications provided

Responsible Party:	Stefan Kopf MD, Prof. P.P. Nawroth & Dr. med S. Kopf, University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00263419 History of Changes
Other Study ID Numbers:	HD-Med1-01/05
Study First Received:	December 7, 2005
Last Updated:	October 26, 2011
Health Authority:	Germany: Regierungspräsidium Karlsruhe

Keywords provided by University of Heidelberg:

Diabetes Type 2
Late Complications
Stress relief management
psychosocial stress

Additional relevant MeSH terms:

Albuminuria
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
Proteinuria
Urination Disorders

Urologic Diseases
Urological Manifestations
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012