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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00263419
Recruitment Status : Unknown
Verified October 2011 by Stefan Kopf MD, University of Heidelberg.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2005
Last Update Posted : October 27, 2011
Information provided by (Responsible Party):
Stefan Kopf MD, University of Heidelberg

December 7, 2005
December 8, 2005
October 27, 2011
January 2005
March 2012   (Final data collection date for primary outcome measure)
Progression of albuminuria [ Time Frame: 1,2,3,4 and 5 year ]
Progression of albuminuria
Complete list of historical versions of study NCT00263419 on Archive Site
  • Mortality [ Time Frame: 3,4 and 5 years ]
  • Late diabetic complications (micro-macrovascular) [ Time Frame: 1,2,3,4 and 5 years ]
  • Cardiovascular Events [ Time Frame: 1, 2,3,4 and 5 years ]
  • Nuclear Factor kappa B as marker of psychosocial stress [ Time Frame: 1,2,3,4 and 5 years ]
  • Quality of life [ Time Frame: post intervention, 1,2,3,4 and 5 years ]
  • Psychological symptoms [ Time Frame: post intervention, 1,2,3,4 and 5 years ]
  • Cardiovascular risk factors [ Time Frame: post intervention, 1,2,3,4 and 4 years ]
  • Mortality
  • Late diabetic complications (micro-macrovascular)
  • Cardiovascular Events
  • Nuclear Factor kappa B as marker of psychosocial stress
  • Quality of life
  • Psycholigical symptoms
  • Cardiovascular risk factors
Not Provided
Not Provided
Stress-relief Management for Treatment of Late Complications in Type 2 Diabetes
Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Albuminuria
  • Diabetes Mellitus, Type 2
  • Diabetes Complications
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.
Other Name: Heidelberger Diabetes and Stress (HEIDIS) - Study
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
June 2012
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
30 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Stefan Kopf MD, University of Heidelberg
Heidelberg University
Not Provided
Principal Investigator: Peter P Nawroth, MD University of Heidelberg, Dept. Medicine 1, Germany
Heidelberg University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP