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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Stefan Kopf MD, University of Heidelberg Identifier:
First received: December 7, 2005
Last updated: October 26, 2011
Last verified: October 2011

December 7, 2005
October 26, 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 ] [ Designated as safety issue: No ]
Progression of albuminuria
Complete list of historical versions of study NCT00263419 on Archive Site
  • 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 ]
  • 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
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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 Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
Active, not recruiting
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
30 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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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