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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Heidelberg University.
Recruitment status was  Active, not recruiting
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
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
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:

Further study details as provided by Heidelberg University:

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:
    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
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.


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

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
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Please refer to this study by its identifier: NCT00263419

Department of Medicine, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Peter P Nawroth, MD University of Heidelberg, Dept. Medicine 1, Germany
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stefan Kopf MD, Prof. P.P. Nawroth & Dr. med S. Kopf, University of Heidelberg 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 Heidelberg University:
Diabetes Type 2
Late Complications
Stress relief management
psychosocial stress

Additional relevant MeSH terms:
Diabetes Complications
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations processed this record on May 26, 2016