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

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ClinicalTrials.gov Identifier: NCT00263419
Recruitment Status : Unknown
Verified October 2011 by Stefan Kopf MD, Heidelberg University.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2005
Last Update Posted : October 27, 2011
Sponsor:
Information provided by (Responsible Party):
Stefan Kopf MD, Heidelberg University

Brief Summary:
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 or disease Intervention/treatment Phase
Albuminuria Diabetes Mellitus, Type 2 Diabetes Complications Behavioral: Mindfulness Based Stress Reduction Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
Study Start Date : January 2005
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Progression of albuminuria [ Time Frame: 1,2,3,4 and 5 year ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 3,4 and 5 years ]
  2. Late diabetic complications (micro-macrovascular) [ Time Frame: 1,2,3,4 and 5 years ]
  3. Cardiovascular Events [ Time Frame: 1, 2,3,4 and 5 years ]
  4. Nuclear Factor kappa B as marker of psychosocial stress [ Time Frame: 1,2,3,4 and 5 years ]
  5. Quality of life [ Time Frame: post intervention, 1,2,3,4 and 5 years ]
  6. Psychological symptoms [ Time Frame: post intervention, 1,2,3,4 and 5 years ]
  7. Cardiovascular risk factors [ Time Frame: post intervention, 1,2,3,4 and 4 years ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263419


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefan Kopf MD, Prof. P.P. Nawroth & Dr. med S. Kopf, Heidelberg University
ClinicalTrials.gov Identifier: NCT00263419     History of Changes
Other Study ID Numbers: HD-Med1-01/05
First Posted: December 8, 2005    Key Record Dates
Last Update Posted: October 27, 2011
Last Verified: October 2011

Keywords provided by Stefan Kopf MD, Heidelberg University:
Diabetes Type 2
Late Complications
Stress relief management
psychosocial stress

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Albuminuria
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms