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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Stefan Kopf MD, University of Heidelberg

ClinicalTrials.gov Identifier:

NCT00263419

First received: December 7, 2005

Last updated: October 26, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 7, 2005

Last Updated Date

October 26, 2011

Start Date ^ICMJE

January 2005

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Progression of albuminuria

Change History

Complete list of historical versions of study NCT00263419 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2

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.

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 ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Albuminuria
Diabetes Mellitus, Type 2
Diabetes Complications

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Hartmann M, Kopf S, Kircher C, Faude-Lang V, Djuric Z, Augstein F, Friederich HC, Kieser M, Bierhaus A, Humpert PM, Herzog W, Nawroth PP. Sustained effects of a mindfulness-based stress-reduction intervention in type 2 diabetic patients: design and first results of a randomized controlled trial (the Heidelberger Diabetes and Stress-study). Diabetes Care. 2012 May;35(5):945-7. Epub 2012 Feb 14.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

110

Estimated Completion Date

June 2012

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

30 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00263419

Other Study ID Numbers ^ICMJE

HD-Med1-01/05

Has Data Monitoring Committee

Not Provided

Responsible Party

Stefan Kopf MD, University of Heidelberg

Study Sponsor ^ICMJE

University of Heidelberg

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Peter P Nawroth, MD

University of Heidelberg, Dept. Medicine 1, Germany

Information Provided By

University of Heidelberg

Verification Date

October 2011

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

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