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

Primary Purpose

Albuminuria, Diabetes Mellitus, Type 2, Diabetes Complications

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction
Sponsored by
Heidelberg University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Albuminuria focused on measuring Diabetes Type 2, Late Complications, Stress relief management, psychosocial stress

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medicine, University of Heidelberg

Outcomes

Primary Outcome Measures

Progression of albuminuria

Secondary Outcome Measures

Mortality
Late diabetic complications (micro-macrovascular)
Cardiovascular Events
Nuclear Factor kappa B as marker of psychosocial stress
Quality of life
Psychological symptoms
Cardiovascular risk factors

Full Information

First Posted
December 7, 2005
Last Updated
October 26, 2011
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT00263419
Brief Title
Stress-relief Management for Treatment of Late Complications in Type 2 Diabetes
Acronym
HEIDIS
Official Title
Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Albuminuria, Diabetes Mellitus, Type 2, Diabetes Complications
Keywords
Diabetes Type 2, Late Complications, Stress relief management, psychosocial stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction
Other Intervention Name(s)
Heidelberger Diabetes and Stress (HEIDIS) - Study
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression of albuminuria
Time Frame
1,2,3,4 and 5 year
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
3,4 and 5 years
Title
Late diabetic complications (micro-macrovascular)
Time Frame
1,2,3,4 and 5 years
Title
Cardiovascular Events
Time Frame
1, 2,3,4 and 5 years
Title
Nuclear Factor kappa B as marker of psychosocial stress
Time Frame
1,2,3,4 and 5 years
Title
Quality of life
Time Frame
post intervention, 1,2,3,4 and 5 years
Title
Psychological symptoms
Time Frame
post intervention, 1,2,3,4 and 5 years
Title
Cardiovascular risk factors
Time Frame
post intervention, 1,2,3,4 and 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter P Nawroth, MD
Organizational Affiliation
University of Heidelberg, Dept. Medicine 1, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24798861
Citation
Kopf S, Oikonomou D, Hartmann M, Feier F, Faude-Lang V, Morcos M, Haring HU, Herzog W, Bierhaus A, Humpert PM, Nawroth PP. Effects of stress reduction on cardiovascular risk factors in type 2 diabetes patients with early kidney disease - results of a randomized controlled trial (HEIDIS). Exp Clin Endocrinol Diabetes. 2014 Jun;122(6):341-9. doi: 10.1055/s-0034-1372583. Epub 2014 May 5.
Results Reference
derived
PubMed Identifier
24366425
Citation
Kopf S, Oikonomou D, von Eynatten M, Kieser M, Zdunek D, Hess G, Morcos M, Forsblom C, Bierhaus A, Groop PH, Nawroth PP, Humpert PM. Urinary excretion of high molecular weight adiponectin is an independent predictor of decline of renal function in type 2 diabetes. Acta Diabetol. 2014;51(3):479-89. doi: 10.1007/s00592-013-0542-2. Epub 2013 Dec 24.
Results Reference
derived
PubMed Identifier
22338101
Citation
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. doi: 10.2337/dc11-1343. Epub 2012 Feb 14.
Results Reference
derived

Learn more about this trial

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

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