Stress-relief Management for Treatment of Late Complications in Type 2 Diabetes
HEIDIS
Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
Other study identifiers
Sponsor study identifier
interventional
110
1 country
1
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- unknown
- Actual enrollment (reported)
- 110 participants
- Study completion date
June 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Listed locations
- 1 countries · 1 sites
Trial Relationships
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
First Submitted
December 7, 2005
Actual (reported)First Posted
December 8, 2005
Actual (reported)Primary Completion
March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Last Updated
- October 27, 2011
- Status Verified
- October 2011
- Last Update Submitted
- October 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression of albuminuria
1,2,3,4 and 5 year
Secondary Outcomes (7)
Mortality
3,4 and 5 years
Late diabetic complications (micro-macrovascular)
1,2,3,4 and 5 years
Cardiovascular Events
1, 2,3,4 and 5 years
Nuclear Factor kappa B as marker of psychosocial stress
1,2,3,4 and 5 years
Quality of life
post intervention, 1,2,3,4 and 5 years
- +2 more secondary outcomes
Interventions
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
You may qualify if:
- Diabetes Type 2
- Albuminuria
- Age 30-70
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heidelberg UniversityOtherlead
Study Sites (1)
Department of Medicine, University of Heidelberg
Heidelberg, 69120, Germany
Related Publications (4)
Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
PMID: 39171639DERIVEDKopf 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.
PMID: 24798861DERIVEDKopf 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.
PMID: 24366425DERIVEDHartmann 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.
PMID: 22338101DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter P Nawroth, MD
University of Heidelberg, Dept. Medicine 1, Germany
Enrollment
110 participants (actual enrollment reported by the registry).
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. P.P. Nawroth & Dr. med S. Kopf
Study Record Dates
First Submitted
December 7, 2005
First Posted
December 8, 2005
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 27, 2011
Record last verified: 2011-10
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
- Registry identifier
- NCT00263419
- Data provider
- ClinicalTrials.gov
- Source updated
- 2011-10-27
- Normalization version
- ctgov-legacy-1
Source retrieved: