NCT00263419

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2005

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 27, 2011

Status Verified

October 1, 2011

Enrollment Period

7.2 years

First QC Date

December 7, 2005

Last Update Submit

October 26, 2011

Conditions

AlbuminuriaDiabetes Mellitus, Type 2Diabetes Complications

Keywords

Diabetes Type 2Late ComplicationsStress relief managementpsychosocial stress

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

Mindfulness Based Stress ReductionBEHAVIORAL

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.

Also known as: Heidelberger Diabetes and Stress (HEIDIS) - Study

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Department of Medicine, University of Heidelberg

Heidelberg, 69120, Germany

Location

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: 39171639DERIVED

  • 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.

    PMID: 24798861DERIVED

  • 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.

    PMID: 24366425DERIVED

  • 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.

    PMID: 22338101DERIVED

MeSH Terms

Conditions

AlbuminuriaDiabetes Mellitus, Type 2Diabetes Complications

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

ProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Peter P Nawroth, MD

    University of Heidelberg, Dept. Medicine 1, Germany

    PRINCIPAL INVESTIGATOR

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 1, 2005

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

October 27, 2011

Record last verified: 2011-10

Locations

DE(1)