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

NCT ID: NCT00263419

Last Updated: 2011-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Albuminuria Diabetes Mellitus, Type 2 Diabetes Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Heidelberger Diabetes and Stress (HEIDIS) - Study

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Stefan Kopf MD

Prof. P.P. Nawroth & Dr. med S. Kopf

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter P Nawroth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Heidelberg, Dept. Medicine 1, Germany

Locations

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Department of Medicine, University of Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 39171639 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24798861 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24366425 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22338101 (View on PubMed)

Other Identifiers

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HD-Med1-01/05

Identifier Type: -

Identifier Source: org_study_id