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

Diabetes Mellitus, Type 2 Clinical Trial

— HEIDIS  

Official title:

Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00263419
• Other study ID #: HD-Med1-01/05
• Status: Active, not recruiting
• Phase: N/A
• First received: December 7, 2005
• Last updated: October 26, 2011
• Start date: January 2005
• Est. completion date: June 2012

Study information

• Verified date: October 2011
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Regierungspräsidium Karlsruhe
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: June 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Medicine, University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of albuminuria		1,2,3,4 and 5 year	No
Secondary	Mortality		3,4 and 5 years	No
Secondary	Late diabetic complications (micro-macrovascular)		1,2,3,4 and 5 years	No
Secondary	Cardiovascular Events		1, 2,3,4 and 5 years	No
Secondary	Nuclear Factor kappa B as marker of psychosocial stress		1,2,3,4 and 5 years	No
Secondary	Quality of life		post intervention, 1,2,3,4 and 5 years	No
Secondary	Psychological symptoms		post intervention, 1,2,3,4 and 5 years	No
Secondary	Cardiovascular risk factors		post intervention, 1,2,3,4 and 4 years	No