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

Not Applicable

• Conditions: Albuminuria; Diabetes Mellitus, Type 2; Diabetes Complications

• Registration Number: NCT00263419
• Lead Sponsor: Heidelberg University

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-12-07
• Study First Submitted QC: 2005-12-07
• Study First Posted: 2005-12-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-26
• Last Update Posted: 2011-10-27
• Primary Completion: 2012-03
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression of albuminuria	1,2,3,4 and 5 year

Secondary Outcome Measures

Name	Time	Method
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
Psychological symptoms	post intervention, 1,2,3,4 and 5 years
Cardiovascular risk factors	post intervention, 1,2,3,4 and 4 years

Trial Locations

Locations (1)

Department of Medicine, University of Heidelberg; 🇩🇪 Heidelberg, Germany