Overview

This trial is active, not recruiting.

Conditions albuminuria, diabetes mellitus, type 2, diabetes complications
Treatment mindfulness based stress reduction
Sponsor Heidelberg University
Start date January 2005
End date March 2012
Trial size 110 participants
Trial identifier NCT00263419, HD-Med1-01/05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Progression of albuminuria
time frame: 1,2,3,4 and 5 year

Secondary Outcomes

Measure
Mortality
time frame: 3,4 and 5 years
Late diabetic complications (micro-macrovascular)
time frame: 1,2,3,4 and 5 years
Cardiovascular Events
time frame: 1, 2,3,4 and 5 years
Nuclear Factor kappa B as marker of psychosocial stress
time frame: 1,2,3,4 and 5 years
Quality of life
time frame: post intervention, 1,2,3,4 and 5 years
Psychological symptoms
time frame: post intervention, 1,2,3,4 and 5 years
Cardiovascular risk factors
time frame: post intervention, 1,2,3,4 and 4 years

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

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

Additional Information

Official title Psychosoziale Intervention Zur Reduktion Diabetischer Spätschäden Bei Diabetes Mellitus Typ 2
Principal investigator Peter P Nawroth, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by Heidelberg University.