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

Heidelberg University

Status: Unknown

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

Treatments: Behavioral: Mindfulness Based Stress Reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT00263419

HD-Med1-01/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)