Effects of Stress Reduction on Cardiovascular Risk Factors in Type 2 Diabetes Patients with Early Kidney Disease – Results of a Randomized Controlled Trial (HEIDIS)

Abstract

Objective:

Current guidelines for the treatment of type 2 diabetes focus on pharmacological treatment of glucose and cardio-vascular risk factors. The aim of this prospective randomized controlled intervention study was to examine the effects of a psychosocial intervention on clinical endpoints and risk factors in patients with type 2 diabetes and early diabetic kidney disease.

Methods:

110 patients were randomized to receive an 8-week mindfulness-based stress reduction (MBSR) training (n=53) compared to standard care (n=57). The study was carried out open-labelled and randomization was performed computer-generated in a 1:1 ratio. Primary outcome of the study was the change in urinary albumin excretion (albumin-creatinine-ratio, ACR); secondary outcomes were metabolic parameters, intima media thickness (IMT), psychosocial parameters and cardiovascular events.

Results:

89 patients (42 in control group and 47 in intervention group) were analysed after 3 years of follow-up. After 1 year, the intervention group showed a reduction of ACR from 44 [16/80] to 39 [20/71] mg/g, while controls increased from 47 [16/120] to 59 [19/128] mg/g (p=0.05). Parallel to the reduction of stress levels after 1 year, the intervention-group additionally showed reduced catecholamine levels (p<0.05), improved 24 h-mean arterial (p<0.05) and maximum systolic blood pressure (p<0.01), as well as a reduction in IMT (p<0.01). However, these effects were lost after 2 and 3 years of follow-up.

Conclusions:

This is the first study to show that a psychosocial intervention improves cardiovascular risk factors in high risk type 2 diabetes patients.

Trial-Registration: NCT00263419

http://clinicaltrials.gov/ct2/show/NCT00263419

Trial registration: clinicaltrials.gov-Identifier: NCT00263419

Key words

type 2 diabetes - psychosocial stress - MBSR - diabetic kidney disease - cardiovascular risk

^* PMH and PPN contributed equally to this study

^† Angelika Bierhaus died on April 15^th, 2012.

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