Exp Clin Endocrinol Diabetes 2014; 122(06): 341-349
DOI: 10.1055/s-0034-1372583
Article
© J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart · New York

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

S. Kopf
1   Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany
,
D. Oikonomou
1   Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany
,
M. Hartmann
2   Department of Medicine II and Psychosomatics, University of Heidelberg, Germany
,
F. Feier
1   Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany
,
V. Faude-Lang
2   Department of Medicine II and Psychosomatics, University of Heidelberg, Germany
3   Department of Psychosomatic Medicine and Psychotherapy, University of Hamburg-Eppendorf, Hamburg, Germany
,
M. Morcos
1   Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany
4   Stoffwechselzentrum Rhein-Pfalz, Mannheim – Speyer, Germany
,
H.-U. Häring
5   Department of Medicine IV and Clinical Chemistry, University of Tübingen, Germany
,
W. Herzog
2   Department of Medicine II and Psychosomatics, University of Heidelberg, Germany
,
A. Bierhaus
1   Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany
,
P. M. Humpert*
1   Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany
4   Stoffwechselzentrum Rhein-Pfalz, Mannheim – Speyer, Germany
,
P. P. Nawroth*
1   Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany
› Author Affiliations
Further Information

Publication History

received 17 September 2013
first decision 17 January 2014

accepted 18 March 2014

Publication Date:
05 May 2014 (online)

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

* PMH and PPN contributed equally to this study


Angelika Bierhaus died on April 15th, 2012.


 
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