title: 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: 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.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.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.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.
authors.affiliation: Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Kopf
authors.affiliation: Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany.
authors.forename: D
authors.initials: D
authors.lastname: Oikonomou
authors.affiliation: Department of Medicine II and Psychosomatics, University of Heidelberg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Hartmann
authors.affiliation: Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Feier
authors.affiliation: Department of Medicine II and Psychosomatics, University of Heidelberg, Germany.
authors.forename: V
authors.initials: V
authors.lastname: Faude-Lang
authors.affiliation: Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Morcos
authors.affiliation: Department of Medicine IV and Clinical Chemistry, University of Tübingen, Germany.
authors.forename: H-U
authors.initials: HU
authors.lastname: Häring
authors.affiliation: Department of Medicine II and Psychosomatics, University of Heidelberg, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Herzog
authors.affiliation: Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Bierhaus
authors.affiliation: Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany.
authors.forename: P M
authors.initials: PM
authors.lastname: Humpert
authors.affiliation: Department of Medicine I and Clinical Chemistry; University of Heidelberg, Germany.
authors.forename: P P
authors.initials: PP
authors.lastname: Nawroth
mesh_terms: D002318:Cardiovascular Diseases / Q000517:prevention & control / Q000523:psychology; D003924:Diabetes Mellitus, Type 2 / Q000523:psychology / Q000628:therapy; D003928:Diabetic Nephropathies / Q000523:psychology / Q000628:therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D013315:Stress, Psychological / Q000523:psychology / Q000628:therapy