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Effects of stress reduction on cardiovascular risk factors in type 2 diabetes patients with early kidney disease - results of a randomized controlled trial (HEIDIS).

Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association
June 1, 2014
S Kopf et al. (11 authors)
Journal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to examine the effects of an 8-week mindfulness-based stress reduction (MBSR) training on clinical endpoints and cardiovascular risk factors in patients with type 2 diabetes and early diabetic kidney disease.

Results Summary

After 1 year, the MBSR group showed reduced urinary albumin excretion, stress levels, catecholamine levels, improved blood pressure, and reduced intima media thickness, but these effects were not sustained after 2-3 years.

Population

Patients with type 2 diabetes and early diabetic kidney disease (n=110, randomized to intervention or control).

Effective Dosage

8-week MBSR training (specific frequency not detailed).

Duration

8 weeks (with follow-up assessments at 1, 2, and 3 years).

Interactions

None mentioned

Extracted Claims (8)
InterventionDirectionEndpointPopulationDosageImpactClaim #
mindfulness-based stress reduction (MBSR) training
decrease
urinary albumin excretion (albumin-creatinine-ratio, ACR)
patients with type 2 diabetes and early diabetic kidney disease
from 44 [16/80] to 39 [20/71] mg/g
showed a reduction
#1
standard care
increase
urinary albumin excretion (albumin-creatinine-ratio, ACR)
patients with type 2 diabetes and early diabetic kidney disease
from 47 [16/120] to 59 [19/128] mg/g
increased
#2
mindfulness-based stress reduction (MBSR) training
decrease
catecholamine levels
patients with type 2 diabetes and early diabetic kidney disease
p < 0.05
showed reduced
#3
mindfulness-based stress reduction (MBSR) training
decrease
24 h-mean arterial blood pressure
patients with type 2 diabetes and early diabetic kidney disease
p < 0.05
improved
#4
mindfulness-based stress reduction (MBSR) training
decrease
maximum systolic blood pressure
patients with type 2 diabetes and early diabetic kidney disease
p < 0.01
improved
#5
mindfulness-based stress reduction (MBSR) training
decrease
intima media thickness (IMT)
patients with type 2 diabetes and early diabetic kidney disease
p < 0.01
showed a reduction in
#6
mindfulness-based stress reduction (MBSR) training
no change
effects on cardiovascular risk factors
patients with type 2 diabetes and early diabetic kidney disease
after 2 and 3 years of follow-up
were lost
#7
psychosocial intervention
decrease
cardiovascular risk factors
high risk type 2 diabetes patients
-
improves
#8
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.

Medical Subject Headings (MeSH)
Cardiovascular DiseasesDiabetes Mellitus, Type 2Diabetic NephropathiesFemaleHumansMaleMiddle AgedProspective StudiesRisk FactorsStress, Psychological
Study Links
Quality Scores
SafetyNot Assessed
Efficacy70/10
Quality80/10
Citation Metrics
Total Citations35
Citations/Year3.2
Relative Citation Ratio1.63
NIH Percentile68%
Research Impact Scores
APT Score0.75
Weight Score1.70
Normalized Score0.64
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