Effects of stress reduction on cardiovascular risk factors in type 2 diabetes patients with early kidney disease - results of a randomized controlled trial (HEIDIS).
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
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
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 |
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.