Effects of Stress Reduction on Cardiovascular Risk Factors in Type 2 Diabetes Patients with Early Kidney Disease - Results of a Randomized Controlled Trial (HEIDIS)
Effects of Stress Reduction on Cardiovascular Risk Factors in Type 2 Diabetes Patients with Early Kidney Disease - Results of a Randomized Controlled Trial (HEIDIS)
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DOI：
10.1055/s-0034-1372583
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发表时间：
2014-06-01
影响因子：
1.8
通讯作者：
Nawroth, P. P.
中科院分区：
文献类型：
--
作者：
Kopf, S.;Oikonomou, D.;Nawroth, P. P.
目的：目前2型糖尿病的治疗指南侧重于对血糖和心血管危险因素的药物治疗。这项前瞻性随机对照干预研究的目的是检验心理社会干预对2型糖尿病合并早期糖尿病肾病患者临床终点和危险因素的影响。方法：110名患者随机接受为期8周的正念减压(MBSR)训练(n=53)和标准护理(n=57)。这项研究是开放标记的，随机分组是由计算机生成的，比例为1：1。研究的主要结果是尿白蛋白排泄量(白蛋白/肌酐比，ACR)的变化；次要结果是代谢参数、内膜中层厚度(IMT)、心理社会参数和心血管事件。结果：随访3年后，89例患者(对照组42例，干预组47例)进入分析阶段。1年后，干预组ACR从44[16/80]降至39[20/71]mg/g，而对照组从47[16/120]升至59[19/128]mg/g(p=0.05)。在1年后压力水平降低的同时，干预组还表现出儿茶酚胺水平的降低(p<；0.05)，24小时平均动脉(p<；0.05)和最大收缩压(p<；0.01)的改善，以及IMT的减少(p<；0.01)。然而，这些作用在2年和3年的随访中消失了。结论：这是第一项研究表明心理社会干预改善了高危2型糖尿病患者的心血管危险因素。
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.