Reynolda Campus, Wake Forest University, Winston-Salem, NC 27109, USA.
N Engl J Med. 2012 Mar 29;366(13):1209-17. doi: 10.1056/NEJMoa1110294.
Adults with type 2 diabetes mellitus often have limitations in mobility that increase with age. An intensive lifestyle intervention that produces weight loss and improves fitness could slow the loss of mobility in such patients.
We randomly assigned 5145 overweight or obese adults between the ages of 45 and 74 years with type 2 diabetes to either an intensive lifestyle intervention or a diabetes support-and-education program; 5016 participants contributed data. We used hidden Markov models to characterize disability states and mixed-effects ordinal logistic regression to estimate the probability of functional decline. The primary outcome was self-reported limitation in mobility, with annual assessments for 4 years.
At year 4, among 2514 adults in the lifestyle-intervention group, 517 (20.6%) had severe disability and 969 (38.5%) had good mobility; the numbers among 2502 participants in the support group were 656 (26.2%) and 798 (31.9%), respectively. The lifestyle-intervention group had a relative reduction of 48% in the risk of loss of mobility, as compared with the support group (odds ratio, 0.52; 95% confidence interval, 0.44 to 0.63; P<0.001). Both weight loss and improved fitness (as assessed on treadmill testing) were significant mediators of this effect (P<0.001 for both variables). Adverse events that were related to the lifestyle intervention included a slightly higher frequency of musculoskeletal symptoms at year 1.
Weight loss and improved fitness slowed the decline in mobility in overweight adults with type 2 diabetes. (Funded by the Department of Health and Human Services and others; ClinicalTrials.gov number, NCT00017953.).
2 型糖尿病患者常伴有行动能力受限,且该限制会随年龄增长而增加。强化生活方式干预可减轻体重、提高身体机能,从而减缓此类患者的行动能力下降。
我们将 5145 名年龄在 45 至 74 岁之间患有 2 型糖尿病且超重或肥胖的成年人随机分为强化生活方式干预组或糖尿病支持与教育组;共有 5016 名参与者提供了数据。我们使用隐马尔可夫模型来描述残疾状态,并使用混合效应有序逻辑回归来估计功能下降的概率。主要结局是移动受限的自我报告,随访 4 年。
在生活方式干预组的 2514 名成年人中,有 517 名(20.6%)在第 4 年出现严重残疾,969 名(38.5%)具有良好的移动能力;支持组的 2502 名参与者中,分别有 656 名(26.2%)和 798 名(31.9%)出现严重残疾和具有良好的移动能力。与支持组相比,生活方式干预组的移动能力丧失风险降低了 48%(比值比,0.52;95%置信区间,0.44 至 0.63;P<0.001)。体重减轻和身体机能改善(通过跑步机测试评估)均是该效果的重要中介因素(P<0.001)。与生活方式干预相关的不良事件包括第 1 年肌肉骨骼症状的发生频率略有增加。
在超重的 2 型糖尿病成年人中,体重减轻和身体机能改善减缓了移动能力的下降。(由美国卫生与公众服务部等资助;ClinicalTrials.gov 注册号:NCT00017953。)