Balducci Stefano, Zanuso Silvano, Nicolucci Antonio, De Feo Pierpaolo, Cavallo Stefano, Cardelli Patrizia, Fallucca Sara, Alessi Elena, Fallucca Francesco, Pugliese Giuseppe
Diabetes Division, Sant'Andrea Hospital, Rome, Italy.
Arch Intern Med. 2010 Nov 8;170(20):1794-803. doi: 10.1001/archinternmed.2010.380.
This study aimed to assess the efficacy of an intensive exercise intervention strategy in promoting physical activity (PA) and improving hemoglobin A(1c)(HbA(1c)) level and other modifiable cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM).
Of 691 eligible sedentary patients with T2DM and the metabolic syndrome, 606 were enrolled in 22 outpatient diabetes clinics across Italy and randomized by center, age, and diabetes treatment to twice-a-week supervised aerobic and resistance training plus structured exercise counseling (exercise group) vs counseling alone (control group) for 12 months. End points included HbA(1c) level (primary) and other cardiovascular risk factors and coronary heart disease risk scores (secondary).
The mean (SD) volume of PA (metabolic equivalent hours per week) was significantly higher (P < .001) in the exercise (total PA [nonsupervised conditioning PA + supervised PA], 20.0 [0.9], and nonsupervised, 12.4 [7.4]) vs control (10.0 [8.7]) group. Compared with the control group, supervised exercise produced significant improvements (mean difference [95% confidence interval]) in physical fitness; HbA(1c) level (-0.30% [-0.49% to -0.10%]; P < .001); systolic (-4.2 mm Hg [-6.9 to -1.6 mm Hg]; P = .002) and diastolic (-1.7 mm Hg [-3.3 to -1.1 mm Hg]; P = .03) blood pressure; high-density lipoprotein (3.7 mg/dL [2.2 to 5.3 mg/dL]; P < .001) and low-density lipoprotein (-9.6 mg/dL [-15.9 to -3.3 mg/dL]; P = .003) cholesterol level; waist circumference (-3.6 cm [-4.4 to -2.9 cm]; P < .001); body mass index; insulin resistance; inflammation; and risk scores. These parameters improved only marginally in controls.
This exercise intervention strategy was effective in promoting PA and improving HbA(1c) and cardiovascular risk profile. Conversely, counseling alone, though successful in achieving the currently recommended amount of activity, was of limited efficacy on cardiovascular risk factors, suggesting the need for a larger volume of PA in these high-risk subjects. Trial Registration isrctn.org Identifier: ISRCTN04252749.
本研究旨在评估强化运动干预策略对促进2型糖尿病（T2DM）患者的身体活动（PA）、改善糖化血红蛋白A1c（HbA1c）水平及其他可改变的心血管危险因素的效果。
在691例符合条件的久坐不动的T2DM和代谢综合征患者中，606例患者被纳入意大利22家门诊糖尿病诊所，按中心、年龄和糖尿病治疗情况随机分组，接受每周两次的有氧和抗阻训练及结构化运动咨询（运动组）或仅接受咨询（对照组），为期12个月。终点指标包括HbA1c水平（主要指标）及其他心血管危险因素和冠心病风险评分（次要指标）。
运动组（总PA[非监督性适应性PA+监督性PA]，20.0[0.9]，非监督性，12.4[7.4]）的PA平均（标准差）量（每周代谢当量小时数）显著高于对照组（10.0[8.7]）（P<.001）。与对照组相比，监督性运动在体能、HbA1c水平（-0.30%[-0.49%至-0.10%]；P<.001）、收缩压（-4.2mmHg[-6.9至-1.6mmHg]；P=.002）和舒张压（-1.7mmHg[-3.3至-1.1mmHg]；P=.03）、高密度脂蛋白（3.7mg/dL[2.2至5.3mg/dL]；P<.001）和低密度脂蛋白（-9.6mg/dL[-15.9至-3.3mg/dL]；P=.003）胆固醇水平、腰围（-3.6cm[-4.4至-2.9cm]；P<.001）、体重指数、胰岛素抵抗、炎症和风险评分方面有显著改善。这些参数在对照组中仅略有改善。
该运动干预策略在促进PA及改善HbA1c和心血管风险状况方面有效。相反，仅咨询虽然成功达到了目前推荐的活动量，但对心血管危险因素的疗效有限，提示这些高危患者需要更多的PA。试验注册isrctn.org标识符：ISRCTN04252749。
