日本一项针对 2 型糖尿病成年人的有氧和抗阻运动相结合的结构化项目的随机对照试验。
A randomized controlled trial of a structured program combining aerobic and resistance exercise for adults with type 2 diabetes in Japan.
作者信息
Terauchi Yasuo, Takada Tetsushi, Yoshida Satoshi
机构信息
Department of Endocrinology and Metabolism, Yokohama City University, Yokohama, Japan.
Clinical Operation and Innovation Group-Japan/Asia Clinical Development Department 2, Astellas Pharma Inc, 2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo, 103-8411 Japan.
出版信息
Diabetol Int. 2021 Apr 28;13(1):75-84. doi: 10.1007/s13340-021-00506-5. eCollection 2022 Jan.
BACKGROUND
We assessed the effect of supervised, combined aerobic and resistance exercise on diabetic parameters in Japanese patients with type 2 diabetes mellitus (T2DM).
METHODS
This 12-week, multicenter (17 medical institutions), open-label, parallel-group study (clinicaltrials.jp; JapicCTI-184002), randomized (1:1) Japanese patients aged 20-75 years with T2DM and hemoglobin A1c (HbA1c) of 7.0-10.0% to supervised exercise ( = 113) or standard therapy ( = 115). The supervised exercise group undertook supervised aerobic (30 min) and resistance exercise 3 times/week (20 designated gyms). Primary endpoint was change in HbA1c from baseline at week 13. Secondary endpoints were change in fasting blood glucose (FBG), glycoalbumin, fasting insulin, homeostatic model assessment of insulin resistance (HOMA-IR), and HOMA-β at week 13.
RESULTS
Of 228 randomized patients, 97 (85.8%) in the supervised exercise group and 108 (93.9%) in the standard therapy group completed the study. Supervised exercise significantly lowered HbA1c at week 13 versus standard therapy (estimated difference in change from baseline [95% confidence interval]: - 0.44% [- 0.61, - 0.28], < 0.001). Supervised exercise also significantly decreased FBG (estimated difference: - 13.0 [- 19.2, - 6.7] mg/dL) and glycoalbumin (estimated difference: - 1.52% [- 2.10, - 0.93]) compared with standard therapy. Fasting insulin (- 0.5 µIU/mL) and HOMA-IR (- 0.3) decreased with supervised exercise, but group differences were not significant. Treatment-emergent adverse events were more frequent in the supervised exercise group (42.5%) than in the standard therapy group (29.6%); however, no major safety concerns were identified.
CONCLUSIONS
A structured, supervised, aerobic and resistance exercise program improved HbA1c and was well accepted among patients with T2DM.
SUPPLEMENTARY INFORMATION
The online version contains supplementary material available at 10.1007/s13340-021-00506-5.
背景
我们评估了在日本2型糖尿病（T2DM）患者中，有监督的有氧运动和抗阻运动相结合对糖尿病参数的影响。
方法
这项为期12周的多中心（17家医疗机构）、开放标签、平行组研究（clinicaltrials.jp；JapicCTI-184002），将年龄在20 - 75岁、糖化血红蛋白（HbA1c）为7.0 - 10.0%的日本T2DM患者随机（1:1）分为有监督运动组（n = 113）和标准治疗组（n = 115）。有监督运动组每周在指定的20家健身房进行3次有监督的有氧运动（30分钟）和抗阻运动。主要终点是第13周时HbA1c相对于基线的变化。次要终点是第13周时空腹血糖（FBG）、糖化白蛋白、空腹胰岛素、胰岛素抵抗稳态模型评估（HOMA-IR）和HOMA-β的变化。
结果
在228例随机分组的患者中，有监督运动组97例（85.8%）和标准治疗组108例（93.9%）完成了研究。与标准治疗相比，有监督运动在第13周时显著降低了HbA1c（从基线变化的估计差异[95%置信区间]：-0.44%[-0.61，-0.28]，P < 0.001）。与标准治疗相比时，有监督运动还显著降低了FBG（估计差异：-13.0[-19.2，-6.7]mg/dL）和糖化白蛋白（估计差异：-1.52%[-2.10，-0.93]）。有监督运动使空腹胰岛素（-0.
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