Saito Toshikazu, Watanabe Makoto, Nishida Junko, Izumi Tomono, Omura Masao, Takagi Toshikazu, Fukunaga Ryuzo, Bandai Yasutsugu, Tajima Naoko, Nakamura Yosikazu, Ito Masaharu
Department of Internal Medicine, Social Insurance Chuo General Hospital, Tokyo, Japan.
Arch Intern Med. 2011 Aug 8;171(15):1352-60. doi: 10.1001/archinternmed.2011.275.
Previous studies demonstrated that intensive lifestyle modification can prevent type 2 diabetes mellitus among those with impaired glucose tolerance, but similar beneficial results have not been proved among those with impaired fasting glucose levels. We investigated the efficacy of lifestyle modification on type 2 diabetes incidence among those with impaired fasting glucose levels.
The present study was an unmasked, multicenter, randomized, controlled trial. A total of 641 overweight Japanese (aged 30-60 years) with impaired fasting glucose levels were recruited nationwide in Japan and randomly assigned to a frequent intervention group (n = 311) or a control group (n = 330). For 36 months after randomization, the frequent intervention group received individual instructions and follow-up support for lifestyle modification from the medical staff 9 times. The control group received similar individual instructions 4 times at 12-month intervals during the same period. The primary outcome was type 2 diabetes incidence in annual 75-g oral glucose tolerance tests, diagnosed according to World Health Organization criteria.
There were no significant differences between the allocation groups in baseline characteristics and dropout rates. Estimated cumulative incidences of type 2 diabetes were 12.2% in the frequent intervention group and 16.6% in the control group. Overall, the adjusted hazard ratio in the frequent intervention group was 0.56 (95% confidence interval, 0.36-0.87). In the post hoc subgroup analyses, the hazard ratio reduced to 0.41 (95% confidence interval, 0.24-0.69) among participants with impaired glucose tolerance at baseline, and to 0.24 (0.12-0.48) among those with baseline hemoglobin A(1c) levels of 5.6% or more (the Japan Diabetes Society method). Such risk reduction was not observed among those with isolated impaired fasting glucose findings or baseline hemoglobin A(1c) levels of less than 5.6%.
Lifestyle modifications can prevent type 2 diabetes among overweight Japanese with impaired fasting glucose levels. In addition, identifying individuals with more deteriorated glycemic status by using 75-g oral glucose tolerance test findings or, especially, measurement of hemoglobin A(1c) levels, could enhance the efficacy of lifestyle modifications.
umin.ac.jp/ctr Identifier: UMIN000001959.
既往研究表明，强化生活方式干预可预防糖耐量受损者发生2型糖尿病，但空腹血糖受损者尚未证实有类似的有益结果。我们调查了生活方式干预对空腹血糖受损者2型糖尿病发病率的影响。
本研究为非盲、多中心、随机对照试验。在日本全国招募了641名空腹血糖受损的超重日本人（年龄30 - 60岁），随机分为频繁干预组（n = 311）和对照组（n = 330）。随机分组后36个月，频繁干预组接受医务人员9次关于生活方式干预的个体化指导和随访支持。对照组在同一时期每隔12个月接受4次类似的个体化指导。主要结局是根据世界卫生组织标准，在每年的75g口服葡萄糖耐量试验中2型糖尿病的发病率。
两组在基线特征和失访率方面无显著差异。频繁干预组2型糖尿病的估计累积发病率为12.2%，对照组为16.6%。总体而言，频繁干预组的校正风险比为0.56（95%置信区间，0.36 - 0.87）。在事后亚组分析中，基线糖耐量受损的参与者中风险比降至0.41（95%置信区间，0.24 - 0.69），基线糖化血红蛋白A1c水平为5.6%或更高（日本糖尿病学会方法）的参与者中风险比降至0.24（0.12 - 0.48）。在单纯空腹血糖受损或基线糖化血红蛋白A1c水平低于5.6%的参与者中未观察到这种风险降低。
生活方式干预可预防空腹血糖受损的超重日本人发生2型糖尿病。此外，通过75g口服葡萄糖耐量试验结果，特别是通过测量糖化血红蛋白A1c水平来识别血糖状态更差的个体，可提高生活方式干预的效果。
umin.ac.jp/ctr标识符：UMIN000001959 。
