McInnes Natalia, Smith Ada, Otto Rose, Vandermey Jeffrey, Punthakee Zubin, Sherifali Diana, Balasubramanian Kumar, Hall Stephanie, Gerstein Hertzel C
Department of Medicine, McMaster University, Hamilton, Ontario L8S 4K1, Canada.
Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario L8L 2X2, Canada.
J Clin Endocrinol Metab. 2017 May 1;102(5):1596-1605. doi: 10.1210/jc.2016-3373.
Medical strategies targeting remission of type 2 diabetes have not been systematically studied.
This trial assessed the feasibility, safety, and potential to induce remission of a short-term intensive metabolic strategy.
A randomized, parallel, open-label pilot trial with 83 participants followed for 52 weeks.
Ambulatory care.
Patients with type 2 diabetes of up to 3 years in duration.
Participants were randomized to: (1) an 8-week intensive metabolic intervention, (2) a 16-week intensive metabolic intervention, or (3) standard diabetes care. During the intensive intervention period, weight loss and normoglycemia were targeted using lifestyle approaches and treatment with metformin, acarbose, and insulin glargine. Diabetes drugs were then discontinued in the intervention groups and participants were followed for hyperglycemic relapse.
On-treatment normoglycemia.
At 8 weeks, 50.0% of the 8-week intervention group vs 3.6% of controls achieved normoglycemia on therapy [relative risk (RR), 14.0; 95% confidence interval (CI), 1.97 to 99.38), and at 16 weeks, these percentages were 70.4% in the 16-week group and 3.6% in controls (RR, 19.7; 95% CI, 2.83 to 137.13). Twelve weeks after completion of the intervention, 21.4% of the 8-week group compared with 10.7% of controls (RR, 2.00; 95% CI, 0.55 to 7.22) and 40.7% of the 16-week group compared with 14.3% of controls (RR, 2.85; 95% CI, 1.03 to 7.87) met hemoglobin A1C criteria for complete or partial diabetes remission.
A short course of intensive lifestyle and drug therapy achieves on-treatment normoglycemia and promotes sustained weight loss. It may also achieve prolonged, drug-free diabetes remission and strongly supports ongoing studies of novel medical regimens targeting remission.
针对2型糖尿病缓解的医学策略尚未得到系统研究。
本试验评估了一种短期强化代谢策略的可行性、安全性及诱导缓解的潜力。
一项随机、平行、开放标签的试点试验，83名参与者随访52周。
门诊护理。
病程长达3年的2型糖尿病患者。
参与者被随机分为：（1）为期8周的强化代谢干预组，（2）为期16周的强化代谢干预组，或（3）标准糖尿病护理组。在强化干预期，通过生活方式干预以及使用二甲双胍、阿卡波糖和甘精胰岛素治疗来实现体重减轻和血糖正常。然后干预组停用糖尿病药物，对参与者进行高血糖复发随访。
治疗期间血糖正常。
在8周时，8周干预组50.0%的参与者与3.6%的对照组参与者在治疗时实现血糖正常[相对危险度（RR），14.0；95%置信区间（CI），1.97至99.38]，在16周时，16周组的这一百分比为70.4%，对照组为3.6%（RR，19.7；95%CI，2.83至137.13）。干预完成12周后，8周组21.4%的参与者与对照组10.7%的参与者（RR，2.00；95%CI，0.55至7.22）以及16周组40.7%的参与者与对照组14.3%的参与者（RR，2.85；95%CI，1.03至7.87）达到血红蛋白A1C完全或部分糖尿病缓解标准。
短期强化生活方式和药物治疗可实现治疗期间血糖正常并促进持续体重减轻。它还可能实现长期无药糖尿病缓解，并有力支持针对缓解的新型医学方案的正在进行的研究。
