目的:评估由频繁饮食组成的短期强化代谢干预对2型糖尿病缓解的影响。运动和糖尿病管理教练,二甲双胍和固定比例胰岛素degludec/利拉鲁肽。
方法:在一项多中心开放标签随机对照试验中,糖尿病诊断后5年内未接受胰岛素治疗的参与者被分配到16周缓解干预方案或标准治疗,并在停用降糖药物后随访糖尿病复发和持续缓解一年。
结果:共有159名57±10岁的参与者,糖尿病病程2.6±1.5年,体重指数33.5±6.5kg/m2和糖化血红蛋白(HbA1c)水平53±7mmol/mol被随机和分析(79干预,80对照)。在16周的干预期结束时,与对照组相比,干预参与者实现了较低的HbA1c水平(40±4vs.51±7mmol/mol;p<0.0001),并且减轻了更多的体重(3.3±4.4%vs.1.9±3.0%;p=0.02)。与对照组相比,干预组的糖尿病复发总体风险较低(风险比0.63,95%置信区间[CI]0.45,0.88;p=0.007),尽管这并没有随着时间的推移而持续。12周时,干预组的缓解率没有明显高于对照组(17.7%vs.12.5%,相对风险[RR]1.42,95%CI0.67,3.00;p=0.36)或52周时(6.3%与3.8%,RR1.69,95%CI0.42,6.82)。
结论:强化缓解诱导干预包括固定比例的degludec胰岛素/利拉鲁肽可降低2型糖尿病在1年内复发而不持续缓解的风险。
OBJECTIVE: To evaluate the effect on type 2 diabetes remission of short-term intensive metabolic intervention consisting of frequent dietary, exercise and diabetes management coaching, metformin and fixed-ratio insulin degludec/liraglutide.
METHODS: In a multicentre open-label randomized controlled trial, insulin-naïve participants within 5 years of diabetes diagnosis were assigned to a 16-week remission intervention regimen or standard care, and followed for relapse of diabetes and sustained remission for an additional year after stopping glucose-lowering drugs.
RESULTS: A total of 159 participants aged 57 ± 10 years, with diabetes duration 2.6 ± 1.5 years, body mass index 33.5 ± 6.5 kg/m2, and glycated haemoglobin (HbA1c) level 53 ± 7 mmol/mol were randomized and analysed (79 intervention, 80 control). At the end of the 16-week intervention period, compared to controls, intervention participants achieved lower HbA1c levels (40 ± 4 vs. 51 ± 7 mmol/mol; p < 0.0001), and lost more weight (3.3 ± 4.4% vs. 1.9 ± 3.0%; p = 0.02). There was a lower hazard of diabetes relapse overall in the intervention group compared to controls (hazard ratio 0.63, 95% confidence interval [CI] 0.45, 0.88; p = 0.007), although this was not sustained over time. Remission rates in the intervention group were not significantly higher than in the control group at 12 weeks (17.7% vs. 12.5%, relative risk [RR] 1.42, 95% CI 0.67, 3.00; p = 0.36) or at 52 weeks (6.3% vs. 3.8%, RR 1.69, 95% CI 0.42, 6.82) following the intervention period.
CONCLUSIONS: An intensive remission-induction intervention including fixed-ratio insulin degludec/liraglutide reduced the risk of type 2 diabetes relapse within 1 year without sustained remission.