Department of Endocrinology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
Department of Endocrinology, The Third Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, China.
JAMA Netw Open. 2024 Jun 3;7(6):e2416786. doi: 10.1001/jamanetworkopen.2024.16786.
An intermittent fasting plan consisting of 2 nonconsecutive fasting days and 5 days of habitual intake per week and meal replacement diet (5:2 MR) could provide additional benefits to patients with type 2 diabetes.
To evaluate the effect of the 5:2 MR on glycemic control among patients with early type 2 diabetes compared with metformin and empagliflozin.
DESIGN, SETTING, AND PARTICIPANTS: The EARLY (Exploration of Treatment of Newly Diagnosed Overweight/Obese Type 2 Diabetes Mellitus) study is a randomized, open-label, active parallel-controlled clinical trial conducted between November 13, 2020, and December 29, 2022, in 9 centers across China. A total of 509 eligible patients underwent screening, out of which 405 were randomly assigned to 3 groups and included in the intention-to-treat analysis.
Patients were randomly allocated in a 1:1:1 ratio to receive either metformin, empagliflozin, or 5:2 MR. The treatment was 16 weeks, with an 8-week follow-up.
The primary end point was the change in hemoglobin A1c (HbA1c) level from baseline to 16 weeks. Secondary end points included changes in body weight, anthropometric measurements, and biochemical parameters.
Of the 405 randomized participants (265 men [65.4%]; mean [SD] age, 45.5 [11.0] years; mean [SD] body mass index, 29.5 [4.1]; and mean [SD] HbA1c level, 7.9% [0.6%]), 332 completed the 16-week treatment. From baseline to week 16, participants in the 5:2 MR group showed the greatest reduction in HbA1c (least-squares mean [LSM], -1.9% [SE, 0.2%]), significantly greater than patients receiving metformin (LSM, -1.6% [SE, 0.2%]; adjusted LSM difference, -0.3% [95% CI, -0.4% to -0.1%]) and empagliflozin (LSM, -1.5% [SE, 0.2%]; adjusted LSM difference, -0.4% [95% CI, -0.6% to -0.2%]). At week 16, the mean weight loss in the 5:2 MR group (LSM, -9.7 kg [SE, 2.2 kg]) was greater than that in the metformin group (LSM, -5.5 kg [SE, 2.3 kg]) and empagliflozin group (LSM, -5.8 kg [SE, 2.3 kg]).
This randomized clinical trial of Chinese adults with overweight or obesity and with early type 2 diabetes found that 5:2 MR could improve glycemic outcomes and weight loss in the short term compared with metformin or empagliflozin, making it a promising initial intervention and early management for type 2 diabetes.
Chinese Clinical Trial Registry Identifier: ChiCTR2000040656.
由不连续的 2 天禁食和每周 5 天的习惯摄入以及代餐饮食组成的间歇性禁食计划（5:2MR）可能为 2 型糖尿病患者提供额外的益处。
评估 5:2MR 对与二甲双胍和恩格列净相比早期 2 型糖尿病患者血糖控制的影响。
设计、地点和参与者：EARLY（新诊断超重/肥胖 2 型糖尿病治疗的探索）研究是一项在中国 9 个中心进行的随机、开放标签、活性平行对照临床试验，于 2020 年 11 月 13 日至 2022 年 12 月 29 日进行。共有 509 名符合条件的患者接受了筛选，其中 405 名患者被随机分配到 3 组，并纳入意向治疗分析。
患者被随机分配以 1:1:1 的比例接受二甲双胍、恩格列净或 5:2MR。治疗时间为 16 周，随访 8 周。
主要终点是从基线到 16 周时血红蛋白 A1c（HbA1c）水平的变化。次要终点包括体重、人体测量学测量和生化参数的变化。
在 405 名随机参与者（265 名男性[65.4%]；平均[SD]年龄 45.5[11.0]岁；平均[SD]体重指数 29.5[4.1]；平均[SD]HbA1c 水平 7.9%[0.6%]）中，332 名完成了 16 周的治疗。从基线到第 16 周，5:2MR 组的参与者 HbA1c 下降最大（最小二乘均值[LSM]，-1.9%[SE，0.2%]），显著大于接受二甲双胍的患者（LSM，-1.6%[SE，0.2%]；调整后的 LSM 差异，-0.3%[95%CI，-0.4%至-0.1%]）和恩格列净（LSM，-1.5%[SE，0.2%]；调整后的 LSM 差异，-0.4%[95%CI，-0.6%至-0.2%]）。在第 16 周时，5:2MR 组的平均体重减轻（LSM，-9.7kg[SE，2.2kg]）大于二甲双胍组（LSM，-5.5kg[SE，2.3kg]）和恩格列净组（LSM，-5.8kg[SE，2.3kg]）。
这项针对中国超重或肥胖且患有早期 2 型糖尿病的成年人的随机临床试验发现，与二甲双胍或恩格列净相比，5:2MR 可以在短期内改善血糖控制和体重减轻，这使其成为 2 型糖尿病的一种有前途的初始干预和早期管理方法。
中国临床试验注册中心标识符：ChiCTR2000040656。
