Remission of type 2 diabetes and improved diastolic function by combining structured exercise with meal replacement and food reintroduction among young adults: the RESET for REMISSION randomised controlled trial protocol.
Remission of type 2 diabetes and improved diastolic function by combining structured exercise with meal replacement and food reintroduction among young adults: the RESET for REMISSION randomised controlled trial protocol.
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DOI：
10.1136/bmjopen-2022-063888
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发表时间：
2022-09-21
期刊：
影响因子：
2.9
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中科院分区：
文献类型：
--
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2型糖尿病（T2 DM）在40岁之前发病，心血管疾病的终生风险增加。舒张功能障碍是其最早的心脏表现。低能量饮食结合膳食替代产品可以诱导糖尿病缓解，但不会导致舒张功能改善，不像监督运动干预。我们正在研究低能量饮食和监督运动干预相结合对T2 DM缓解的影响，舒张早期峰值应变率是一种敏感的基于MRI的指标，作为关键的次要结局。这项前瞻性、随机、两组、开放标签、设盲终点疗效试验正在蒙特利尔、埃德蒙顿和莱斯特进行。我们正在招募100名年龄在18-45岁之间、诊断为T2 DM 6年内、未接受胰岛素治疗且患有肥胖症的患者。在强化阶段（12周），积极干预参与者采用800-900千卡/天的低能量饮食，将代餐产品与一些食物结合起来，并接受监督运动训练（有氧和阻力），每周三次。维持阶段（12周）的重点是维持强化阶段期间实现的任何体重减轻和运动实践;产品和运动监督逐渐减少，但在适用时重新开始，体重反弹和/或运动减少。控制臂接受标准护理。主要结局为T2 DM缓解（第24周时血红蛋白A1 c低于6.5%，维持治疗期间未使用降糖药物）。缓解分析将采用分层Fisher精确检验统计量按意向治疗进行。该试验已在莱斯特（东米德兰兹-诺丁汉研究伦理委员会（21/EM/0026））、蒙特利尔（麦吉尔大学健康中心研究伦理委员会（缓解期/2021-7148））和埃德蒙顿（阿尔伯塔大学健康研究伦理委员会（Pro 00101088））获得批准。研究结果将被广泛分享（出版物、演讲、新闻稿、社交媒体平台），并将为有效性试验提供信息。ISRCTN15487120。
Type 2 diabetes mellitus (T2DM) onset before 40 years of age has a magnified lifetime risk of cardiovascular disease. Diastolic dysfunction is its earliest cardiac manifestation. Low energy diets incorporating meal replacement products can induce diabetes remission, but do not lead to improved diastolic function, unlike supervised exercise interventions. We are examining the impact of a combined low energy diet and supervised exercise intervention on T2DM remission, with peak early diastolic strain rate, a sensitive MRI-based measure, as a key secondary outcome. This prospective, randomised, two-arm, open-label, blinded-endpoint efficacy trial is being conducted in Montreal, Edmonton and Leicester. We are enrolling 100 persons 18–45 years of age within 6 years’ T2DM diagnosis, not on insulin therapy, and with obesity. During the intensive phase (12 weeks), active intervention participants adopt an 800–900 kcal/day low energy diet combining meal replacement products with some food, and receive supervised exercise training (aerobic and resistance), three times weekly. The maintenance phase (12 weeks) focuses on sustaining any weight loss and exercise practices achieved during the intensive phase; products and exercise supervision are tapered but reinstituted, as applicable, with weight regain and/or exercise reduction. The control arm receives standard care. The primary outcome is T2DM remission, (haemoglobin A1c of less than 6.5% at 24 weeks, without use of glucose-lowering medications during maintenance). Analysis of remission will be by intention to treat with stratified Fisher’s exact test statistics. The trial is approved in Leicester (East Midlands – Nottingham Research Ethics Committee (21/EM/0026)), Montreal (McGill University Health Centre Research Ethics Board (RESET for remission/2021-7148)) and Edmonton (University of Alberta Health Research Ethics Board (Pro00101088). Findings will be shared widely (publications, presentations, press releases, social media platforms) and will inform an effectiveness trial. ISRCTN15487120.
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