Termannsen Anne-Ditte, Varming Annemarie, Bjerre Natasja, Wodschow Helena Z, Hansen Gitte S, Jensen Nicole J, Persson Frederik, Bagger Jonatan I, Panda Satchidananda, Finlayson Graham, Ewers Bettina, Hansen Dorte L, Nørgaard Kirsten, Rungby Jørgen, Grunnet Louise G, Blond Martin B, Hempler Nana F, Færch Kristine, Quist Jonas S
Copenhagen University Hospital-Steno Diabetes Center Copenhagen, Herlev, Denmark.
Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Diabet Med. 2025 May;42(5):e15506. doi: 10.1111/dme.15506. Epub 2025 Jan 11.
Time-restricted eating (TRE) limits the time for food intake to typically 6-10 h/day without other dietary restrictions. The aim of the RESET2 (the REStricted Eating Time in the treatment of type 2 diabetes) trial is to investigate the effects on glycaemic control (HbA) and the feasibility of a 1-year TRE intervention in individuals with overweight/obesity and type 2 diabetes. The aim of the present paper is to describe the protocol for the RESET2 trial.
RESET2 is a randomised, controlled, parallel-group, open-label trial. One hundred and sixty individuals with type 2 diabetes (HbA >53 mmol/mol (>7.0%)), and Body Mass Index ≥25 kg/m will be randomised to standard care plus TRE, or to standard care and habitual living. Both the intervention and control group will follow standard diabetes care including regular clinical visits 3-4 times/year. The intervention is divided into two periods: (1) a 3-month TRE period with a fixed eating window with a self-selected timing to obtain data from the participants' experiences with TRE and (2) a 9-month individually adjusted TRE period. Participants in the TRE group will be instructed to reduce their eating window by a minimum of 3 h/day compared to the habitual eating window and with an eating window of 8-10 h/day. Test days will be scheduled at baseline, after 3 months and after 1 year. The primary outcome is HbA (evaluated 3 months and 1 year after randomisation) and secondary outcomes are body weight, fat mass, continuous glucose monitoring derived time-in-range and use of antidiabetic medicine (evaluated 1 year after randomisation). Additionally, we will conduct a process evaluation to assess whether the TRE intervention functioned as hypothesised.
限时进食（TRE）将食物摄入时间限制在通常每天6 - 10小时，且无其他饮食限制。RESET2（2型糖尿病治疗中的限时进食时间）试验的目的是研究对血糖控制（糖化血红蛋白）的影响以及对超重/肥胖的2型糖尿病患者进行为期1年的限时进食干预的可行性。本文的目的是描述RESET2试验的方案。
RESET2是一项随机、对照、平行组、开放标签试验。160名2型糖尿病患者（糖化血红蛋白>53 mmol/mol（>7.0%））且体重指数≥25 kg/m² 将被随机分为标准护理加限时进食组，或标准护理和习惯性生活组。干预组和对照组都将遵循标准糖尿病护理，包括每年进行3 - 4次定期临床就诊。干预分为两个阶段：（1）为期3个月的限时进食阶段，有一个固定的进食窗口，进食时间由参与者自行选择，以获取参与者限时进食体验的数据；（2）为期9个月的个体调整限时进食阶段。限时进食组的参与者将被指导与习惯进食窗口相比，每天至少减少3小时的进食窗口，进食窗口为8 - 10小时/天。测试日安排在基线、3个月后和1年后。主要结局是糖化血红蛋白（随机分组后3个月和1年进行评估），次要结局是体重、脂肪量、持续葡萄糖监测得出的血糖达标时间以及抗糖尿病药物的使用（随机分组后1年进行评估）。此外，我们将进行过程评估，以评估限时进食干预是否如假设那样发挥作用。
