Anne-Ditte Termannsen, Annemarie Varming, Natasja Bjerre, Helena Z Wodschow, Gitte S Hansen, Nicole J Jensen, Frederik Persson, Jonatan I Bagger, Satchidananda Panda, Graham Finlayson, Bettina Ewers, Dorte L Hansen, Kirsten Nørgaard, Jørgen Rungby, Louise G Grunnet, Martin B Blond, Nana F Hempler, Kristine Færch, Jonas S Quist
{"title":"一项为期1年的随机、对照、平行组、开放标签试验的方案，研究2型糖尿病患者限时饮食的效果和可行性——2型糖尿病治疗中的限时饮食（RESET2）试验。","authors":"Anne-Ditte Termannsen, Annemarie Varming, Natasja Bjerre, Helena Z Wodschow, Gitte S Hansen, Nicole J Jensen, Frederik Persson, Jonatan I Bagger, Satchidananda Panda, Graham Finlayson, Bettina Ewers, Dorte L Hansen, Kirsten Nørgaard, Jørgen Rungby, Louise G Grunnet, Martin B Blond, Nana F Hempler, Kristine Færch, Jonas S Quist","doi":"10.1111/dme.15506","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>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<sub>1c</sub>) 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.</p><p><strong>Methods: </strong>RESET2 is a randomised, controlled, parallel-group, open-label trial. One hundred and sixty individuals with type 2 diabetes (HbA<sub>1c</sub> >53 mmol/mol (>7.0%)), and Body Mass Index ≥25 kg/m<sup>2</sup> 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<sub>1c</sub> (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.</p>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":" ","pages":"e15506"},"PeriodicalIF":3.2000,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Protocol for a 1-year randomised, controlled, parallel group, open-label trial on the effects and feasibility of time-restricted eating in individuals with type 2 diabetes- The Restricted Eating Time in the Treatment of Type 2 Diabetes (RESET2) trial.\",\"authors\":\"Anne-Ditte Termannsen, Annemarie Varming, Natasja Bjerre, Helena Z Wodschow, Gitte S Hansen, Nicole J Jensen, Frederik Persson, Jonatan I Bagger, Satchidananda Panda, Graham Finlayson, Bettina Ewers, Dorte L Hansen, Kirsten Nørgaard, Jørgen Rungby, Louise G Grunnet, Martin B Blond, Nana F Hempler, Kristine Færch, Jonas S Quist\",\"doi\":\"10.1111/dme.15506\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aim: </strong>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<sub>1c</sub>) 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.</p><p><strong>Methods: </strong>RESET2 is a randomised, controlled, parallel-group, open-label trial. One hundred and sixty individuals with type 2 diabetes (HbA<sub>1c</sub> >53 mmol/mol (>7.0%)), and Body Mass Index ≥25 kg/m<sup>2</sup> 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<sub>1c</sub> (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). 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Protocol for a 1-year randomised, controlled, parallel group, open-label trial on the effects and feasibility of time-restricted eating in individuals with type 2 diabetes- The Restricted Eating Time in the Treatment of Type 2 Diabetes (RESET2) trial.
Aim: 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 (HbA1c) 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.
Methods: RESET2 is a randomised, controlled, parallel-group, open-label trial. One hundred and sixty individuals with type 2 diabetes (HbA1c >53 mmol/mol (>7.0%)), and Body Mass Index ≥25 kg/m2 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 HbA1c (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.
期刊介绍：
Diabetic Medicine, the official journal of Diabetes UK, is published monthly simultaneously, in print and online editions.
The journal publishes a range of key information on all clinical aspects of diabetes mellitus, ranging from human genetic studies through clinical physiology and trials to diabetes epidemiology. We do not publish original animal or cell culture studies unless they are part of a study of clinical diabetes involving humans. Categories of publication include research articles, reviews, editorials, commentaries, and correspondence. All material is peer-reviewed.
We aim to disseminate knowledge about diabetes research with the goal of improving the management of people with diabetes. The journal therefore seeks to provide a forum for the exchange of ideas between clinicians and researchers worldwide. Topics covered are of importance to all healthcare professionals working with people with diabetes, whether in primary care or specialist services.
Surplus generated from the sale of Diabetic Medicine is used by Diabetes UK to know diabetes better and fight diabetes more effectively on behalf of all people affected by and at risk of diabetes as well as their families and carers.”
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