RESET: REmission of diabetes and improved diastolic function by combining Structured Exercise with meal replacemenT and food reintroduction.

重置：通过将结构化运动与代餐和重新引入食物相结合，缓解糖尿病并改善舒张功能。

• 批准号: MR/T031816/1
• 负责人: Thomas Yates
• 金额: $ 43.16万
• 依托单位: University of Leicester
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2020
• 资助国家: 英国
• 起止时间: 2020 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FT031816%2F1
• 关键词: RESET; REmission; diabetes; improved; diastolic

Lay title: Reversing type 2 diabetes through a low calorie diet and supervised exerciseWhat is the problem? Type 2 diabetes is becoming more common and adults are getting it earlier (aged between 18-40). This is worrying because people who get type 2 diabetes earlier are very likely to have heart, kidney and physical function problems at an early age. However, many of these effects have been shown to be reversible, either through weight loss caused by a low calorie diet or structured exercise. However, we don't know if combining weight loss and exercise leads to even greater improvements in young adults with type 2 diabetes. What have we done so far?Previous research, including by our group, have shown that low calorie diets lead to over half of people reversing their type 2 diabetes. Despite this, we have shown that there is no change in the structure or function of the heart. On the other hand, 12 weeks of structured exercise improved the pumping function of the heart. What are we going to do?The overall aim of the RESET programme is to assemble a team of experts in nutrition, exercise, heart disease and diabetes who, along with our patient partners, will investigate whether the combination of a structured exercise programme and a low calorie diet reverses diabetes and improves heart function, fitness, and other aspects of health when compared to standard care.How will we do it?In total, 80 people will be randomly assigned to: either usual standard care or a combination of an exercise programme and a low calorie diet.Standard care - This group will receive their normal diabetes care and will be provided with a leaflet outlining the benefits of diet and exercise. They will also be offered the low calorie diet at the end of the trial.Low calorie diet and exercise - These participants receive shakes that will replace all meals for two weeks and then all but one meal of the day for 10 weeks. After 12 weeks, participants will slowly return to their normal diet. The participants will have regular contact with the dietitian and study doctor throughout the 24 weeks.Under the supervision of an exercise specialist, participants will also take part in exercise three times each week (from week 3 to week 12). They will use a treadmill, bike, weights, and resistance bands. The time exercising at each session will gradually be increased up to 60 minutes. They will be encouraged to continue exercising regularly for the remaining 12 weeks (weeks 13-24), but this will not be directly supervised. Participants will still have free access to exercise equipment and will still stay in contact with the exercise specialist who will track their activity and heart rate remotely. If the amount of exercise reduces, they will be invited back for supervised sessions. Additional calories will be allowed on exercise days to compensate for the extra energy expended. What are we measuring?We will look at how many people reverse status their type 2 diabetes across the 24 weeks .This means returning their sugar levels to normal ranges whilst not being on diabetes medications. We will also look at changes in the heart by performing detailed scans of the heart's structure and pumping function. In addition we will also measure fitness, physical function, the amount of fat and muscle and whether there is any change in mood or quality of life. Who will we include?Adults aged 18-40 who have had type 2 diabetes for between 3 months and 6 years and are classed as having more weight than is generally good for health. Participants should be on tablet (but not insulin) treatment for their diabetes.What will we do with the results? We will share our results with participants, the public and health care providers. If the study is successful, it will lead to another study to compare the diet plus exercise approach to diet alone. We will also look at how we could deliver the programme beyond a research study.

外行标题：通过低热量饮食和监督锻炼逆转 2 型糖尿病，问题是什么？ 2 型糖尿病变得越来越普遍，成年人患此病的时间也越来越早（18-40 岁）。这令人担忧，因为较早患上2型糖尿病的人很可能在很小的时候就出现心脏、肾脏和身体机能问题。然而，许多这些影响已被证明是可逆的，可以通过低热量饮食或结构化运动来减轻体重。然而，我们不知道减肥和锻炼相结合是否能让患有 2 型糖尿病的年轻人得到更大的改善。到目前为止我们做了什么？之前的研究（包括我们小组的研究）表明，低热量饮食可以使超过一半的人逆转 2 型糖尿病。尽管如此，我们已经证明心脏的结构或功能没有变化。另一方面，12周的结构化运动改善了心脏的泵血功能。我们要做什么？RESET 计划的总体目标是组建一个由营养、运动、心脏病和糖尿病方面的专家组成的团队，他们将与我们的患者合作伙伴一起，研究与标准护理相比，结构化运动计划和低热量饮食的结合是否可以逆转糖尿病并改善心脏功能、健康和其他健康方面。我们将如何做？总共 80 人将被随机分配到： 标准护理 - 该群体将接受正常的糖尿病护理，并将获得概述饮食和运动益处的传单。试验结束时，他们还将接受低热量饮食。低热量饮食和锻炼——这些参与者接受奶昔，以代替两周内的所有膳食，然后在 10 周内代替一天中除一顿饭外的所有膳食。 12周后，参与者将慢慢恢复正常饮食。参与者将在整个24周内定期与营养师和研究医生联系。在运动专家的监督下，参与者还将每周参加3次运动（从第3周到​​第12周）。他们将使用跑步机、自行车、哑铃和阻力带。每次锻炼的时间将逐渐增加至60分钟。我们将鼓励他们在剩下的 12 周（第 13-24 周）内继续定期锻炼，但这不会受到直接监督。参与者仍然可以免费使用运动设备，并且仍然与运动专家保持联系，后者将远程跟踪他们的活动和心率。如果运动量减少，他们将被邀请回来参加监督课程。锻炼日将允许摄入额外的卡路里，以补偿消耗的额外能量。我们测量的是什么？我们将观察有多少人在 24 周内逆转了 2 型糖尿病的状态。这意味着他们的血糖水平在不服用糖尿病药物的情况下恢复到正常范围。我们还将通过对心脏结构和泵血功能进行详细扫描来观察心脏的变化。此外，我们还会测量健康状况、身体机能、脂肪和肌肉的数量以及情绪或生活质量是否有任何变化。我们将包括哪些人？年龄在 18 至 40 岁之间、患有 2 型糖尿病 3 个月至 6 年且体重超过一般健康水平的成年人。参与者应该接受片剂（而非胰岛素）治疗糖尿病。我们将如何处理结果？我们将与参与者、公众和医疗保健提供者分享我们的结果。如果这项研究成功，将引发另一项研究，以比较饮食加运动的方法与单独饮食的方法。我们还将研究如何在研究之外提供该计划。

项目成果

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.

• DOI: 10.1136/bmjopen-2022-063888
• 发表时间: 2022-09-21
• 期刊: BMJ open
• 影响因子: 2.9

Genome-wide association study of self-reported walking pace suggests beneficial effects of brisk walking on health and survival.

• DOI: 10.1038/s42003-020-01357-7
• 发表时间: 2020-10-30
• 期刊: Communications biology
• 影响因子: 5.9
• 作者: Timmins IR;Zaccardi F;Nelson CP;Franks PW;Yates T;Dudbridge F
• 通讯作者: Dudbridge F

Self-reported walking pace, polygenic risk scores and risk of coronary artery disease in UK biobank.

英国生物样本库中自我报告的步行速度、多基因风险评分和冠状动脉疾病风险。

• DOI: 10.1016/j.numecd.2022.08.021
• 发表时间: 2022
• 期刊: NMCD
• 作者: Zaccardi F