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

标题：通过低热量饮食和监督运动来逆转2型糖尿病问题是什么？2型糖尿病正变得越来越普遍，而且成年人患得更早（年龄在18-40岁之间）。这是令人担忧的，因为早得2型糖尿病的人很可能在年轻时就有心脏、肾脏和身体功能问题。然而，许多这些影响已经被证明是可逆的，要么通过低热量饮食引起的体重减轻，要么通过有组织的锻炼。然而，我们不知道减肥和运动相结合是否会给年轻的2型糖尿病患者带来更大的改善。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，已经表明低热量饮食导致超过一半的人逆转了他们的2型糖尿病。尽管如此，我们已经证明心脏的结构和功能没有变化。另一方面，12周的有组织的锻炼改善了心脏的泵血功能。我们要做什么？RESET项目的总体目标是组建一个由营养、运动、心脏病和糖尿病专家组成的团队，他们将与我们的患者合作伙伴一起，调查与标准治疗相比，有组织的运动计划和低卡路里饮食的结合是否能逆转糖尿病，改善心脏功能、健康和其他健康方面。我们该怎么做呢？总共有80人将被随机分配到：通常的标准治疗组或运动计划和低卡路里饮食的组合组。标准治疗-这一组将接受正常的糖尿病治疗，并将提供一份概述饮食和运动益处的传单。在试验结束时，他们还将获得低卡路里饮食。低热量饮食和锻炼——这些参与者在两周内接受奶昔代替所有正餐，然后在10周内每天只吃一餐。12周后，参与者将慢慢恢复正常饮食。在24周内，参与者将定期与营养师和研究医生联系。在运动专家的监督下，参与者每周也将参加三次运动（从第3周到第12周）。他们将使用跑步机、自行车、举重和阻力带。每次锻炼的时间将逐渐增加到60分钟。在剩下的12周（第13-24周），他们将被鼓励继续定期锻炼，但这不会受到直接监督。参与者仍然可以免费使用运动器材，并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，他们将被邀请回来接受监督训练。在锻炼的日子里，额外的卡路里将被允许用来补偿额外消耗的能量。我们测量的是什么?我们将观察有多少人在24周内逆转了他们的2型糖尿病。这意味着在不服用糖尿病药物的情况下将血糖水平恢复到正常范围。我们还将通过对心脏结构和泵送功能的详细扫描来观察心脏的变化。此外，我们还将测量健康、身体功能、脂肪和肌肉的数量，以及情绪或生活质量是否有任何变化。我们将包括谁？年龄在18-40岁之间，患有2型糖尿病3个月至6年的成年人，被归类为体重超过通常对健康有益的体重。参与者应该服用药片（而不是胰岛素）治疗他们的糖尿病。我们该怎么处理结果呢？我们将与参与者、公众和卫生保健提供者分享我们的结果。如果这项研究成功，它将导致另一项研究，将饮食加运动的方法与单独饮食的方法进行比较。我们还将研究如何在研究性学习之外提供该课程。

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.