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

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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.