A Multicentre Open-Label, Feasibility Study Of The Use Of A Short-Term Low-Energy Diet In Adolescents With Obesity And Type 2 Diabetes Mellitus

The number of under-18s with type 2 diabetes (T2DM) is rising alongside childhood obesity. It has a worse prognosis than type 1 diabetes at the same age. Serious medical problems occur sooner and progress more quickly. These include renal failure, nerve damage and blindness. Guidelines recommend children and families are supported to eat healthily and increase activity. Low-calorie diets are effective in reversing T2DM in half of adults who lost 10-15 kg, by reduction of liver and pancreatic fat. Remission of T2DM results in improved quality of life and life expectancy for patients with large cost-savings for the NHS. Locally, we have worked with eight young people who lost 10kg on average. This study will find out if a low-calorie diet is acceptable to under-18s with type 2 diabetes (T2DM). The low-calorie diet provides 800-1000kcal a day (with LED diets typically containing 800-1200kcal/day). The participant has special soups and shakes instead of their usual meals for several weeks. Participants can have a low-calorie meal each day instead of a meal replacement product at the study teams discretion. The young person’s own hospital team will carry out the study. This study aims to find out: To estimate recruitment and retention rates to inform a full randomised control trial of an LED for adolescents with T2DM. To understand what the barriers and motivators are and how to optimise them. To provide estimates of the weight loss needed to achieve remission. To understand the positive and potential negative effects of a period of LED on the biological, psychological and social wellbeing of adolescents. To identify pathways involved in the pathogenesis of T2DM in young people and prognostic markers of disease progression or response to intervention. We will use the findings to plan a larger trial.