The RESET 4 REMISSION Trial
The RESET 4 REMISSION Trial investigates whether the combination of a low energy diet in conjunction with structured exercise training can lead to remission in young adults with Type 2 Diabetes (primary objective). Diabetes remission will be defined as achieving an HbA1c of less than 6.5% (48mmol/mol) without glucose lowering medication for 12 weeks or more
(24 week trial - remission to be obtained by week 12 and sustained).
This study will be ran in parallel between the UK and Canada, with total recruitment aimed at 80 participants (UK = 40/ Canada = 40), of which Control Group = 20 and Exercise/Dietary Intervention = 20. The intervention is scheduled for 24 weeks. We will be recruiting young adults (18 – 45 years old) who have recent onset of Type 2 Diabetes (diagnosed ≥3 months to ≤6 years).
Secondary outcome measures of interest include: MRI-defined measures of cardiac function/structure including circumferential peak early diastolic strain rate (diastolic function); peak VO2; visceral/hepatic fat (MRI); body composition, including lean body mass, blood pressure, including remission of hypertension; objectively assessed sleep, sedentary time and physical activity; depression, anxiety and quality of life; process evaluations for acceptability, feasibility, barriers and facilitators of the intervention.
The low energy diet component of the intervention will involve phased use of meal replacements and ongoing macronutrient/calorie targets. Meanwhile, the exercise component will involve a mixture of supervised and independent training (encompassing structured aerobic and resistance exercise).