RESET 4 Remission
Study title
Investigating 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
Funding and sponsorship
Leicester Lifestyle and Health Research Group
Background
Automated insulin delivery use in T2D shows success in helping adults achieve their glycaemic targets safely; however, the evidence so far is in older individuals, with no specific data available demonstrating the efficacy and safety of AID use in those with EOT2D. Individuals in Leicester with EOT2D who are already on MDI insulin regimes would highly benefit from diabetes technologies, starting with smart insulin pens with CGM, and ultimately AHCL therapy, especially given the high-risk population we have in Leicester as described above. Taking this into consideration, as well as our dedicated research interest in EOT2D, Leicester is the ideal site for studying the efficacy and safety of AHCL therapy in those with EOT2D.
This project will therefore assess the acceptability, usability and clinical benefits of AHCL therapy in adults with EOT2D in Leicester. As previous studies looking at AID use have been relatively short in duration, we will be studying AHCL use for a longer duration of 24 weeks.
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)
Study aims
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).
Study summary
Study progress
Closed
Study publications
N/A
Data Protection
Leicester Lifestyle & Health Research Group
For more information, please contact: mm636@leicester.ac.uk or 0116 258 4323