# Combining structured exercise with a low-energy diet to attenuate lean mass loss in South Asian adults living with type 2 diabetes: the COMBINE randomised trial protocol

## TL;DR

This study tests if adding exercise to a low-calorie diet helps South Asian adults with type 2 diabetes keep more lean mass while losing weight.

## Contribution

The study introduces a novel combination of structured exercise and a low-energy diet to preserve lean mass in an understudied South Asian population with type 2 diabetes.

## Key findings

- The trial will measure lean mass changes using dual-energy X-ray absorptiometry.
- Results will inform future effectiveness trials and health strategies for South Asian populations with diabetes.
- Findings will be shared through publications and public platforms to maximize impact.

## Abstract

The global prevalence of type 2 diabetes (T2D) is rising and disproportionately affects South Asian adults, including those in the United Kingdom. South Asians develop T2D at a higher rate and at a younger age than their white British counterparts, at a lower body mass index. Active efforts to reduce adiposity can improve glycaemic control and in some cases achieve T2D remission. However, a substantial proportion of lean mass is lost while achieving weight loss, which may have physiological and metabolic consequences, affecting long-term health outcomes and quality of life for people living with T2D and obesity. We are examining the impact of a combined low energy diet and supervised exercise intervention versus a low energy diet alone for the preservation of lean mass in an understudied South Asian population living with T2D and excess adiposity.

This prospective, randomised, two-arm parallel-group, open-label, blinded-endpoint trial is being conducted in Leicester, UK. 36 South Asian adults aged 40–65 years within 10 years of T2D diagnosis and not on insulin therapy will be enrolled. Both intervention arms will receive an 800–900 kcal/day low energy diet for 12 weeks. Those randomised to the exercise group will additionally receive a mixture of supervised and home-based resistance and aerobic exercise training three times per week. The primary outcome is the difference in the change of lean mass between groups measured using dual-energy X-ray absorptiometry at baseline and 12 weeks and will be analysed using linear regression modelling.

The trial was approved by the NHS research ethics service (23/WM/0201). All participants will provide informed consent prior to enrolment, and the study will be conducted in accordance with the Declaration of Helsinki. Findings will be shared widely (publications, presentations, press releases, social media platforms) and will inform an effectiveness trial.

ISRCTN11175684.