Evaluating diabetes-specific meal replacements for glycaemic control in overweight and obese patients with T2DM: a protocol for a randomised controlled trial.

INTRODUCTION: Uncontrolled type 2 diabetes mellitus (T2DM) causes microvascular and macrovascular issues that hike healthcare costs and threaten global health. Previous studies have suggested meal replacement (MR) therapy for T2DM, but there were inconsistencies in the results. Thus, a randomised controlled trial is proposed to determine the efficacy of a diabetes-specific MR product on weight loss, glycaemic control, satiety, quality of life, metabolic gene expression and cost benefit in overweight and obese patients with T2DM. METHODS AND ANALYSIS: 164 overweight and obese participants with T2DM will be randomly assigned to either an intervention group (n=82) or a control group (n=82). All participants will receive dietary counselling; however, only the intervention group will receive MR for 12 weeks. Glycaemic control and obesity indicators are the study's main outcomes. Secondary outcomes include cardiovascular disease risk markers, metabolic risk, metabolic gene profile analysis, dietary data, physical activity, satiety level, quality of life and cost analysis. Baseline data will include sociodemographics, anthropometry, blood pressure, diet, physical activity, satiety level, quality of life, blood profile, metabolic gene expression profile and cost-benefit analysis. A follow-up is planned at intervention weeks 6 and 12. Week 6 will assess only anthropometry, blood pressure, diet, physical activity and satiety level. For compliance assessment, intervention group participants will bring their MR container. Week 12 will measure the same baseline parameter, except sociodemographic data. Individuals who consume less than 80% of the MR will be deemed non-compliant. All parameter modifications will be documented and analysed for comparison. All statistical analyses will be conducted using IBM SPSS V.29.0 software, with a significance level of p<0.05. The cost-benefit analysis will be determined using the net present value. ETHICS AND DISSEMINATION: This research protocol was approved by the Ethical Committee of the National University of Malaysia (JEP-2024-695) and registered on International Standard Randomised Controlled Trial Number. Study findings will be disseminated in peer-reviewed journals, conference presentations and social media. TRIAL REGISTRATION NUMBER: ISRCTN57040303).