Evaluating Diabetes-Specific Meal Replacements for Glycaemic Control in Overweight and Obese T2DM Patients: A Protocol for a Randomized Controlled Trial

Introduction

Uncontrolled Type 2 diabetes mellitus (T2DM) causes micro- and macrovascular issues that hike healthcare costs and threaten global health. Previous studies suggested meal replacement (MR) therapy for T2DM, but there were inconsistencies in the results. Thus, an RCT 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 T2DM patients.

Methods and analysis

164 overweight and obese T2DM participants 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 marker, metabolic risk, metabolic gene profile analysis, dietary data, physical activity, satiety level, quality of life, and cost analysis. Baseline data will include socio-demographics, anthropometry, blood pressure, diet, physical activity, satiety level, quality of life, blood profile, metabolic gene expression profile, and cost-benefit analysis. 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 socio-demographic data. Individuals that 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 version 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 National University of Malaysia (JEP-2024-695) and registered on International Standard Randomised Controlled Trial Number ( ISRCTN57040303 ).

STRENGTHS AND LIMITATION OF THIS STUDY

• This study addresses multiple outcomes related to T2DM management, including weight reduction, glycaemic control, blood pressure, satiety level, quality of life, and metabolic gene expression, providing a holistic view of the intervention’s efficacy.

• Incorporating a cost-benefit analysis will add on a practical value by evaluating the economic feasibility of the intervention, which is essential for real-world application and healthcare policy-making.

• Since this study will investigate the effect of the partial diabetes-specific meal replacement on changes in metabolic gene expression, it will provide insights into the molecular mechanisms underlying the intervention’s effects.

• A primary limitation of the study is the absence of a placebo group and the fact it is not double blinded

• This trial is a single-centred study that is limited to the Malaysian T2DM population that visit the public health sector.