Evaluating diabetes-specific meal replacements for glycaemic control in overweight and obese patients with T2DM: a protocol for a randomised controlled trial
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 82 participants or records.
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