Efficacy and Safety of Meal Replacement in Patients With Type 2 Diabetes

Abstract Context Meal replacement (MR) is beneficial for the management of type 2 diabetes (T2D). However, MR prescription and patient characteristics vary substantially between studies using MR in T2D patients. Objective This work aimed to evaluate the efficacy and safety of MR in T2D patients by meta-analysis, with a focus on subgroup analysis of variable participant characteristics and MR prescription. Methods We searched PubMed, CENTRAL, Embase, Web of Science, and the clinical trial registration database up to March 2022. We included randomized controlled trials (RCTs) of 2 weeks or more assessing the effect and safety of MR in T2D patients in comparison with conventional diabetic diets (CDs). Results A total of 17 RCTs involving 2112 participants were ultimately included. Compared with CDs, MR significantly reduced glycated hemoglobin A1c (HbA1c) (MD −0.46%; P < .001), fasting blood glucose (FBG, −0.62 mmol/L; P < .001), body weight (−2.43 kg; P < .001), and body mass index (BMI, −0.65; P < .001), and improved other cardiometabolic risk factors. In subgroup analyses, total MR showed greater improvement in HbA1c (−0.72% vs −0.32%; P = .01), FBG (−1.45 vs −0.56 mmol/L; P = .02), body weight (−6.57 vs −1.58 kg; P < .001), and BMI (−2.78 vs −0.37; P < .001) than partial MR. MR with caloric restriction showed more reduction in body weight (−3.20 vs −0.75 kg; P < .001) and BMI (−0.84 vs −0.24; P = .003) compared with those without caloric restriction. MR showed similar benefits in studies that included patients using insulin and those that did not. Both partial and total MR were well tolerated. Conclusion Compared with CDs, the MR-based dietary pattern further improved the glycemic control and adipose indicators in T2D patients. Appropriate calorie restriction and total MR might be more beneficial, while both patients treated with or without insulin treatment could similarly benefit from MR usage.