Efficacy of diabetes-specific partial meal replacement on glycemic and weight control in type 2 diabetes: A randomized controlled trial

Aims: To evaluate the efficacy of a diabetes-specific formula (DSF)-based partial meal replacement (PMR) in improving glycemic control, weight, and underlying hormonal changes among participants with type 2 diabetes and overweight or obesity compared to dietary consultation. Materials and Methods: This 12-week, parallel randomized controlled trial was conducted at Hospital Canselor Tuanku Muhriz, National University of Malaysia, from February 2022 to March 2024. Adults aged 20-65 years with type 2 diabetes [haemoglobin A1c (HbA1c) >= 7.5%] and overweight or obesity were randomized into two groups: PMR with DSF (Metabolic+ Sauver) plus dietary consultation (treatment group) or dietary consultation alone (control group). The primary endpoint was mean change in HbA1c at week 12. Results: Among 156 participants (mean age 52.2 +/- 9.7 years), 141 completed the 12-week intervention. The treatment group had a greater HbA1c reduction compared to controls (-0.83% vs. -0.19%; MD: -0.63%; 95% CI: -1.00, -0.27; p < 0.001). A significantly higher proportion of the treatment group participants (61.4%) achieved clinically significant HbA1c reduction (>= 0.5%) compared to controls (42.3%, p = 0.023). Fasting glucose, insulin, and anthropometric measurements also significantly improved in the treatment group compared to controls. Subsample analysis on hormonal changes revealed significant improvements in adiponectin levels among the treatment group. Conclusion: This study demonstrated that PMR with DSF significantly improved glycemic and weight management in participants with type 2 diabetes and overweight or obesity. Adiponectin levels increased in the treatment group, correlating with improved glycemic control. No adverse events were observed on liver and kidney profiles, highlighting its potential as a safe and effective approach for diabetes management.