Evaluating Diabetes-Specific Meal Replacements for Glycaemic Control in Overweight and Obese Patients with T2DM

A new study from Universiti Kebangsaan Malaysia aims to evaluate the efficacy of diabetes-specific meal replacements for glycaemic control in overweight and obese patients with type 2 diabetes mellitus (T2DM). The researchers plan to conduct a randomised controlled trial to assess the impact of meal replacement therapy on weight loss, glycaemic control, satiety, quality of life, metabolic gene expression, and cost benefit in patients with T2DM. The study will involve 164 participants who will be randomly assigned to either an intervention group receiving meal replacements or a control group receiving dietary counselling alone.

Key Takeaways:

  • The study aims to evaluate the efficacy of diabetes-specific meal replacements for glycaemic control in overweight and obese patients with T2DM.
  • The researchers will conduct a randomised controlled trial involving 164 participants with T2DM.
  • The study will assess the impact of meal replacement therapy on weight loss, glycaemic control, satiety, quality of life, metabolic gene expression, and cost benefit.
  • Participants will receive dietary counselling and meal replacements (intervention group) or dietary counselling alone (control group) for 12 weeks.
  • The study's main outcomes will include glycaemic control and obesity indicators, while secondary outcomes will include cardiovascular disease risk markers, metabolic risk, metabolic gene profile analysis, dietary data, physical activity, satiety level, quality of life, and cost analysis.
  • The study will collect baseline data on 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, with measurements including anthropometry, blood pressure, diet, physical activity, and satiety level.
  • Individuals consuming less than 80% of the meal replacements will be deemed non-compliant.
  • Statistical analyses will be conducted using IBM SPSS V.29.0 software with a significance level of p.

Statistics:

  • 164 participants will be involved in the study (intervention group: n=82, control group: n=82).
  • The study will assess the impact of meal replacement therapy on weight loss, glycaemic control, satiety, quality of life, metabolic gene expression, and cost benefit.
  • The study will collect data on sociodemographics, anthropometry, blood pressure, diet, physical activity, satiety level, quality of life, blood profile, metabolic gene expression profile, and cost-benefit analysis at baseline and follow-up.
  • The study's main outcomes will include glycaemic control and obesity indicators.

Sources:

  • NewsRx. Researchers at Universiti Kebangsaan Malaysia Target Obesity and Diabetes (Evaluating diabetes-specific meal replacements for glycaemic control in overweight and obese patients with T2DM: a protocol for a randomised controlled trial). Clinical Trials Week. October 20, 2025; p 136.
  • Evaluating diabetes-specific meal replacements for glycaemic control in overweight and obese patients with T2DM: a protocol for a randomised controlled trial. BMJ Open, 2025;15(10).