Lifestyle Program to Achieve Diabetes Remission in Malaysian Adults with Type 2 Diabetes Mellitus Including Total Diet Replacement and Food Reintroduction Phases Compared to Standard Care in a Randomised Controlled Study

What this Trial Is About

This research aims to evaluate the effectiveness of a structured lifestyle intervention to induce remission of Type 2 Diabetes Mellitus T2DM among Malaysian adults. It also assesses the feasibility of implementing this approach within Malaysian primary and specialist care settings and examines the economic impact through cost-effectiveness analysis from a societal perspective. The study compares intensive lifestyle intervention to usual clinical care, hypothesizing higher diabetes remission rates, greater weight loss, better blood sugar control, and improved cost-effectiveness for those receiving the intervention. The trial uses a randomized, wait-list-controlled design with two phases. In the first phase, participants are randomly assigned to either an immediate intervention group or a wait-list control group. The intervention group undergoes a total diet replacement TDR phase for 8 to 12 weeks with a low-calorie diet, followed by a food reintroduction phase lasting 12 to 16 weeks, and then a 24-week weight maintenance phase. The wait-list control group receives usual care for 24 weeks before crossing over to the intervention. Medical management includes careful medication withdrawal and reintroduction protocols to manage blood pressure and blood sugar levels. Participants attend face-to-face or virtual appointments and phone calls with dietitians throughout the study. They complete food records and consumption logs to monitor adherence. The study measures diabetes remission rates at 6 months as the primary outcome, with secondary outcomes including remission maintenance at 12 months, weight loss, insulin resistance, and pancreatic function. Safety is monitored through regular checks of blood pressure, symptoms, and blood glucose levels, with adverse events reported promptly. The total participation period includes initial intervention and follow-up phases lasting up to 12 months.

Remission of Diabetes With Lifestyle Intervention for Malaysian Patients