Effectiveness of a Low-Calorie Diet Combined With Intensive Lifestyle Intervention Using Integrated Personalized Diabetes Management for Achieving Diabetes Remission in Patients With Type 2 Diabetes Mellitus

Overview

The goal of this clinical trial is to determine whether a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM) is more effective than standard care in achieving diabetes remission in adults with overweight and type 2 diabetes mellitus. The study will also evaluate the effects of the intervention on metabolic and clinical outcomes associated with diabetes remission. The main questions it aims to answer are: * Does a low-calorie diet combined with intensive lifestyle intervention using iPDM increase the proportion of participants who achieve diabetes remission compared with standard care? * Does the intervention improve metabolic and patient-centered outcomes, including glycemic control, body weight, body composition, Time in Range (TIR) measured by continuous glucose monitoring (CGM), quality of life, and cost-effectiveness? Researchers will compare participants receiving a low-calorie diet combined with intensive lifestyle intervention using iPDM with participants receiving standard diabetes care to determine whether the intervention is more effective in achieving diabetes remission and improving metabolic health. Participants will: * Be randomly assigned to either the intervention group or the standard care group. * Attend study visits for assessments of diabetes-related clinical and metabolic outcomes throughout the 6-month study. * If assigned to the intervention group, consume two low-calorie meal replacements per day and follow an individualized meal plan providing no more than 1,200 kcal per day during the first 3 months (intensive phase), together with a personalized exercise program, continuous glucose monitoring (CGM), and lifestyle counseling delivered via telemedicine every 2 weeks. During the following 3 months (maintenance phase), continue lifestyle modification with reinforcement sessions delivered via telemedicine every 4 weeks while following a meal plan providing no more than 1,500 kcal per day.

Participants will be randomized into two groups using block of four Group A: Intervention Group B: Standard care Intervention group Phase 1: Intensive phase (Months 0-3) Month 0: Baseline assessment * Data collection * Demographics: sex, age, address, duration of diabetes, diabetes-related complications, comorbidities, current medications, drug/food allergies * Physical examination: body weight, height, waist circumference, blood pressure, pulse rate * Body composition analysis using bioelectrical impedance analysis (BIA) * Fasting plasma glucose (FPG) * Glycated hemoglobin (HbA1c) * Fasting insulin * Lipid profile * Serum creatinine and electrolytes * Liver function tests * Urinalysis and spot urine albumin-to-creatinine ratio (UACR) * Quality of life questionnaires: SF-36 and EQ-5D-5L * Self-management questionnaire: Patient Activation Measure 13 (PAM-13) * Mental health questionnaire: PHQ-2; if PHQ-2 ≥1, proceed with PHQ-9 * Education and support Structured diabetes remission education will be provided by certified diabetes educators, including physicians, nurses, dietitians, and exercise physiologists. * Continuous Glucose Monitoring (CGM) Participants will wear a real-time CGM device (LinX CGM) for 15 days. Physicians will review the data via the LinX application every two weeks through telehealth consultations. * Dietary intervention Participants will be provided with two low-calorie meals per day (400 kcal/meal; carb:protein:fat = 45:30:25) on Monday-Friday * Nutrition education Participants will learn to calculate daily caloric intake (target ≤1,200 kcal/day) and record food intake on Saturdays and Sundays. Dietitians will review logs via telehealth every 2 weeks. * Exercise program Participants will perform a 2-minute walk test and receive a personalized exercise plan. Exercise logs will be reviewed biweekly via telehealth with exercise physiologists. Month 1 * Physical examination: body weight, height, waist circumference, blood pressure, pulse rate * CGM for 15 days * Medication review and adjustment * Behavioral education reinforcement Month 2 * Physical examination: body weight, height, waist circumference, blood pressure, pulse rate * CGM for 15 days * Medication review and adjustment * Behavioral education reinforcement Month 3 * Physical examination: body weight, height, waist circumference, blood pressure, pulse rate * Body composition via BIA * Laboratory investigations: FPG, HbA1c, fasting insulin, Lipid profile, creatinine, electrolytes, liver function tests, urinalysis, UACR * Questionnaires: SF-36, EQ-5D-5L, PAM-13, and PHQ-2 (if PHQ-2 ≥1, proceed with PHQ-9) * Satisfaction and experience questionnaire regarding CGM use Phase 2: Maintenance Phase (Months 3-6) During this 3-month phase, health educators will reinforce behavioral strategies aimed at achieving diabetes remission, with a daily caloric intake target not exceeding 1,500 kcal. Participants' body weight will be monitored monthly via telehealth. Month 6: Final assessment * Physical examination: body weight, height, waist circumference, blood pressure, pulse rate * Body composition via BIA * Laboratory investigations: FPG, HbA1c, fasting insulin, Lipid profile, creatinine, electrolytes, liver function tests, urinalysis, UACR * Questionnaires: SF-36, EQ-5D-5L, PAM-13, and PHQ-2 (if PHQ-2 ≥1, proceed with PHQ-9) Standard care group Participants will undergo data collection and follow-up with physicians at months 0, 3, and 6, following standard diabetes care. They will also receive diabetes remission education from certified diabetes educators at month 0, and a behavioral reinforcement session with health educators at month 3, similar to the intervention group.