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.
Diagnosed with type 2 diabetes mellitus with HbA1c level of 6.0 to 9.0%. Participants with HbA1c of 6.0 to 6.4% were required to be receiving oral glucose lowering medication.
Diagnosed with type 2 diabetes mellitus for less than 6 years.
Body mass index of 23 kg/m2 or greater.
Receiving more than two oral glucose-lowering medications.
Receiving insulin therapy.
Use of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) within 3 months before study enrollment.
Use of medications known to affect HbA1c within 3 months before study enrollment, including corticosteroids, vitamin C (excluding vitamin C obtained from natural dietary sources or fruits), vitamin E, trimethoprim-sulfamethoxazole, or hydroxyurea.
Parallel
Low-calorie diet
BehavioralParticipants in the intervention group will receive a Thai food-based low-calorie diet consisting of two meal replacements per day, combined with individualized dietary counseling to achieve a total daily energy intake of ≤1,200 kcal/day during the 3-month intensive phase. During the subsequent 3-month maintenance phase, participants will transition to a Thai food-based energy-controlled diet with reinforcement of behavioral modification strategies and nutritional education delivered via telemedicine every 4 weeks, with a recommended total daily energy intake of ≤1,500 kcal/day.
Continous Glucose Monitor (CGM)
DeviceReal-Time Continuous Glucose Monitoring
Standard Care (in control arm)
Other interventionStandard diabetes care with routine clinical visits every 3 months.
Personalized exercise program
BehavioralThe exercise intervention is individualized according to the FITT (Frequency, Intensity, Time, and Type) principles for adults with type 2 diabetes mellitus. Baseline cardiorespiratory fitness is assessed using the YMCA 3-Minute Step Test. Heart rate recovery following the test is used to classify participants' fitness level and determine their initial exercise prescription. Exercise intensity is subsequently individualized and progressively adjusted using the Rating of Perceived Exertion (RPE) and/or heart rate monitoring to ensure safe and effective progression throughout the intervention.
Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at 3 months
To evaluate the effectiveness of a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM), compared with standard diabetes care, in achieving diabetes remission at 3 months in adults with type 2 diabetes mellitus. Diabetes remission is defined as an HbA1c level \<6.5% at least 3 months in the absence of usual glucose-lowering pharmacotherapy.
Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at ุ6 months
To evaluate the effectiveness of a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM), compared with standard diabetes care, in achieving diabetes remission at 6 months in adults with type 2 diabetes mellitus. Diabetes remission is defined as an HbA1c level \<6.5% at least 3 months in the absence of usual glucose-lowering pharmacotherapy.
Change in HbA1c from baseline to 3 and 6 months
To evaluate the effectiveness of a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM), compared with standard diabetes care, on changes in HbA1c in adults with type 2 diabetes mellitus.
Change in body mass index (BMI) from baseline to 3 and 6 months
To evaluate the effectiveness of a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM), compared with standard diabetes care, on change in BMI in adults with type 2 diabetes mellitus. BMI is calculated from measured body weight and height and reported in kilograms per square meter (kg/m²).
Change in waist circumference from baseline to 3 and 6 months
To evaluate the effectiveness of a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM), compared with standard diabetes care, on change in waist circumference in adults with type 2 diabetes mellitus.
Change in 36-Item Short Form Health Survey (SF-36) score from baseline to 3 and 6 months
To evaluate the effectiveness of a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM), compared with standard diabetes care, on quality of life in adults with type 2 diabetes mellitus. To evaluate the effectiveness of a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM), compared with standard diabetes care, on health-related quality of life in adults with type 2 diabetes mellitus, as assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 consists of eight domain scores, each ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Click on the lead sponsor to view all of their trials.
Chulalongkorn University
Lead sponsor
Ratchadapiseksompotch Fund
Collaborator
The Royal College of Physicians of Thailand
Collaborator
