RecruitingNot ApplicableNCT07748949

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

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: A Randomized Controlled Trial


Sponsor

Chulalongkorn University

Enrollment

54 participants

Start Date

Jun 17, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Continous Glucose Monitor (CGM), a behavioral approach called Low-calorie diet, and others for people with lifestyle intervention, obesity, overweight, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALLow-calorie diet

Participants 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.

DEVICEContinous Glucose Monitor (CGM)

Real-Time Continuous Glucose Monitoring

OTHERStandard Care (in control arm)

Standard diabetes care with routine clinical visits every 3 months.

BEHAVIORALPersonalized exercise program

The 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.


Locations(1)

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

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NCT07748949


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