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

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.

Conditions

• Type 2 Diabetes
• Obesity & Overweight
• Remission
• Lifestyle Intervention

Interventions

BEHAVIORAL

Low-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.

DEVICE

Continous Glucose Monitor (CGM)

Real-Time Continuous Glucose Monitoring

OTHER

Standard Care (in control arm)

Standard diabetes care with routine clinical visits every 3 months.

BEHAVIORAL

Personalized 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.

Sponsors & Collaborators

• Ratchadapiseksompotch Fund

  collaborator UNKNOWN

• The Royal College of Physicians of Thailand

  collaborator UNKNOWN

• Chulalongkorn University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-17

Primary Completion

2027-04-30

Completion

2027-07-31

Countries

• Thailand

Study Locations