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 (REMIT-DM)

July 31, 2026 updated by: Chulalongkorn University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • King Chulalongkorn Memorial Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Primploy Greeviroj, M.D., M.S.c.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • History of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.
  • Unstable psychiatric disorders within the previous 2 years, including major depressive disorder, bipolar disorder, or schizophrenia.
  • Pregnant or breastfeeding women, or women planning to become pregnant within 12 months.
  • Presence of any of the following medical conditions based on medical history and clinical records, including chronic kidney disease with an estimated glomerular filtration rate less than 45 mL/min/1.73 m2, liver cirrhosis or hepatitis with alanine aminotransferase or aspartate aminotransferase more than 3 times the upper limit of normal, chronic alcohol abuse, hypothyroidism with thyroid-stimulating hormone more than 10 uIU/mL, HIV infection, anemia (hemoglobin less than 10 g/dL), iron deficiency, vitamin B12 deficiency, folate deficiency, thalassemia, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia, or hemoglobin more than 16 g/dL, heart failure or ischemic heart disease within the previous 6 months.
  • History of blood donation or blood transfusion within the previous 3 months.
  • Uncontrolled diabetic retinopathy or other uncontrolled retinal disease, including maculopathy, based on medical records.
  • Signs, symptoms, or a history of malignancy within 5 years before screening, except for basal cell carcinoma, squamous cell carcinoma of the skin, or other carcinoma in situ.
  • Major surgery within 90 days before enrollment or planned major surgery within 6 months after enrollment.
  • No access to a smartphone capable of supporting the study application and internet-based data transmission.
  • Unable to maintain communication with the study investigators according to the study protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard care
Standard diabetes care with routine clinical visits every 3 months.
Other: Standard Care (in control arm)
Standard diabetes care with routine clinical visits every 3 months.
Experimental: Low-calorie diet with intensive lifestyle intervention using iPDM
A low-calorie diet consisting of two meal replacements per day, with total daily energy intake restricted to no more than 1,200 kcal/day, will be provided together with a personalized exercise program, continuous glucose monitoring (CGM), and lifestyle counseling delivered via telemedicine every 2 weeks throughout the initial 3-month intensive phase. This will be followed by behavioral modification reinforcement and nutritional education delivered via telemedicine every 4 weeks during the subsequent 3-month maintenance phase, with a recommended total daily energy intake of no more than 1,500 kcal/day.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at 3 months
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at ุ6 months
Time Frame: 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.
6 months
Change in HbA1c from baseline to 3 and 6 months
Time Frame: 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.
3 and 6 months
Change in body mass index (BMI) from baseline to 3 and 6 months
Time Frame: 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).
3 and 6 months
Change in waist circumference from baseline to 3 and 6 months
Time Frame: 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.
3 and 6 months
Change in fat mass from baseline to 3 and 6 months
Time Frame: 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 fat mass in adults with type 2 diabetes mellitus, as assessed using bioelectrical impedance analysis (BIA) and reported in kilograms (kg).
3 and 6 months
Change in skeletal muscle mass from baseline to 3 and 6 months
Time Frame: 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 skeletal muscle mass in adults with type 2 diabetes mellitus, as assessed using bioelectrical impedance analysis (BIA) and reported in kilograms (kg).
3 and 6 months
Change in Time in Range from baseline to 3 months
Time Frame: 3 months
To evaluate the effectiveness of a low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM) on changes in Time in Range (TIR), as measured by continuous glucose monitoring (CGM), in adults with type 2 diabetes mellitus.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 36-Item Short Form Health Survey (SF-36) score from baseline to 3 and 6 months
Time Frame: 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.
3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Collaborators

The Royal College of Physicians of Thailand
Ratchadapiseksompotch Fund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

July 26, 2026

First Submitted That Met QC Criteria

July 31, 2026

First Posted (Actual)

August 6, 2026

Study Record Updates

Last Update Posted (Actual)

August 6, 2026

Last Update Submitted That Met QC Criteria

July 31, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0890/68
  • Ratchadapiseksompotch Fund (Other Grant/Funding Number: GA69/095)
  • RCPT (Other Grant/Funding Number: 06/2568)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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