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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chulalongkorn University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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