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

NCT07748949 | Recruiting DMC

• 3 other identifiers: 0890/68Ratchadapiseksompotch FundRCPT
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetes remission; Type 2 Diabetes; Obesity; Lifestyle intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (7)

• Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at ุ6 months

  6 months

• Change in HbA1c from baseline to 3 and 6 months

  3 and 6 months

• Change in body mass index (BMI) from baseline to 3 and 6 months

  3 and 6 months

• Change in waist circumference from baseline to 3 and 6 months

  3 and 6 months

• Change in fat mass from baseline to 3 and 6 months

  3 and 6 months

Other Outcomes (1)

• Change in 36-Item Short Form Health Survey (SF-36) score from baseline to 3 and 6 months

  3 and 6 months

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Standard diabetes care with routine clinical visits every 3 months.

Other: Standard Care (in control arm)

Low-calorie diet with intensive lifestyle intervention using iPDM

EXPERIMENTAL

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; Device: Continous Glucose Monitor (CGM); Behavioral: Personalized exercise program

Interventions

Low-calorie diet BEHAVIORAL

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.

Low-calorie diet with intensive lifestyle intervention using iPDM

Continous Glucose Monitor (CGM) DEVICE

Real-Time Continuous Glucose Monitoring

Low-calorie diet with intensive lifestyle intervention using iPDM

Standard Care (in control arm) OTHER

Standard diabetes care with routine clinical visits every 3 months.

Standard care

Personalized exercise program BEHAVIORAL

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.

Low-calorie diet with intensive lifestyle intervention using iPDM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulalongkorn University: lead
• Ratchadapiseksompotch Fund: collaborator
• The Royal College of Physicians of Thailand: collaborator

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

RECRUITING

Related Publications (10)

• Ehrhardt N, Al Zaghal E. Continuous Glucose Monitoring As a Behavior Modification Tool. Clin Diabetes. 2020 Apr;38(2):126-131. doi: 10.2337/cd19-0037.

  PMID: 32327884 BACKGROUND

• Look AHEAD Research Group; Wing RR, Bolin P, Brancati FL, Bray GA, Clark JM, Coday M, Crow RS, Curtis JM, Egan CM, Espeland MA, Evans M, Foreyt JP, Ghazarian S, Gregg EW, Harrison B, Hazuda HP, Hill JO, Horton ES, Hubbard VS, Jakicic JM, Jeffery RW, Johnson KC, Kahn SE, Kitabchi AE, Knowler WC, Lewis CE, Maschak-Carey BJ, Montez MG, Murillo A, Nathan DM, Patricio J, Peters A, Pi-Sunyer X, Pownall H, Reboussin D, Regensteiner JG, Rickman AD, Ryan DH, Safford M, Wadden TA, Wagenknecht LE, West DS, Williamson DF, Yanovski SZ. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013 Jul 11;369(2):145-54. doi: 10.1056/NEJMoa1212914. Epub 2013 Jun 24.

  PMID: 23796131 BACKGROUND

• Gregg EW, Chen H, Bancks MP, Manalac R, Maruthur N, Munshi M, Wing R; Look AHEAD Research Group. Impact of remission from type 2 diabetes on long-term health outcomes: findings from the Look AHEAD study. Diabetologia. 2024 Mar;67(3):459-469. doi: 10.1007/s00125-023-06048-6. Epub 2024 Jan 18.

  PMID: 38233592 BACKGROUND

• Lim EL, Hollingsworth KG, Aribisala BS, Chen MJ, Mathers JC, Taylor R. Reversal of type 2 diabetes: normalisation of beta cell function in association with decreased pancreas and liver triacylglycerol. Diabetologia. 2011 Oct;54(10):2506-14. doi: 10.1007/s00125-011-2204-7. Epub 2011 Jun 9.

  PMID: 21656330 BACKGROUND

• Umphonsathien M, Prutanopajai P, Aiam-O-Ran J, Thararoop T, Karin A, Kanjanapha C, Jiamjarasrangsi W, Khovidhunkit W. Immediate and long-term effects of a very-low-calorie diet on diabetes remission and glycemic control in obese Thai patients with type 2 diabetes mellitus. Food Sci Nutr. 2019 Feb 11;7(3):1113-1122. doi: 10.1002/fsn3.956. eCollection 2019 Mar.

  PMID: 30918654 BACKGROUND

• Guldemond N. What is meant by 'integrated personalized diabetes management': A view into the future and what success should look like. Diabetes Obes Metab. 2024 Mar;26 Suppl 1:14-29. doi: 10.1111/dom.15476. Epub 2024 Feb 8.

  PMID: 38328815 BACKGROUND

• Sattar N, Welsh P, Leslie WS, Thom G, McCombie L, Brosnahan N, Richardson J, Gill JMR, Crawford L, Lean MEJ. Dietary weight-management for type 2 diabetes remissions in South Asians: the South Asian diabetes remission randomised trial for proof-of-concept and feasibility (STANDby). Lancet Reg Health Southeast Asia. 2023 Feb;9:100111. doi: 10.1016/j.lansea.2022.100111.

  PMID: 36777452 BACKGROUND

• Taheri S, Zaghloul H, Chagoury O, Elhadad S, Ahmed SH, El Khatib N, Amona RA, El Nahas K, Suleiman N, Alnaama A, Al-Hamaq A, Charlson M, Wells MT, Al-Abdulla S, Abou-Samra AB. Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):477-489. doi: 10.1016/S2213-8587(20)30117-0.

  PMID: 32445735 BACKGROUND

• Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.

  PMID: 29221645 BACKGROUND

• Taylor R, Holman RR. Normal weight individuals who develop type 2 diabetes: the personal fat threshold. Clin Sci (Lond). 2015 Apr;128(7):405-10. doi: 10.1042/CS20140553.

  PMID: 25515001 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight

Interventions

Caloric Restriction; Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Primploy Greeviroj, M.D., M.S.c.

CONTACT

+66917142555; primploy.gre@chulahospital.org

Nuttapatch Kaoean, M.D.

CONTACT

+66817227133; nuttapatch.kaoean@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized control trial

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 6, 2026
• Study Start: June 17, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

TH (1)