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)
31 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
54
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Primploy Greeviroj, M.D., M.S.c.
- Telefonnummer: +66917142555
- E-post: primploy.gre@chulahospital.org
Studera Kontakt Backup
- Namn: Nuttapatch Kaoean, M.D.
- Telefonnummer: +66817227133
- E-post: nuttapatch.kaoean@gmail.com
Studieorter
-
-
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Bangkok, Thailand, 10330
- Rekrytering
- King Chulalongkorn Memorial Hospital
-
Kontakt:
- Primploy Greeviroj, M.D., M.S.c.
- Telefonnummer: +66917142555
- E-post: primploy.gre@chulahospital.org
-
Kontakt:
- Nuttapatch Kaoean, M.D.
- Telefonnummer: +66817227133
- E-post: nuttapatch.kaoean@gmail.com
-
Huvudutredare:
- Primploy Greeviroj, M.D., M.S.c.
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Standard care
Standard diabetes care with routine clinical visits every 3 months.
|
Standard diabetes care with routine clinical visits every 3 months.
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Experimentell: 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.
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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.
Real-Time Continuous Glucose Monitoring
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at 3 months
Tidsram: 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.
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3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at ุ6 months
Tidsram: 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.
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6 months
|
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Change in HbA1c from baseline to 3 and 6 months
Tidsram: 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
|
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Change in body mass index (BMI) from baseline to 3 and 6 months
Tidsram: 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).
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3 and 6 months
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Change in waist circumference from baseline to 3 and 6 months
Tidsram: 3 and 6 months
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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.
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3 and 6 months
|
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Change in fat mass from baseline to 3 and 6 months
Tidsram: 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).
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3 and 6 months
|
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Change in skeletal muscle mass from baseline to 3 and 6 months
Tidsram: 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).
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3 and 6 months
|
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Change in Time in Range from baseline to 3 months
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in 36-Item Short Form Health Survey (SF-36) score from baseline to 3 and 6 months
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
17 juni 2026
Primärt slutförande (Beräknad)
30 april 2027
Avslutad studie (Beräknad)
31 juli 2027
Studieregistreringsdatum
Först inskickad
26 juli 2026
Först inskickad som uppfyllde QC-kriterierna
31 juli 2026
Första postat (Faktisk)
6 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
6 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
31 juli 2026
Senast verifierad
1 juli 2026
Mer information
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Andra studie-ID-nummer
- 0890/68
- Ratchadapiseksompotch Fund (Annat bidrag/finansieringsnummer: GA69/095)
- RCPT (Annat bidrag/finansieringsnummer: 06/2568)
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