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 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
54
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Primploy Greeviroj, M.D., M.S.c.
- Número de telefone: +66917142555
- E-mail: primploy.gre@chulahospital.org
Estude backup de contato
- Nome: Nuttapatch Kaoean, M.D.
- Número de telefone: +66817227133
- E-mail: nuttapatch.kaoean@gmail.com
Locais de estudo
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Bangkok, Tailândia, 10330
- Recrutamento
- King Chulalongkorn Memorial Hospital
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Contato:
- Primploy Greeviroj, M.D., M.S.c.
- Número de telefone: +66917142555
- E-mail: primploy.gre@chulahospital.org
-
Contato:
- Nuttapatch Kaoean, M.D.
- Número de telefone: +66817227133
- E-mail: nuttapatch.kaoean@gmail.com
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Investigador principal:
- Primploy Greeviroj, M.D., M.S.c.
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Standard care
Standard diabetes care with routine clinical visits every 3 months.
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Standard diabetes care with routine clinical visits every 3 months.
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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.
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at 3 months
Prazo: 3 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, 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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of participants achieving diabetes remission based on HbA1c <6.5% without glucose-lowering medication at ุ6 months
Prazo: 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, 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
Prazo: 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 changes in HbA1c in adults with type 2 diabetes mellitus.
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3 and 6 months
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Change in body mass index (BMI) from baseline to 3 and 6 months
Prazo: 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 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
Prazo: 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
Prazo: 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 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
Prazo: 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 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
Prazo: 3 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) on changes in Time in Range (TIR), as measured by continuous glucose monitoring (CGM), in adults with type 2 diabetes mellitus.
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3 months
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in 36-Item Short Form Health Survey (SF-36) score from baseline to 3 and 6 months
Prazo: 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 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
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
17 de junho de 2026
Conclusão Primária (Estimado)
30 de abril de 2027
Conclusão do estudo (Estimado)
31 de julho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
26 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
31 de julho de 2026
Primeira postagem (Real)
6 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Distúrbios Nutricionais
- Doenças Metabólicas
- Supernutrição
- Peso corporal
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Excesso de peso
- Obesidade
- Diabetes Mellitus, Tipo 2
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Terapêutica
- Qualidade de assistência médica
- Dieta, comida e nutrição
- Fenômenos fisiológicos
- Indicadores de qualidade, assistência médica
- Fenômenos fisiológicos nutricionais
- Dieta terapia
- Terapia nutricional
- Dieta
- Ingestão de energia
- Padrão de atendimento
- Restrição calórica
Outros números de identificação do estudo
- 0890/68
- Ratchadapiseksompotch Fund (Número de outro subsídio/financiamento: GA69/095)
- RCPT (Número de outro subsídio/financiamento: 06/2568)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .