[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650682":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":41,"locations":51,"responsibleParty":70,"collaborators":72,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":28,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":54,"whyStopped":28,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Chulalongkorn University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard care","ACTIVE_COMPARATOR","Standard diabetes care with routine clinical visits every 3 months.",[13],"Other: Standard Care (in control arm)",{"label":15,"type":16,"description":17,"interventionNames":18},"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\u002Fday, 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\u002Fday.",[19,20,21],"Behavioral: Low-calorie diet","Device: Continous Glucose Monitor (CGM)","Behavioral: Personalized exercise program",[23,29,34,37],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"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\u002Fday 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\u002Fday.",[15],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DEVICE","Continous Glucose Monitor (CGM)","Real-Time Continuous Glucose Monitoring",[15],{"type":6,"name":35,"description":11,"armGroupLabels":36,"otherNames":28},"Standard Care (in control arm)",[9],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"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\u002For heart rate monitoring to ensure safe and effective progression throughout the intervention.",[15],[42,47],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Primploy Greeviroj, M.D., M.S.c.","CONTACT","+66917142555","primploy.gre@chulahospital.org",{"name":48,"role":44,"phone":49,"phoneExt":28,"email":50},"Nuttapatch Kaoean, M.D.","+66817227133","nuttapatch.kaoean@gmail.com",[52],{"facility":53,"status":54,"city":55,"state":28,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"King Chulalongkorn Memorial Hospital","RECRUITING","Bangkok","10330","Thailand","TH",{"type":60,"coordinates":61},"Point",[62,63],100.50144,13.75398,{"lat":63,"lon":62},[66,67,68],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},{"name":48,"role":44,"phone":49,"phoneExt":28,"email":50},{"name":43,"role":69,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"type":71,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[73,76],{"name":74,"class":75},"Ratchadapiseksompotch Fund","UNKNOWN",{"name":77,"class":75},"The Royal College of Physicians of Thailand","100650682","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-100650682",false,"NCT07748949","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","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","REMIT-DM","Inclusion Criteria:\n\n* 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.\n* Diagnosed with type 2 diabetes mellitus for less than 6 years.\n* Body mass index of 23 kg\u002Fm2 or greater.\n\nExclusion Criteria:\n\n* Receiving more than two oral glucose-lowering medications.\n* Receiving insulin therapy.\n* Use of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) within 3 months before study enrollment.\n* 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.\n* History of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months.\n* Unstable psychiatric disorders within the previous 2 years, including major depressive disorder, bipolar disorder, or schizophrenia.\n* Pregnant or breastfeeding women, or women planning to become pregnant within 12 months.\n* 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\u002Fmin\u002F1.73 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\u002FmL, HIV infection, anemia (hemoglobin less than 10 g\u002FdL), iron deficiency, vitamin B12 deficiency, folate deficiency, thalassemia, glucose-6-phosphate dehydrogenase deficiency, hemolytic anemia, or hemoglobin more than 16 g\u002FdL, heart failure or ischemic heart disease within the previous 6 months.\n* History of blood donation or blood transfusion within the previous 3 months.\n* Uncontrolled diabetic retinopathy or other uncontrolled retinal disease, including maculopathy, based on medical records.\n* 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.\n* Major surgery within 90 days before enrollment or planned major surgery within 6 months after enrollment.\n* No access to a smartphone capable of supporting the study application and internet-based data transmission.\n* Unable to maintain communication with the study investigators according to the study protocol.","ALL","18 Years","70 Years",{"count":90,"type":91},54,"ESTIMATED","INTERVENTIONAL",[94],"NA","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.\n\nThe main questions it aims to answer are:\n\n* 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?\n* 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?\n\nResearchers 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.\n\nParticipants will:\n\n* Be randomly assigned to either the intervention group or the standard care group.\n* Attend study visits for assessments of diabetes-related clinical and metabolic outcomes throughout the 6-month study.\n* 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.",[97,98,99,100],"Type 2 Diabetes","Obesity & Overweight","Remission","Lifestyle Intervention",[102,97,103,104],"Diabetes remission","Obesity","Lifestyle intervention","2026-07-31",{"date":107,"type":108},"2026-08-06","ACTUAL",{"date":110,"type":108},"2026-06-17",{"date":112,"type":91},"2027-07-31",{"name":5,"class":6},1]