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

Recruiting now · Not applicable

Conditions studied: Type 2 Diabetes, Obesity & Overweight, Remission, Lifestyle Intervention

In brief

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.

Key facts

Study ID: NCT07748949
Run by: Chulalongkorn University
People needed: 54
Starts: 2026-06-17
Expected to finish: 2027-07-31
Last updated by the study team: 2026-08-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

King Chulalongkorn Memorial Hospital — Bangkok, Thailand (enrolling)

Full record on ClinicalTrials.gov

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