Diabetes remission Low calorie diet Obesity Telemedicine Diabetes remission Low calorie diet Obesity Telemedicine
Conditions
Interventions
Low-calorie diet consisting of two meal replacements per day, with total daily energy intake restricted to no more than 1,200 kcal/day, together with an individualized exercise program throughout the
Low-calorie diet,Standard care
Sponsors
Ratchadapiseksompotch Fund
Royal College of Physicians of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. 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. 2. Aged 18 to 70 years. 3. Diagnosed with type 2 diabetes mellitus for less than 6 years. 4. Body mass index of 23 kg/m2 or greater.
Exclusion criteria
Exclusion criteria: 1. Receiving more than two oral glucose-lowering medications. 2. Receiving insulin therapy. 3. Use of a glucagon-like peptide-1 receptor agonist (GLP-1 RA) within 3 months before study enrollment. 4. 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. 5. History of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the previous 6 months. 6. Unstable psychiatric disorders within the previous 2 years, including major depressive disorder, bipolar disorder, or schizophrenia. 7. Pregnant or breastfeeding women, or women planning to become pregnant within 12 months. 8. 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. 9. History of blood donation or blood transfusion within the previous 3 months. 10. Uncontrolled diabetic retinopathy or other uncontrolled retinal disease, including maculopathy, based on medical records. 11. 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. 12. Major surgery within 90 days before enrollment or planned major surgery within 6 months after enrollment. 13. No access to a smartphone capable of supporting the study application and internet-based data transmission. 14. Unable to maintain communication with the study investigators according to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diabetes remission 3 months Proportion of participants | — |
Secondary
| Measure | Time frame |
|---|---|
| Diabetes remission 6 months Proportion of participants,HbA1C 3 and 6 months Change/Lab,Body composition and anthropometric measurements 3 and 6 months Change/BIA,Time in Range 3 months Change/CGM,Quality of life 3 and 6 months Score/Questionnaire | — |
Countries
Thailand
Contacts
Public ContactPrimploy Greeviroj
King Chulalongkorn Memorial Hospital
Outcome results
None listed