Low-calorie diet with intensive lifestyle coaching to help diabetes remission in adults with Type 2 diabetes and overweight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with overweight Type 2 diabetes are randomized to receive a low-calorie diet with intensive lifestyle coaching using integrated personalized diabetes management or standard care. The intervention includes structured education, regular telehealth CGM reviews, two daily 400 kcal meals, and a personalized exercise program, with assessments over several months. Outcomes include diabetes remission rates, glycemic control, weight and body composition, time in range on CGM, quality of life, and cost-effectiveness. The trial collects comprehensive baseline and follow-up data and emphasizes patient activation and mental health, to understand both metabolic and patient-centered effects. This study is led by Chulalongkorn University with regional collaborators in Thailand.

Why it matters

Who can join: the full rules

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.

Where it's running

• King Chulalongkorn Memorial Hospital
  Bangkok, Thailand Recruiting

Study contacts

• Study coordinator: Primploy Greeviroj, M.D., M.S.c.
• Email: primploy.gre@chulahospital.org
• Phone: +66917142555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.