Can a strict diet put type 2 diabetes into remission?
NCT ID NCT07748949
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial tests whether a low-calorie diet combined with intensive lifestyle coaching can help adults with type 2 diabetes achieve remission—meaning blood sugar levels return to normal without medication. Participants are randomly assigned to either the intervention or standard care. The intervention includes meal replacements, personalized meal plans, exercise, continuous glucose monitoring, and telemedicine support over six months. The study aims to see if this approach increases the chance of remission and improves overall metabolic health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Low-calorie diet combined with intensive lifestyle intervention using Integrated Personalized Diabetes Management (iPDM)
- What this could lead to
- If successful, this approach could offer a drug-free path to diabetes remission, potentially reducing or eliminating the need for glucose-lowering medications in some adults with type 2 diabetes.
- What could go wrong
- The trial is small (54 participants) and the remission may not be durable or achievable for everyone. The intensive diet and lifestyle changes require significant commitment, and results may not generalize to broader populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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King Chulalongkorn Memorial Hospital
RECRUITINGBangkok, 10330, Thailand
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