Type 2 diabetes remission through intensive lifestyle changes
Official title: Remission of Type 2 Diabetes With Mediterranean Diet, Physical Activity and Psychological Support: a Randomized Clinical Trial
Run by University of Split, School of Medicine · NCT07017127 · Data updated 2026-11-12
This trial tests whether an intensive lifestyle program—Mediterranean diet with a calorie deficit, daily physical activity, stress-resilience coaching, and group support—can put people with recent type 2 diabetes into remission without diabetes medications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 69 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | University of Split, School of Medicine Academic / other |
| Locations | 1 site (Split) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | June 1, 2027 |
| Study ends | December 17, 2027 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT07017127 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with type 2 diabetes diagnosed within the last seven years, BMI 27–45 kg/m², not on insulin, and able to participate in regular exercise and group sessions are ideal candidates.
✕Probably not a fit
People with long-standing or insulin-treated diabetes, severe heart or kidney disease, mobility restrictions, recent major illness, or certain psychiatric conditions are unlikely to benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional trial compares an intensive lifestyle program to usual clinical care in adults with type 2 diabetes. The intervention combines a calorie-restricted Mediterranean diet, daily physical activity, psychosocial stress-resilience training, and regular group support sessions. Primary outcomes include diabetes remission defined as HbA1c <6.5% off medications and substantial weight loss (>15 kg), with monitoring for any adverse effects. Eligible participants are typically those diagnosed within the past seven years with BMI 27–45 kg/m² and not using insulin.
Why it matters
Potential benefit: If successful, the program could allow some people to stop diabetes medications by achieving normal blood sugar levels and significant weight loss, lowering their risk of long-term complications.
How similar studies have gone: Previous intensive weight-loss programs have produced remission in many people with recent-onset type 2 diabetes, so this approach builds on existing evidence though the exact combination of Mediterranean diet, stress resilience training, and group support is less commonly tested together.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * type 2 diabetes diagnosis * incident cases or diagnosed not more than 7 years ago * body mass index of 27-45 kg/m² Exclusion Criteria: * mobility restriction * use of mobility aids * insulin therapy * HbA1c \>12% * TSH \>10 mU/L * heart failure (NYHA III, NYHA IV) * use of obesity pharmacotherapy (orlistat, GLP-1 receptor agonists, GLP-1/GIP dual agonists) for less than 6 months * weight loss greater than 5 kg in the last 6 months * chronic kidney disease and estimated glomerular filtration rate \<30 ml/min/1.73 m2 * active treatment of proliferative diabetic retinopathy with anti-VEGF * heart attack or stroke in the past 1 year * active malignant disease diagnosed in the past 1 year * eating disorders * pregnancy or pregnancy planning * substance abuse * learning disabilities * acute episode of severe depression * current use of antipsychotics * food allergy
Where it's running
-
University of Split School of Medicine
Split, Croatia Recruiting
Study contacts
- Principal investigator: Ivana Kolčić, Prof, MD, PhD — University of Split, School of Medicine
- Study coordinator: Ivana Kolčić, Professor
- Email: ikolcic@mefst.hr
- Phone: +38515762263
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Proliverenol for liver fat and insulin resistance in type 2 diabetes
This study tests whether adding Proliverenol to standard diabetes care can improve liver fat and blood sugar control in adults with type 2 diabetes.
-
Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes
This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.
-
Safety test of NNC9836-0001 in adults with overweight/obesity or type 2 diabetes
This study tests whether the new medicine NNC9836-0001 is safe and tolerable in adults who are overweight or have type 2 diabetes, compared to placebo.
-
RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes
This study tests the accuracy and safety of the RIGHTEST iFree 2 continuous glucose monitor in pregnant adults with type 1, type 2, or gestational diabetes.
-
EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes
This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.
-
Maridebart cafraglutide vs. semaglutide for type 2 diabetes on metformin
This trial tests whether maridebart cafraglutlide is as good as semaglutide at improving blood sugar in adults with type 2 diabetes who take metformin (with or without an SGLT-2 inhibitor).
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.