Type 2 diabetes remission through intensive lifestyle changes

Remission of Type 2 Diabetes With Mediterranean Diet, Physical Activity and Psychological Support: a Randomized Clinical Trial

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

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 20 Years to 69 Years
• Sex: All
• Sponsor: University of Split, School of Medicine (other)
• Locations: 1 site (Split)
• Trial ID: NCT07017127 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Split

• 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

Conditions: Diabetes Mellitus Type 2, Obese Diabetics, diabetes remission, Mediterranean diet, physical activity, stress, weight loss, healthy lifestyle