Lifestyle Program Tested for Remission of Type 2 Diabetes in Adults With Obesity
Tests a diet, activity and support program in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Remission of Type 2 Diabetes With Lifestyle Intervention
Key facts
- Where
- Split, CroatiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 69 years old?
Source: NCT07017127, who can take part
Where in Croatia
- University of Split School of MedicineSplit, CroatiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Split, School of Medicine
- Trial code
- NCT07017127
- Record updated
- 12 June 2025
- Original description
The goal of this clinical trial is to achieve diabetes type 2 (DM2) remission using intensive lifestyle intervention.Read full original descriptionShow less
Remission of Type 2 Diabetes With Mediterranean Diet, Physical Activity and Psychological Support: a Randomized Clinical Trial
The goal of this clinical trial is to achieve diabetes type 2 (DM2) remission using intensive lifestyle intervention.
The main questions it aims to answer are:
* Does intensive lifestyle intervention (including Mediterranean diet with a caloric deficit, daily physical activity, increase in stress resilience and group support) lead to DM2 remission (HbA1c<6.5%, without medications) * Can intensive lifestyle intervention (including Mediterranean diet with a caloric deficit, daily physical activity, increase in stress resilience and group support) result to weight loss of >15 kg * Does intensive lifestyle intervention result in any side effects (secondary outcome)
Researchers will compare intensive lifestyle intervention to the usual clinical care (control group).
Participants in the experimental group will:
* eat Mediterranean diet with a caloric deficit * perform daily physical activity * increase their stress resilience with psychosocial support of the group * enroll weekly in individual and group counseling and workshops for 6 months, following with 1.5 years of follow-up
Inclusion: type 2 diabetes diagnosis; incident cases or diagnosed not more than 7 years ago; body mass index of 27-45 kg/m².
Exclusion: insulin therapy; heart failure (NYHA III, NYHA IV); chronic kidney disease and estimated glomerular filtration rate <30 ml/min/1.73 m2; heart attack or stroke in the past 1 year; active malignant disease diagnosed in the past 1 year; eating disorders; food allergy; HbA1c >12%; mobility restriction; use of mobility aids; TSH >10 mU/L; 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; active treatment of proliferative diabetic retinopathy with anti-VEGF; pregnancy or pregnancy planning; substance abuse; learning disabilities; acute episode of severe depression; current use of antipsychotics.