About this 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
Eligibility criteria
Qualifiers
type 2 diabetes diagnosis
incident cases or diagnosed not more than 7 years ago
body mass index of 27-45 kg/m²
Disqualifiers
mobility restriction
use of mobility aids
insulin therapy
HbA1c >12%
Trial design
Treatments tested in this trial
- Mediterranean diet
- Physical activity intervention
- Psychological intervention
Treatment groups
Sponsors and collaborators
University of Split, School of Medicine
Lead sponsor
Croatian Science Foundation
Collaborator