Clinical Trial

Remission of Type 2 Diabetes With Lifestyle Intervention

Study acronym: REMeDI2ME
Recruiting
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Summary
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
Trial Details
NCT Number NCT07017127
Lead Sponsor University of Split, School of Medicine
Collaborators: Croatian Science Foundation
Conditions Diabetes Mellitus Type 2, Obese Diabetics
Enrollment 120 participants
Start Date 2025-05-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-12-17 (estimated)
Updated on ClinicalTrials.gov 2025-06-12