Remission of Type 2 Diabetes With Lifestyle Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-69
SponsorUniversity of Split, School of Medicine

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

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Split, School of Medicine

Lead sponsor

Croatian Science Foundation

Collaborator