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Remission of Type 2 Diabetes With Lifestyle Intervention

RecruitingNAAges 20 Years - 69 YearsAllUniversity of Split, School of Medicine
NCT07017127 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 act

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📋 Eligibility rules (as published)
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
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What it tests

  • Mediterranean diet
  • Physical activity intervention
  • Psychological intervention
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Where

1 site
University of Split School of Medicine
Split, Croatia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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