Remission of Type 2 Diabetes With Lifestyle Intervention
About this study
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
- Condition
- Diabetes Mellitus Type 2, Obese Diabetics
- Tested
- Mediterranean diet, Physical activity intervention, Psychological intervention
- Sponsor
- University of Split, School of Medicine
Who can join
- Age
- 20 to 69 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 20 years
- Maximum age: 69 years
- Study condition: Diabetes Mellitus Type 2, Obese Diabetics
- type 2 diabetes diagnosis
- incident cases or diagnosed not more than 7 years ago
- body mass index of 27-45 kg/m²
Exclusion 19
- 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
Where
1 site, 1 recruiting
University of Split School of Medicine
Split, Croatia
Contact
-
Ivana Kolčić, Professor
+38515762263 ikolcic@mefst.hr
-
Lana Barać, PhD
Potential match only. Final eligibility is determined by the study team.