Actively Recruiting
Remission of Type 2 Diabetes With Lifestyle Intervention
Led by University of Split, School of Medicine · Updated on 2025-06-12
120
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
U
University of Split, School of Medicine
Lead Sponsor
C
Croatian Science Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Remission of Type 2 Diabetes With Lifestyle Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 2 diabetes
- Diagnosis made within the last 7 years or is a new case
- Body mass index between 27 and 45 kg/m²
You will not qualify if you...
- Have mobility restrictions or use mobility aids
- Currently on insulin therapy
- HbA1c level greater than 12%
- Thyroid stimulating hormone (TSH) level over 10 mU/L
- Heart failure classified as NYHA III or IV
- Using obesity medications (orlistat, GLP-1 receptor agonists, GLP-1/GIP dual agonists) for less than 6 months
- Lost more than 5 kg in the last 6 months
- Chronic kidney disease with an estimated glomerular filtration rate below 30 ml/min/1.73 m²
- Receiving active treatment for proliferative diabetic retinopathy with anti-VEGF
- Had a heart attack or stroke within the past year
- Diagnosed with active cancer in the past year
- Have eating disorders
- Pregnant or planning pregnancy
- Substance abuse issues
- Learning disabilities
- Experiencing an acute episode of severe depression
- Currently using antipsychotic medications
- Have food allergies
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Trial Site Locations
Total: 1 location
1
University of Split School of Medicine
Split, Croatia, 21000
Actively Recruiting
Research Team
I
Ivana Kolčić, Professor
CONTACT
L
Lana Barać, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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