Remission of Type 2 Diabetes With Lifestyle Intervention
Recruiting now · Not applicable
Conditions studied: Diabetes Mellitus Type 2, Obese Diabetics
In brief
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
Key facts
- Study ID
- NCT07017127
- Run by
- University of Split, School of Medicine
- People needed
- 120
- Starts
- 2025-05-01
- Expected to finish
- 2027-12-17
- Last updated by the study team
- 2025-06-12
Who can join
Age: 20 and older, up to 69. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- type 2 diabetes diagnosis
- incident cases or diagnosed not more than 7 years ago
- body mass index of 27-45 kg/m²
You may not qualify if…
- 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 it is running
- University of Split School of Medicine — Split, Croatia (enrolling)
Full record on ClinicalTrials.gov
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